Better health and ageing for all Australians

Office of Chemical Safety and Environmental Health

Acceptable Daily Intakes for Agricultural and Veterinary Chemicals

This document sets out the acceptable daily intakes (ADIs) for agricultural and veterinary chemicals used on food producing crops or animals. It includes entries that were recommended by the former Pesticides and Agricultural Chemicals Standing Committee of the National Health and Medical Research Council until November 1992 and those established by the TGA since assuming responsibility for establishing ADI's on 12 March 1993.

Current as of 31 December 2008

Printable version of the Acceptable Daily Intakes for Agricultural and Veterinary Chemicals (PDF 654 KB)


© Commonwealth of Australia 2005

ISSN 1446-1412

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This document includes recommendations made by the former Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) and by the Office of Chemical Safety (OCS) in the Office of Health Protection (OHP).

Any comments or enquiries relating to the entries in this document should be addressed to:

The Office of Chemical Safety
Office of Health Protection
Department of Health and Ageing
MDP 88
GPO Box 9848
CANBERRA ACT 2601

Preface

This document sets out the acceptable daily intakes (ADIs) for agricultural and veterinary chemicals used on food producing crops or animals. It includes entries which were recommended by the former Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) until November 1992.

The responsibility for setting ADIs transferred to the Therapeutic Goods Administration (TGA) of the Australian Department of Health and Ageing on 12 March 1993. ADIs established by the Office of Chemical Safety (OCS) in the Office of Health Protection (OHP) are included in this document.

Introduction

Over the past several decades, pesticides and other agricultural chemicals and veterinary drugs have become an important factor in food production. The availability of these chemicals has enabled significant increases in agricultural productivity to be achieved.

While the consumption of agricultural and veterinary chemicals is not desirable in itself, ingestion of these substances in the form of residues in agricultural produce may occur as a consequence of their intended use. Residues resulting from proper agricultural use are low as has been consistently demonstrated in Market Basket Surveys. Nevertheless, it is essential that a mechanism exists to assess the likelihood of risks to the public, and to reduce these risks to a minimum.

Prior to the registration of an agricultural or veterinary chemical product, applicants must provide registration authorities with a great deal of information in support of the use of the product, including details of toxicological studies. The toxicological studies are assessed with a view to determining the potential hazards associated with exposure to the chemical and also, where the chemical is used on food producing crops or animals, to establishing a level of intake which would be without appreciable risk to consumers. The toxicological hazards of existing chemicals are reviewed as further data becomes available.

Toxicological studies required for agricultural and veterinary chemicals range from those measuring single dose effects to those which examine the effects of lifetime exposure. Toxicity studies are generally performed on laboratory animals such as mice, rats, rabbits, and dogs and are designed to identify potential toxic effects. The studies usually involve the feeding/administration of various levels of the compound under investigation to animals, followed by observation and monitoring of clinical parameters and pathology which are indicative of toxicity in the test species.
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The range of toxicological studies required to be undertaken is detailed in the “Ag Manual: The Requirements Manual for Agricultural Chemicals” and the “Vet Manual: The Requirements Manual for Veterinary Chemicals” which are published by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The immediate hazards from a chemical are determined by identifying the acute toxicity by the most likely routes of exposure, together with tests for skin and eye irritation and skin sensitisation. The potential for toxicity over longer periods, including possible tumour induction, is determined by studying the effects of repeated dosing, in some cases for the entire lifespan of the species. Multigeneration and developmental studies predict reproductive toxicity and the potential to cause birth defects, and studies are performed to assess the potential to cause effects on genetic material. Other specific investigations also may be required to clarify the mechanism of toxicity of a particular chemical.

Designs for the conduct of toxicological studies have become standardised to a large extent and international guidelines have been developed to achieve consistency in experimental techniques. In general, groups of the test species/organism are exposed to a number of dose levels (usually three) of the substance and a further group is left unexposed (control group). The treatment levels are selected so that the highest dose will cause some obvious toxic effects, while the lowest dose at least, should not result in a toxic effect. During the course of the study a range of observations is made in each group and a comparison is made of the findings in each treated group versus the control group.

Assessment of individual toxicity studies includes the determination of a no-observable-effect level (NOEL), which is the highest administered dose which does not cause any detectable (usually adverse) effect in the study. The overall NOEL for a chemical, determined in the most sensitive species, is then used to estimate the acceptable daily intake.

The acceptable daily intake (ADI) for humans is considered to be a level of intake of a chemical that can be ingested daily over an entire lifetime without any appreciable risk to health. It is calculated by dividing the overall NOEL from the animal studies by a safety factor. The magnitude of the safety factor is selected to account for uncertainties in extrapolation of animal data to humans, variation between humans, the completeness of the toxicological data base and the nature of the potential adverse effects.

The most common safety factor is 100 which takes into account that humans may be 10 times more sensitive to the chemical than experimental animals and that a proportion of the population may be 10 times more sensitive than the average person. Where there is satisfactory information in humans, there is no necessity to extrapolate from animal data and a safety factor of 10 is considered adequate to account for inter-individual variation. On the other hand when the toxicity data base is incomplete or when the nature of the potential hazards indicate the need for additional caution, a further safety factor of 10 to 20 may be incorporated. In these situations, the overall NOEL is divided by a safety factor of 1000 to 2000 in determining the ADI.

It is important to note that the toxicological studies on which the overall NOEL is based are invariably carried out by oral dosing of animals and usually by incorporation of the chemical in the diet. The subsequent establishment of an ADI is thus directed to human exposure by the oral route. Due to possible differences in absorption and other kinetic and metabolic parameters, the comparison of intakes by other routes with the ADI should be interpreted with caution.
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Notes

1. Use of the terms JMPR or JECFA in the NOEL column indicates that the Australian ADI has been adopted from the figure established by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) or the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
2. (H) indicates that the NOEL was determined on the basis of experimental data in humans.
3. The words "not necessary" in the ADI column indicates that there is a large margin of safety for consumption of residues in food when the chemical is used according to good agricultural/veterinary practice. Due to low levels of residues and the lack of oral activity of these chemicals, a numerical ADI is not considered necessary.
4. (M) indicates that the ADI is derived from microbiological data.
5. TDI means Tolerable Daily Intake. ADIs are not maintained for those agricultural and veterinary chemicals that are no longer permitted for use in agricultural practice. However, residues of certain environmentally persistent pesticides may occur as residues in agricultural commodities as a consequence of past use. In these cases, health intake values are maintained as Tolerable Daily Intake values, to serve as a guideline with which potential dietary intakes of these environmentally persistent chemicals can be compared.
6. 'Deleted' means that an ADI had previously been established but that the chemical is no longer permitted for use on food-producing crops or animals. (For certain environmentally-persistent chemicals which are no longer used in agriculture, see note 5 re TDI values.)
Chemical
ADI (mg/kg bw)
NOEL (mg/kg bw)
DateSet
Study
Comments

a

 

 

 

 

 

Abamectin

0.0005

0.5

10 Nov 1999

3-week rabbit developmental study; based on teratogenicity at the next highest dose of 1 mg/kg bw/day.

1000 fold safety factor justified as the foetal abnormalities produced may represent an acute toxic effect.

Acephate

0.003

0.22

10 Feb 1988

 

 

Acetamiprid

0.1

9

27 Jul 2001

2-year dietary study in rats; based on reductions in bodyweight gain and food consumption, and increased incidence of hepatocellular hypertrophy and vacuolation at the next highest dose

 

Acetyl isovaleryltylosin tartrate

0.0001

0.031 (MIC50)

21 Aug 2006

A microbiological ADI of 0.0001 mg/kg bw/d was established for acetyl isovaleryltylosin tartrate, based on a MIC50 of 0.031 mcg/ml in the most sensitive bacterial genus, (Bifidobacterium) found in the human GI tract.

A toxicological ADI of 0.05 mg/kg bw/d was based on a NOEL of 47 mg/kg bw/d in a 3-month mouse dietary study and a safety factor of 1,000.

Acibenzolar-S-methyl

0.005

5 [LOEL]

23 Apr 2002

12-month chronic oral toxicity study in dogs; based on haematological changes associated with anaemia seen at a LOEL of 5 mg/kg bw/d.

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Acifluorfen

0.015

1.5

8 May 1980

 

 

Acinitrazole

0.005

10

18 Mar 1976

 

 

Acrolein

0.0005

0.05

15 Mar 1994

24-month rat gavage study; based on mortality and serum biochemical effects at the next highest dose of 0.5 mg/kg bw/day.

 

Alachlor

0.0005

0.5

3 May 1985

 

 

Albendazole

0.05

5

9 Aug 1994

 

 

Aldicarb

0.001

0.01 (H)

15 Dec 1999

Single dose human study; based on plasma and erythrocyte ChE inhibition at the next highest dose of 0.025 mg/kg bw.

 

Aldoxycarb

0.001

1.8

1 Aug 1985

 

 

Aldrin

0.0001 (TDI)

JMPR'94

21 Oct 2003

 

Tolerable daily intake. Traditional ADI not maintained as aldrin is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. end-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Aliphatic alcohol ethoxylates

0.01

20

15 Aug 1979

 

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Alloxydim-sodium

0.05

5

14 Aug 1980

 

 

Alpha-cypermethrin

0.05

4.7

11 Mar 1994

13-week dog study; a NOEL of 90 ppm (4.7 mg/kg bw/day) was based on ataxia, body tremors, agitation and abnormal gait at the next highest dose of 270 ppm.

 

Alpha-trenbolone

0.0001

0.01

10 Feb 1988

 

 

Altrenogest

0.000002

0.004

13 Aug 1992

 

 

Ametryn

0.02

2

17 Nov 1989

 

 

Amicarbazone

0.02

2

9 Jun 2006

 

 

Aminocarb

0.02

2

10 Feb 1969

 

 

Aminoethoxyvinylglycine

0.0002

0.2

28 Sep 2000

90-day rat dietary study; based on a reduction in blood AST levels at the next highest dose of 0.4 mg/kg bw/d.

A subchronic study was used in the absence of a chronic study, hence a conservative safety factor is warranted.

Amitraz

0.002

0.25

5 Nov 1986

 

 

Amitrole

0.0003

0.025

3 May 1984

 

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Amoxycillin

0.2

200

8 Mar 1995

 

 

Apramycin

0.05

5

29 May 1986

 

 

Ardacin

0.05

100

1 Dec 1988

 

 

Arprinocid

0.002

4

10 Nov 1977

 

 

Asulam

0.02

40

5 Dec 1985

 

 

Atrazine

0.005

0.5

5 Dec 1990

Rat 2-year dietary study; NOEL of 10 ppm based on mammary tumours in female rats. The LOEL in this study was 1.17 mg/kg, with nephrotoxicity at this dose.

 

Avilamycin

1

108

19 Dec 1997

24-month rat dietary study; based on absence of toxicity effects at the highest dose of 3000 ppm (108 mg/kg bw/day).

 

Azaconazole

0.025

2.5

2 Jun 1988

 

 

Azadirachtin

not established

 

28 May 2004

 

ADI not established; due to insufficient information.

Azafenidin

0.0004

0.04

4 Jul 2001

3-month dog study; based on porphyrin and pigment accumulation in the liver and other liver toxicity.

 

Azamethiphos

0.003

0.25

29 May 1996

52-week dog dietary study; a NOEL of 10 ppm (0.25 mg/kg bw/d) was based on inhibition of plasma, RBC and brain ChE activity at the next highest dose of 100 ppm.

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Azaperone

0.1

10

5 Aug 1983

 

 

Azimsulfuron

0.2

18

9 Sep 2002

12-month dietary study in male dogs; based on reduced bodyweight gain and increased pigment deposition at the next highest dose of 3000 ppm (the highest dose

 

Azinphos-ethyl

0.002

0.02 (H)

21 Jun 1991

 

 

Azinphos-methyl

0.025

0.25 (H)

26 Aug 2002

28-day repeat-dose human study; based on no inhibition of plasma or RBC ChE (or any other related effects) in males at 0.25 mg/kg bw/d, the only dose tested.

 

Azocyclotin

0.003

0.25

10 Jun 1987

 

 

Azoxystrobin

0.1

10

29 Sep 1998

3-month oral dosing dog study; based on reduced body weights and increased salivation and gastrointestinal abnormalities at the next highest dose of 50 mg/kg/day.

 

b

 

 

 

 

 

Bacillus thuringiensis

not necessary

 

6 Sep 2002

 

ADI not necessary [compound is a naturally occurring organism and residues from its use on sheep are likely to be indistinguishable from naturally occurring background levels of the organism].

Bacillus thuringiensis subsp. thuringiensis serotype 1 (strain MPPL 002)

not necessary

 

28 Aug 2003

 

ADI not necessary; compound is a naturally occurring organism and residues from its use on sheep are likely to be indistinguishable from naturally occurring background levels of the organism.

Bacitracin

0.1

10

26 May 1997

Rat developmental rat study; a NOEL of 75 mg/kg/day Albac (10 mg/kg/day bacitracin) was based on increased salivation and reduced body weight gain at the next highest dose of 225 mg/kg/day.

Safety factor of 100 deemed appropriate due to the poor gastrointestinal absorption of bacitracin.

Bambermycin

0.3

29

14 Sep 2001

2-year chronic study in rats.

Previously named:flavophospholipol

Benalaxyl

0.05

5

1 Dec 1988

 

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Bendiocarb

0.004

0.4

8 Jun 1993

Rat reproduction study; based on reduced maternal weight gain at the next highest dose of 2 mg/kg

 

Benfluralin

0.05

5

18 Feb 1987

 

 

Benfuresate

0.01

20

10 Sep 1987

 

 

Benomyl

0.02

2.5

12 Feb 2003

2-year dog study; based on an increase in testicular degeneration at the next highest dose of 12.5 mg/kg bw/d.

 

Bensulfuron-methyl

0.02

2.5

10 Sep 1987

 

 

Bensulide

0.04

4

4 Feb 1982

 

 

Bentazone

0.01

10

1 Dec 1975

 

 

Benzofenap

0.004

0.4

27 Mar 1998

2-generation rat reproduction study; A NOEL of 5 ppm (0.4 mg/kg/day) was based on reduced pup survival at the next highest dose of 20 ppm.

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Benzyl G Penicillin

0.03 mg/person/d

JECFA'90(H)

28 Feb 1990

 

 

6-Benzyladenine

0.02

30

15 Aug 1979

 

 

Beta-cyfluthrin

0.01

1.5

5 Dec 1990

13-week dog dietary study; a NOEL of 60 ppm (1.5 mg/kg bw/day) was based on vomiting, diarrhoea and effects on motor function at the next highest dose of 360 ppm.

 

Beta-cypermethrin

0.05

5

19 Mar 2002

2-year rat study; based on a NOEL for cypermethrin.

The 2-year rat study used for establishing the cypermethrin ADI was considered appropriate to use for the beta-cypermethrin ADI as all the isomers contained in beta-cypermethrin are contained in cypermethrin.

beta-Trenbolone

0.00001

0.001

10 Feb 1988

 

 

Bifenazate

0.01

1

12 Dec 2002

Rat 2-year dietary study, and a 52- week dietary study in dogs; based on a decreased bodyweight gain in the rat study at the next highest dose of 4.8 mg/kg bw/d; and decreased bodyweight gain, haematological and clinical chemistry effects, urine changes, organ weight changes and histopathological effects in the dog study at the next highest dose of 8.95 mg/kg bw/d.

 

Bifenthrin

0.01

1

26 Nov 1992

Developmental rat gavage study; based on maternal tremors at the next highest dose of 2 mg/kg

 

Binapacryl

0.002

0.25

3 Aug 1984

 

 

Bioresmethrin

0.03

3

20 Jun 1991

2-year rat dietary study; based on hepatotoxicity at the next highest level of 15 mg/kg bw/d.

 

Bitertanol

0.01

1

15 Nov 1982

 

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Boscalid

0.06

6

15 Aug 2003

Rat carcinogenicity and chronic 2- year dietary studies; based on NOELs of 100 ppm (equivalent to 6 mg/kg/d) due to clinical signs at the next highest dose of 500 ppm.

 

Brodifacoum

0.0000005

0.001

16 May 1990

 

 

Bromacil

0.1

10

10 Feb 1988

 

 

Bromadiolone

0.000002

0.004

18 Jan 1994

Rabbit developmental study; a NOEL of 4 ug/kg/day (0.004 mg/kg/day) was based on maternotoxicity, increased resorptions and reduced foetal weight at the next highest dose of 8

 

Bromide

1

JMPR'88

30 Sep 1988

 

 

Bromophos-ethyl

0.004

0.4

18 Feb 1987

 

 

Bromopropylate

0.03

2.8

31 May 1994

12-month dog dietary study; a NOEL of 100 ppm (2.8 mg/kg bw/day) was based on decreased body weight gain in females at the next highest dose of 400 ppm.

 

Bromoxynil

0.003

0.3

19 Feb 1993

1-year dog study; based on reduced body weight gain at the next highest dose of 1.5 mg/kg bw/day.

 

Bromsalans

0.007

15

12 Aug 1970

 

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Bromuconazole

0.02

2

17 Jun 1994

2-year rat dietary study; a NOEL of 20 ppm (2 mg/kg bw/day) was based on pathological effects in the liver at the next highest dose of 150 ppm.

 

Brotianide

0.0008

1.7

9 Aug 1972

 

 

Bupirimate
0.05
5
7 June 1978    

Bupivacaine

0.001

1.0

10 June 2008

Iv infusion of a dose of 75 mg bupivacaine salt over 10 minutes to volunteers resulted in mean arterial plasma concentrations of approximately 5 µg base/mL; no signs of toxicity were recorded (Tucker and Mather, 1975). Therefore in the absence of adequate repeat dose toxicity studies, an ADI of 0.001 mg/kg bw was established using a LOEL of 1 mg/kg bw, and applying a 1000-fold safety factor.

The 1000-fold safety factor represents uncertainties associated with the use of a LOEL (10-fold), intraspecies variation (10-fold), and an inadequate toxicological database (10-fold).

Buprofezin

0.01

1

18 Jan 2000

2-year rat study and a rat two generation reproduction study; based on NOELs of 1 and 0.9 mg/kg bw/d respectively.

 

Butacarb

0.2

20

7 Dec 1972

 

 

Butachlor

0.005

10

7 Dec 1972

 

 

Butafenacil

0.004

0.36

12 Apr 2001

18-month mouse carcinogenicity study; based on a NOEL of 0.36 mg/kg bw in males.

 

Buthidazole

0.008

15.8

7 Jun 1978

 

 

Butralin

0.2

15

14 Aug 1992

Developmental gavage rabbit study; based on maternal toxicity (reduced body weight gain) and foetal defects at the next highest dose of 45 mg/kg bw/day.

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Butroxydim

0.005

0.5

18 Jan 1993

1-year dietary dog study; based on organ weight changes and increased ALP levels at the next highest dose of 5 mg/kg bw/day.

 

c

 

 

 

 

 

Cadusafos

0.00001

0.001

13 Aug 1992

1-year oral dog study; a NOEL of 1 ug/kg bw/day (0.001 mg/kg bw/day) was based on plasma CHE inhibition in females at the next highest dose of 5 ug/kg bw/day.

 

Captan

0.1

10

5 Feb 1997

Rabbit reproduction study; based on increased incidence of cysts on the liver and an increase in the number of skeletal variations at the next highest dose of 30 mg/kg

 

Carbaryl

0.008

16 [LOEL]

13 Dec 2002

2-year mouse dietary study; based on vascular tumour formation at the LOEL of 16 mg/kg bw/d (100 ppm).

 

Carbendazim

0.03

2.5

9 May 1979

 

 

Carbendazole

0.1

10

11 Nov 1976

 

 

Carbetamide

0.03

3

30 Aug 1991

 

 

Carbofuran

0.003

0.33

10 Sep 1987

 

 

Carbophenothion

0.0002

0.02

12 Aug 1970

 

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Carbosulfan

0.01

1

17 Jan 1997

2-year rat dietary study; a NOEL of 20 ppm (1 mg/kg bw) was based on clinical signs, iris atrophy and cholinesterase inhibition at the next highest dose of 500 ppm.

 

Carboxin

0.08

8.5

18 Feb 1987

 

 

Carfentrazone ethyl

0.03

3

3 Aug 1998

2-year rat dietary study; a NOEL of 50 ppm (3 mg/kg/day) was based on red fluorescence seen in the female liver at the next highest dose of 200 ppm.

 

Carprofen

0.005

1

4 Sep 1997

2-year rat dietary rat study; based on nephrotoxicity and gastro-intestinal tract ulceration at the next highest dose of 3 mg/kg/day.

 

Ceftiofur sodium

0.03

30

18 Jan 1993

90-day oral dog study; based on clinical signs, reduction in platelet counts in female (thrombocytopenia) at the next highest dose of 100 mg/kg bw/d.

High safety factor due to lack of chronic studies.

Cefuroxime sodium

0.4

400

12 Aug 1996

27-week gavage dog study; based on anaemia, reduced plasma cholesterol, and increased triglycerides at the next highest dose

 

Cephalexin

0.01

(M)

22 Nov 2000

 

The limited toxicology data were not sufficient to allow establishment of a toxicological ADI. A microbiological ADI of 0.01 mg/kg bw/d for cephalexin based on the use of the JECFA formulation was established.

Cephalonium

0.02

39

11 Jul 1996

13-week rat study; a NOEL of 500 ppm (39 mg/kg/day) was based on elevated kidney weights at the next highest dose of 5000 ppm.

High safety factor chosen to reflect absence of chronic and reproduction toxicity studies.

Cephapirin
0.02
20
5 Sep 1997 13-week oral dog study; based on vomiting and increased weight gain at the LOEL of 20 mg/kg bw/day. High safety factor due to use of a LOEL and the absence of chronic/oncogenicity studies.

Cetrimide

0.01

25

10 June 2008

In a repeat dose study in which cetrimide was administered to rats at concentrations of 0, 25 and 50 mg/kg bw/d for 21 days, there was a dose-related reduction in body weight gain and food consumption (EMEA, 1996). An ADI of 0.01 mg/kg bw/d cetrimide was established using a LOEL of 25 mg/kg bw/d and applying a 2000-fold safety factor.

The 2000-fold safety factor represents the uncertainty associated with using a LOEL, inter- and intra-species extrapolation and the limited database.  In establishing this ADI, it was taken into account that cetrimide has been used extensively in humans for topical use, and has been associated with an extremely low number of adverse reactions.

Chloraniformethan

0.03

2.5

14 Nov 1974

 

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Chlorantraniliprole

1.58

158

9 May 2008

In the chronic mouse study, the dosing levels were: 0, 2.6/3.34, 9.20/11.6, 26.1/32.9, 158/196 or 935/1155 mg/kg bw/d (males/females). In both sexes, absolute and relative liver weights were statistically significantly increased (6-19%) at the two top doses. In males, the incidence of centrilobular hepatocellular hypertrophy was also increased relative to controls, in a statistically significant manner at the two highest doses. These otherwise adaptive effects support the findings of eosinophilic foci at the high dose in male mice. In males, eosinophilic foci of cellular alteration, were present in 0/70, 1/70, 1/70, 0/70, 1/70 and 5/70 mice given 0, 2.60, 9.20, 26.1, 158 or 935 mg/kg bw/d. The eosinophilic foci are not considered an adaptive response because they are not reversible nor are they commonly associated with a normal liver response to xenobiotics (historical control range 0-1.92%) for Crl:CD-1 (ICR) mice).

A LOEL of toxicological significance is established at 935 mg/kg/day for male mice based on eosinophilic foci of cellular alteration accompanied by hepatocellular hypertrophy and increased liver weight. The NOEL in the study is thus 158 mg/kg bw/d.

Chlordane

0.0005 (TDI)

JMPR'94

21 Oct 2003

 

Tolerable daily intake. Use of chlordane in food-producing animals has been withdrawn. Therefore, an ADI for this compound is not necessary.

Chlordimeform

0.003

0.3

10 Sep 1987

 

 

Chlorfenapyr

0.02

2.1

22 Aug 1995

12-month dog dietary study; based on elevated creatine levels at the next highest dose of 4 mg/kg/day.

 

Chlorfenvinphos

0.0005

0.05

29 Oct 1998

4-week, 2-year dietary study and 2- generation reproduction studies in rats; based on plasma and/or brain ChE inhibition.

 

Chlorfluazuron

0.005

0.56

12 Nov 1987

 

 

Chlorhexidine

0.2

25

14 Feb 1985

 

 

Chloridazon

0.04

4.1

2 Dec 1988

 

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Chlormequat

0.07

7.5

30 Aug 1991

2-year dog dietary study; a NOEL of 300 ppm (7.5 mg/kg bw/day) was based on excessive salivation and muscle weakness at the next highest dose of 1000 ppm.

 

Chlornidine

0.002

5

9 Aug 1972

 

 

Chloromethiuron

0.004

0.4

10 Sep 1987

 

 

Chlorothalonil

0.01

1.5

14 Feb 1991

 

 

Chloroxuron

0.004

0.4

14 Feb 1992

 

 

Chlorpropham

0.05

5

16 Jul 1996

60-week dog dietary dog study; based on altered thyroid function at the next highest dose of 51

 

Chlorpyrifos

0.003

0.03 (H)

17 Dec 1998

28-day human volunteer study; based on plasma ChE inhibition.

 

Chlorpyrifos-methyl

0.01

0.1

10 Feb 1988

 

 

Chlorsulfuron

0.05

5

5 Aug 1982

 

 

Chlortetracycline

0.003

0.03(H)

15 May 1995

7-day human oral study: a NOEL of 2 mg/adult/day (0.03 mg/kg bw/d) was based on the elimination of oxytetracycline susceptible strains of intestinal microflora at the next highest dose of 20 mg/adult/day.

The NOEL of oxytetracycline has been applied to chlortetracycline due to similarities in structure and microbiological potency.

Chlorthal-dimethyl

0.01

1

29 Apr 1994

 

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Chlorthiophos

0.0002

0.02

7 Jun 1978

 

 

Cinmethylin

0.01

11 [LOEL]

20 Aug 2003

Rat reproduction study; based on a LOEL of 11 mg/kg/d in adults due to the increased incidence of parenchymal hepatocellular vacuolation in female livers at all treatment levels.

The LOEL was considered appropriate, as the figure is lower than the lowest clear NOEL of 3 mg/kg/d in a rabbit developmental study, with a safety factor of 100.

Clavulanic acid

0.01

10

8 Mar 1995

6-month gavage dog study; based on liver toxicity at the next highest dose of 20 mg/kg bw/day.

High safety factor due to incomplete database; no chronic studies

Clenpyrin

0.003

5

7 Dec 1971

 

 

Clethodim

0.01

1

20 Jun 1991

 

 

Clodinafop-propargyl

0.004

0.37

28 Apr 1994

3-month dietary dog study; a NOEL of 10 ppm (0.37 mg/kg bw/day) was based on skin lesions and disturbances of the serum protein electrophoretic pattern at the next highest dose of 50 ppm.

 

Clofentezine

0.02

2

11 Sep 1986

 

 

Clomazone

0.1

14

19 Dec 1997

12-month dog dietary study; a NOEL of 500 ppm (14 mg/kg bw/day) was based on increased absolute and relative liver weights at the next highest dose of 2500 ppm.

 

Cloprostenol

0.0005

0.05

11 Nov 1975

 

 

Clopyralid

0.5

50

12 Nov 1982

 

 

Cloquintocet-mexyl

0.04

4

28 Apr 1994

 

 Top of page

Clorsulon

0.001 mg/kg bw

0.2

19 Jun 2007

54-week study in rats

 

Closantel

0.025

2.5

12 Nov 1981

 

 

Clothianidin

0.05

9.7 [LOEL]

1 Aug 2003

Rat 2-year feeding study; based on a LOEL of 9.7 mg/kg bw/day, with a safety factor of 200 warranted, as the incidence of the effect in the ovaries was only slightly higher than the historical control range.

A NOEL was not established due to interstitial cell hyperplasia observed in the ovaries in all treated groups.

Cloxacillin

0.2

500

28 Jun 2001

12-week rat oral study; based on absence of haematological, biochemical, histological organ weight abnormalities at the highest dose of 500 mg/kg bw.

High safety factor due to limited toxicology information.

Cloxylacon

0.002

4.1

11 May 1989

 

 

N-coco-1,3-diaminopropane

not necessary

 

10 Dec 2003

 

ADI not necessary [as it will not result in human exposure via the diet

Colistin sulphate

0.2

25

5 Dec 1990

 

 

Copper

0.2

 

16 Jun 2005

 

This ADI is based on the upper safe limit for adults of 0.2 mg/kg bw/d recommended by FSANZ as a provisional maximum tolerable daily intake. Therefore there is no NOEL, LOEL or safety factor.

Coumaphos

0.0005

0.05

7 Dec 1971

 

 Top of page

Coumatetralyl

0.000003

0.0068

15 Sep 2000

16-week sub-chronic oral rat study.

The safety factor was chosen due to the limited toxicology database.

Crotoxyphos

6e-005

0.12

7 Jun 1972

 

 

Crufomate

0.1

JMPR'68

19 Aug 1974

 

 

Cyanamide

0.002

0.2

14 Aug 1992

 

 

Cyanatryn

0.05

5

6 Aug 1975

 

 

Cyanazine

0.002

0.2

11 Sep 1986

 

 

Cyclanilide

0.01

2.5

17 Apr 1998

2-generation rat reproduction study; a NOEL of 30 ppm (2.5 mg/kg bw/day) was based on alterations in organ weight at the next highest dose of 300 ppm.

 

Cyclodextrins

deleted

 

21 Oct 2003

 

The need to establish ADIs to support short-term exposure to experimental pesticides resulting from their use under a permit approval had been largely overcome by the introduction of ARfD's. Hence there is no longer any justification to retain an ADI for cyclodextrins

Cycloprate

0.004

8

9 Feb 1977

 

 

Cycloprothrin

0.01

1

29 May 1986

 

 Top of page

 
     

Cycloxydim

0.06

6.4

17 May 1990

 

 

Cyfluthrin

0.02

2.5

14 Feb 1985

 

 

Cyhalofop-butyl

0.002

0.2

28 Jan 2005

2-year rat study; based on increased incidence of spots in the livers of females at 2.4 mg/kg bw/d.

 

Cyhalothrin

0.02

1.5

14 Feb 1985

 

 

Gamma-cyhalothrin

0.0005

0.5

12 Aug 2003

Rat developmental study; maternal NOEL based on decreased body weight gain and clinical signs at the next highest dose of 2 mg/kg bw/d.

 

Cyhexatin

0.001

0.1

18 Jan 2000

Rat developmental study; based on decreased body weight gain at 0.5 mg/kg bw/day.

 

Cymiazole

0.005

0.5

14 Feb 1985

 

 

Cynmethylin

0.006

12

6 Feb 1986

 

 

Cyometrinil

0.0005

1

5 May 1982

 

 

Cypermethrin

0.05

5

10 Feb 1988

 

 

Cyphenothrin

0.03

3

30 Aug 1991

 

 

Cyproconazole

0.01

1

22 Feb 1990

12-month dog dietary study; a NOEL of 30 ppm (1 mg/kg bw/day) was based on hepatotoxicity at the next highest dose of 100 ppm.

 

Cyprodinil

0.02

2.7

19 Aug 1994

2-year rat dietary study; a NOEL of 75 ppm (2.7 mg/kg bw/day) was based on increased incidence of liver lesions in males at the next highest dose of 1000 ppm.

 

Cyromazine

0.02

1.8

8 Apr 1998

24-month dietary rat study; a NOEL of 30 ppm (1.8 mg/kg/day) was based on depressed weight gain at the next highest dose of 300 ppm.

 

d

 

 

 

 

 

Daminozide

0.7

75

11 Sep 1986

 

 

Dazomet

0.0005

0.5

27 Nov 1996

 

 

DDT

0.002 (TDI)

0.25

21 Oct 2003

 

Tolerable daily intake. Traditional ADI not maintained as DDT is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. end-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Decoquinate

0.007

15

11 Jul 1969

 

 

Deltamethrin

0.01

1

6 Nov 1980

 

 Top of page

Demeton-S-methyl

0.0003

0.03

30 Aug 1991

12-month dog dietary study; a NOEL of 1ppm (0.036 mg/kg bw/day) was based on depressed CHE levels at the next highest dose of 10 ppm.

 

Dexamethasone

0.000015

JECFA'94

10 Aug 1994

 

 

Diafenthiuron

0.003

0.3

5 Jan 1993

12-month oral dog study; based on reduced body weight gains at the next highest dose of 1.5 mg/kg

Supported by a 24-month dietary rat study; a NOEL of 10 ppm (0.32 mg/kg bw/day) was based on increased urinary volume and testicular enlargement at the next highest dose of 30 ppm.

Dialifos

0.001

0.01

16 Jul 1978

 

 

Diazinon

0.001

0.02 (H)

29 Apr 1999

37-43 Day human study; based on plasma ChE inhibition.

 

Dicamba

0.03

3

20 Jun 1991

Developmental rabbit study; based on reduced maternal body weight gains at the next highest dose of 10 mg/kg bw/day.

 

Dichlobenil

0.01

1.25

14 Aug 1992

 

 Top of page

Dichlofluanid

0.03

2.7

29 May 1986

 

 

2,4-dichlorophenoxyacetic acid

0.01

1

23 Jun 2006

Two-year rat study; based on abnormal renal morphology at the next higher dose of 5 mg/kg bw/d. year dog study.

The ADI was supported by the same NOELs (based on kidney effects) observed in a 2-year mouse and 1 year dog study

Dichlorprop

0.03

3.1

9 Jul 1998

13-week dog dietary study; a NOEL of 75 ppm (3.2 mg/kg bw/day) was based on changes in clinical chemistry and kidney discolouration at the next highest dose of 300 ppm.

 

Dichlorprop-P

0.03

6

2 Nov 2006

18-month mice dietary study, based on an increased incidence of chronic nephropathy observed in male mice at the next highest dose and above (equal to or lower than 59 mg/kg bw/d).

 

2,4-dichlorprop-P

0.03

6

8 Dec 2006

18-month mouse dietary study, based on an increased incidence of chronic nephropathy observed in male mice at the next highest dose and above (greater than of equal to 59 mg/kg bw/d.

 

Dichlorvos

0.001

0.014 (H)

6 Apr 2004

28-day human study; based on plasma ChE inhibition at and above 0.021 mg/kg bw/d.

 

Dichlozoline

0.001

2.5

7 Dec 1971

 

 

Diclazuril

0.03

3

5 Dec 1990

 

 

Diclobutrazol

0.03

2.5

3 Aug 1984

 

 

Diclofop-methyl

0.002

0.25

6 Feb 1986

 

 Top of page

Dicloran

0.07

7.5 (H)

16 May 1975

 

 

Dicofol

0.001

0.12

5 Dec 1990

 

 

Dicyclanil

0.007

0.7

14 Oct 2005

A 12-month dog dietary study, based on increased plasma cholesterol levels at 4.4 mg/kg plasma cholesterol in a 3-month dog dietary study.

Increased cholesterol was reversible during recovery and was supported by consistent findings of increased plasma cholesterol in a 3-month dog dietary study

Didecyldimethylammonium chloride

0.01

1

25 Jun 1999

Developmental gavage study in rabbits; based on clinical signs observed at the next highest dose of 3 mg/kg/day.

 

Dieldrin

0.0001 (TDI)

JMPR'94

21 Oct 2003

 

Tolerable daily intake. Traditional ADI not maintained as dieldrin is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. end-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Diethofencarb

0.004

7.25

12 Nov 1987

 

 

Difenoconazole

0.01

1

5 Dec 1990

 

 

Difethialone

0.0000006

0.00125

19 Jul 1993

 

 

Diflubenzuron

0.02

2

14 Feb 1985

 

 

Diflufenican

0.2

16.3

11 Aug 1988

 

 Top of page

Dimethenamid-P

0.03

5 [LOEL]

12 Aug 2003

2-year dietary study in rats; based on a LOEL of 100 ppm / 5.1 mg/kg bw/d due to increased incidences of parathyroid hyperplasia at all dose levels.

A NOEL was not established due to parathyroid hyperplasia at the lowest dose tested.

Dimethipin

0.02

2.5

2 Jun 1988

 

 

Dimethirimol

0.2

18

22 Feb 1972

 

 

Dimethoate

0.02

0.2 (H)

10 Feb 1988

 

 

Dimethomorph

0.06

6

12 Jul 1996

2-generation rat reproduction study; a NOEL of 100 ppm (6 mg/kg bw/day) was based on reduced female weight gain at the next highest dose of 300 ppm.

 

Dimetridazole

deleted

 

3 Sep 2003

 

 

Diniconazole

0.002

0.4

17 Aug 1989

 

 

Dinitramine

0.1

15

9 May 1974

 

 

Dinocap

0.001

0.5

15 Jan 1993

 

 

Dinoprost

0.0005

1

17 Mar 1976

 

 Top of page

Diofenolan

0.003

5.6

20 Jul 1995

12-month dog dietary study; a NOEL of 200 ppm (5.6 mg/kg bw/d) was based on decreased plasma bilirubin levels and increased plasma urea and creatine at the next highest dose of 1000 ppm.

High safety factor due to lack of lifetime and reproduction studies.

Dioxathion

deleted

 

21 Oct 2003

 

There is no justification to retain an ADI for dioxathion.

Diphacinone

not necessary

 

4 Feb 2005

 

ADI not necessary; given the non- food use of the chemical.

Diphenamid

0.1

10

9 Aug 1973

 

 

Diphenyl

deleted

 

21 Oct 2003

 

There is no justification to retain an ADI for diphenyl.

Diphenylamine

0.02

1.5

2 Jun 1988

 

 

Diquat

0.002

0.2

28 May 2002

 2-year rat dietary study; based on lenticular cataract formation at and above 15 ppm.

 

Disulfoton

0.001

0.01

1 Dec 1969

 

 

Dithianon

0.007

0.66

2 Feb 1993

 

 

Dithiopyr

0.005

0.5

13 Aug 1992

 

 

Diuron

0.007

0.7

4 Feb 2005

6-month rat dietary study; based on reduced haemoglobin concentrations and increased reticulocytes at the next highest

 

Dodecylbenzene sulfonic acid

0.25

25

9 Jul 1998

2-year dog dietary study, based on liver degeneration at the next highest dose of 125 mg/kg bw/day.

 

Dodine

0.1

10

26 Nov 2002

52-week oral dog study; based on increased diarrhoea, reduced food intake and body weight loss at the next highest dose of 20 mg/kg

 Top of page

Doramectin

0.001

0.1

14 Oct 2002

3-month gavage dog study; based on mydriasis exhibited at the next highest dose of 0.3 mg/kg/d.

 

Doxycycline hyclate

0.005

10

7 Jun 1978

 

 

2,2-DPA

0.2

15

17 Nov 1989

 

 

DSMA

0.0005

0.5

10 Nov 1994

 

 

e

 

 

 

 

 

Efrotomycin

0.5

50

26 Sep 1989

 

 

Emamectin

0.002

0.25

26 Feb 1999

 

 

Endosulfan

0.006

0.6

16 May 1997

78-week dietary study in mice, 13- week dietary study in rats, 1-year dietary study in dogs, developmental study in rats.

 

Endothal

0.03

3.75

5 Dec 1990

 

 

Endrin

0.0002 (TDI)

JMPR'94

21 Oct 2003

 

Tolerable daily intake. Traditional ADI not maintained as endrin is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. end-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Enterococcus faecium

not necessary

 

4 Sep 2002

 

ADI not necessary; not for use in the manufacture of food for human consumption.

Epoxiconazole

0.01

1

16 Apr 2002

12-month dog dietary study; based on the absence of treatment related effects at the highest dose of 40 ppm (1.1 mg/kg/day) weights at the next highest dose of 200 ppm.

Supported by a 78-week rat dietary study; a NOEL of 5 ppm (0.81 mg/kg bw/d) was based on reduced body weight gain and increased liver

Eprinomectin

0.005

1

13 Oct 1997

2-generation dietary reproduction rat study and 53-week gavage dog study; a NOEL of 6 ppm (1 mg/kg/day) was based on tremors in rat pups at the next highest dose of 18 ppm, and mydriasis and neuronal degeneration in the brain in dogs at the next highest dose of 2 mg/kg

 Top of page

EPTC

0.09

9

12 Jan 1995

2-year oral rat study; based on clinical and pathological effects indicative of neuromuscular toxicity at the next highest dose of 18 mg/kg/d.

 

Esbiothrin

0.03

3

15 Sep 1993

 

 

Esfenvalerate

0.008

7.5

17 Mar 1993

 

 

Etaconazole

0.05

5

3 Aug 1984

 

 

Ethametsulfuron-methyl

0.2

21

17 Jan 2001

2-year rat feeding study. A NOEL of 500 ppm (21 mg/kg bw/day) was based on reduced serum sodium levels in both sexes and enlarged mammary glands in females at the next highest dose of 5000 ppm.

 

1,2-Ethanediamine polymer with (chloromethyl) oxirane and N-methylmethanamine

not necessary

 

9 Dec 2003

 

ADI not necessary; as it is not intended for use in food production.

Ethephon

0.02

0.17(H)

18 Feb 1987

 

 

Ethion

0.001

0.1

10 Jun 1987

 

 

Ethofumesate

0.3

30

11 Nov 1976

 

 Top of page

Ethoprophos

0.0003

0.03

11 Aug 1988

 

 

Ethoxyquin

0.001

2.5 [LOEL]

21 Feb 2000

Reproduction study in dogs; based on clinical signs and histological changes in the liver at the LOEL of 100 ppm (2.5 mg/kg bw/d).

ADI is based on the 1998 JMPR evaluation but with the application of additional safety factors due to inadequate data and the lack of a clear NOEL in any suitable study.

Ethoxysulfuron

0.06

6.2

12 May 2004

3-month dietary dog study (1993); NOEL (200 ppm in the diet) based on thyroid follicular hyperplasia and increased thyroid weight at 14 mg/kg bw/d (400 ppm) in another 3-month dog dietary study (1991).

 

Ethyl formate

3

 

26 Nov 2003

2 generation rat reproduction study. Rats dosed with 0.4% (approximately equivalent to 300-400 mg/kg/day) calcium formate in drinking water, with no treatment related findings resulting. findings related was considered

No oral repeat dose studies were appropriate for setting an ADI. Formic acid is likely to produce toxic effects in humans, so the 2- generation reproduction study in rats where no treatment-related

Etofenprox

0.03

3.1

15 Dec 1993

 

 

Etoxazole

0.04

4

17 Dec 2003

2-year rat study and a 12-month dog study, based on liver toxicity at the next highest dose of 16 mg/kg/d in male rats, and increased liver weights and hepatocellular swelling at the next highest dose of 23.5 mg/kg/d in male dogs.

The NOELs for the rat and dog studies were 4 and 4.6 mg/kg/d, respectively (in males).

Etridiazole

0.03

3

30 Aug 1991

 

 

Etrimfos

0.001

0.1

2 May 1985

 

 

f

 

 

 

 

 

Famphur

0.00002

0.0375

4 Mar 1975

 

 

Febantel

0.02

2

15 Jul 1996

2-generation developmental rat study; a NOEL of 20 ppm (2 mg/kg bw/day) was based on changes in hepatic morphology in parental animals and pups at the next highest dose of 100 ppm.

 

Fenamiphos

0.0001

0.014

7 Nov 2005

Inhibition of plasma ChE activity in a 2-year dog study at the next highest dose of 0.036 mg/kg bw/d

Supported by a NOEL of 0.011 mg/kg bw/d for plasma ChE inhibition in a 6-month dog study.

Fenarimol

0.01

1

5 Dec 1990

 

 

Fenazaflor

0.02

2.5

8 Dec 1970

 

 

Fenbendazole

0.05

5

14 Feb 1991

 

 

Fenbutatin-oxide

0.01

1

10 Sep 1987

 

 Top of page

Fenchlorphos

deleted

 

21 Oct 2003

 

There is no justification to retain an ADI for fenchlorphos

Fenfuram

0.1

10

16 Jun 1986

 

 

Fenhexamide

0.2

17.4

16 Dec 1998

12-month dog dietary study; a NOEL of 500 ppm (17.4 mg/kg bw/day) was based on increased adrenal weight parameters, the presence of intracytoplasmic vacuoles in the adrenal cortex, and alterations in RBC, Hb and Hct at the next highest dose of 3500 ppm.

 

Fenitrothion

0.002

0.2

6 Nov 1997

Dog 1-year dietary study; based on plasma ChE inhibition. LOEL for erythrocyte ChE was 1.6 mg/kg bw/d.

 

Fenoxaprop-ethyl

0.004

0.4

14 Feb 1991

 

 

Fenoxycarb

0.05

5

29 Oct 1998

18-month mouse dietary mouse study; a NOEL of 50 ppm (5 mg/kg//day) was based on increased liver weight, increased incidence of pulmonary tumours and decreased body weight at the next highest dose of 500 ppm.

 

Fenpiclonil

0.01

1.2

20 Jun 1991

 

 

Fenpyroximate

0.005

0.5

24 May 1993

 

 

Fensulfothion

0.003

0.025

15 Feb 1973

 

 

Fenthion

0.002

0.02 (H)

30 Apr 2004

28-day human study; based on plasma and ChE inhibition at 0.07 mg/kg bw/d, the highest dose tested.

 

Fentin

deleted

 

21 Oct 2003

 

There is no justification to retain an ADI for fentin.

Fenvalerate

0.02

1.7

10 Jun 1987

 

 Top of page

Fipronil

0.0002

0.02

27 Jun 1994

Chronic/carcinogenicity dietary study of fipronil in rats, based on clinical signs of neurotoxicity, increased thyroid weight, decreased T4 levels, and increased severity of progressive senile nephropathy at the next highest dose of 0.06 mg/kg

This is a group value to cover fipronil, desulfinyl fipronil, fipronil suphide and fipronil sulphone.

Firocoxib

not necessary

 

1 Sep 2004

 

ADI not necessary; not for use in food-producing animals.

Flamprop-methyl

0.001

0.125

29 Aug 1991

 

 

Flavophospholipol

0.3

 

14 Sep 2001

 

see: Bambermycin

Flocoumafen

0.000001

0.0014

20 Sep 1995

90-day repeat dose study in rats; a NOEL of 0.02 ppm (0.0014 mg/kg bw) was based on increased levels of serum cholesterol at the next highest dose of 0.05 ppm.

Large safety factor due to lack of chronic study.

Florasulam

0.05

5

20 Dec 2007

1-year dietary study in dogs, based on histopathological findings in the kidneys in both sexes at the next highest dose of 50 mg/kg bw/d (Stebbins & Haut, 1997). This NOEL selection is supported by a shorter 3-month dietary study in dogs with the same endpoint and NOEL of 5 mg/kg bw/d (Stebbins, 1995).

The effect of florasulam in mammals was an increased incidence and severity of a histopathological lesion classified as hypertrophy of type-A epithelial cells lining the collecting ducts of the kidney.

Florfenicol

0.001

1

3 Aug 2001

12-month oral dog study; based on increased liver weight and cystic epithelial hyperplasia of the gall bladder at the next highest dose of 3 mg/kg bw/d.

High safety factor due to the absence of a NOEL in a two-year dietary rat study (LOEL 3 mg/kg

Fluazifop-butyl

0.003

0.3

5 Aug 1982

 

 

Fluazinam

0.004

0.4

18 Jun 1993

 

 

Fluazuron

0.04

4.27

14 Sep 1993

 

 Top of page

Flubendiamide

0.01 mg/kg bw

1.0

14 Dec 2007

1-year rat study, based on hepatoxicity and microcytic anaemia at the nex highest dose of 2.4 mg/kg bw/d.

1 mg/kg bw/d = 20 ppm
2.4 mg/kg bw/d = 50 ppm

Fluchloralin

0.003

5.25

15 Nov 1973

 

 

Flucythrinate

0.02

1.6

11 Mar 1994

 

 

Fludioxonil

0.03

3.1

23 Apr 1997

2- year rat study and 52-week dog dietary study; a NOEL of 100 ppm (3.7 mg/kg bw/d in rats and 3.1 mg/kg bw/d in dogs) was based on clinical signs, discoloured urine and reduced body weight gain in rats and blue faeces, discoloured digestive tract and reduced body weight gain in dogs at the next highest dose of 1000 ppm

 

Flufenoxuron

0.02

2.5

21 Jan 1997

12-month dog dietary study; a NOEL of 100 ppm (2.5 mg/kg bw/d) was based on haemolytic anaemia and microscopic liver pathology at the next highest dose of 500 ppm.

 

Flugestone acetate

0.0001

0.2

19 Feb 1981

 

 

Flumethrin

0.003

0.31

18 Oct 2001

2-generation rat reproduction study; a NOEL of 5 ppm (0.25 mg/kg bw/day in males, 0.31 mg/kg bw/day in females) was based on clinical signs, reduced food consumption and reduced body weight gain (parental effects) and decreased birth weight, pup survival and weight gain (reproductive effects) at the next highest dose of 50 ppm.

 

Flumetsulam

1

100

14 Feb 1992

 

 

Flumiclorac pentyl

0.30

32

8 Dec 2004

18-month study in mice; a NOEL of 300 ppm (32 mg/kg bw/d) was based on haematological changes, weight and histopathological changes in the liver in males 3000 ppm and

 

Flumioxazin

0.003

3

12 Dec 2002

Developmental oral rat study; based on increased incidence of cardiovascular abnormalities at the next highest dose of 10 mg/kg

High safety factor due to nature and irreversibility of treatment related effects.

Flunixin meglumine

0.006

0.6

29 Sep 2000

2-year oncogenicity study in mice; based on higher incidences of haematopoiesis in the liver and kidney at the next highest dose of 2 mg/kg/day.

 

Fluometuron

0.02

2

16 Feb 1989

 

 

Flupropanate

0.002

5

10 Sep 1987

 

 Top of page

Fluquinconazole

0.005

0.5

2 Jul 1997

2-year rat study and a 1-year dog study; a NOEL of 10 ppm (0.5 mg/kg bw/d) was based on mortality, elevated food and water consumption, reduced body weight gains and increased relative organ weights in rats at the next highest dose of 100 ppm, and clinical signs in dogs at the next highest dose of 15 mg/kg bw/d

 

Fluroxypyr

0.2

20

6 Feb 1986

 

 

Flusilazole

0.002

0.2

18 Feb 1987

 

 

Flutolanil

0.02

2

16 Oct 2001

24-month rat dietary study; a NOEL of 40 ppm (2 mg/kg bw/day) was based on an increased albumin:globulin ratio in males, and reduced bilirubin and dilation of the sinusoid in the liver in females at the next highest dose of 200 ppm.

 

Flutriafol

0.01

1

20 Jun 1991

 

 

Fluvalinate

0.005

0.5

5 Nov 1986

 

 

Fluxofenim

0.0005

1

9 Aug 1994

 

 

Forchlorfenuron

0.07

7

15 Apr 2005

2-year rat study; A NOEL of 150 ppm (7 mg/kg bw) was based on macroscopic and microscopic lesions in the kidneys at the next highest dose of 2000 ppm.

 

Formetanate

0.004

0.37

25 Oct 1993

 

 

Formothion

deleted

 

21 Oct 2003

 

There is no justification to retain an ADI for formothion.

Fosamine

0.01

25

2 Jun 1988

 

 

Fosetyl aluminium

1

103

18 Feb 1987

 

 

 
     Top of page

Furathiocarb

0.003

0.35

20 Jun 1991

 

 

Furazolidone

deleted

 

2 Dec 2003

 

Use of furazolidone in food- producing animals has been withdrawn. Therefore, an ADI for this compound is not necessary.

g

 

 

 

 

 

Gentamicin

0.05

5

6 May 1983

 

 

Gibberellic acid

5

550

13 Jan 1993

 

 

Glufosinate

0.007

0.67

11 Aug 1988

 

 

Glufosinate ammonium

0.02

2.1

28 Aug 2001

2 1/2 year rat dietary study; based on inhibition of glutamine synthetase activity in the liver and brain, and decreased glutathione levels in the liver and blood.

 

Glyoxime

0.001

0.1

7 May 1981

 

 

Glyphosate

0.3

30

14 Feb 1985

 

 

 
     

Guazatine

0.006

0.625

25 Mar 1997

52-week dog dietary study; a NOEL of 25ppm (0.625 mg/kg bw/day) was based on reduced body weight gains and food consumption in females at the next highest dose of

 

h

 

 

 

 

 

Halofuginone

0.0003

0.025

16 Jun 2006

The ADI was set from a rabbit development study in which the NOEL was 0.025 mg halofuginone base/kg bw/d. The LOEL, 0.075 mg halofuginone base/kg bw/d, was also the highest dose tested. Maternotoxic effects noted at this dose included: lowered body weight gain and food consumption, mortality and abortions. No direct consequences on the embryofoetal development were noted.

The rabbit was the most sensitive species.

Halosulfuron-methyl

0.01

1

19 Nov 1993

 

 Top of page

Haloxyfop

0.0003

0.03

12 Nov 1987

 

 

Heptachlor

0.0005 (TDI)

JMPR'94

21 Oct 2003

 

Tolerable daily intake. Traditional ADI not maintained as heptachlor is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. end-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Hexaconazole

0.005

0.5

17 May 1990

 

 

Hexaflumuron

0.02

2

31 Aug 2001

 

 

Hexaflurate

0.01

25

16 May 1975

 

 

Hexazinone

0.1

10

12 Nov 1987

 

 

Hexythiazox

0.03

3

29 May 1986

 

 

Hydroprene

0.5

50

28 Oct 1994

 

 

i

 

 

 

 

 

Imazalil

0.03

2.5

24 Jul 1997

12-month dog study; based on decreased body weights, and increased relative liver weights, serum AP and GGT levels at the next highest dose of 20 mg/kg bw/day.

 

Imazamox

2.8

282

11 Mar 1999

1-year dog dietary study; a NOEL of 10,000 ppm (282 mg/kg//day) was based on elevated CPK at the next highest dose of 40,000 ppm.

 Top of page

Imazapic

0.3

137

17 May 1996

1-year dog dietary study; a NOEL of 5000 ppm (137 mg/kg/day) was based on reduced haematocrit, haemoglobin and RBC levels at the next highest dose of 20,000 ppm.

 

Imazapyr

2.5

250

2 Jun 1998

12-month dog dietary study; based on the absence of signs of toxicity at the highest dose of 10,000 ppm (250 mg/kg/day).

 

Imazaquin

0.25

25

18 Feb 1987

 

 

Imazethapyr

2.8

276

22 Feb 1990

 

 

Imidacloprid

0.06

6

8 Feb 1993

 

 

Imidocarb

0.05

5

16 Aug 1979

 

 

Iminoctadine trialbesilate

0.004

0.4

22 Dec 2004

52-week dietary study in dogs; based on reduced epididymus weight and increased prostate weight in males, and an increased incidence of kidney histopathology in both sexes at the next highest dose of 0.9 mg/kg bw/day.

 

Imiprothrin

0.05

5

30 Sep 1996

12-month oral dog study; based on increased salivation and liquid faeces and increased microscopic pathology in the liver, at the next highest dose of 50mg/kg bw/day.

 

Indoxacarb

0.01

1

21 Aug 2006

1-year dog study (NOEL = 1.1 mg/kg bw/d) bw/d) and (2) Two-generation rat dietary study (NOEL = 1.25 mg/kg bw/d).

Also supported by; (1) 2-year rat dietary study (NOEL = 1.04 mg/kg bw/d) and (2) Two-generation rat dietary study (NOEL = 1.25 mg/kg bw/d).

Iodofenphos

0.0002

0.34

9 May 1974

 

 

Iodosulfuron-methyl-sodium

0.03

3

29 Sep 2000

2-year rat dietary study; a NOEL of 70 ppm (3 mg/kg bw/day) was based on reduced bodyweight gains at the next highest dose of 700 ppm.

 

Ioxynil

0.004

0.04

18 Feb 1987

 

 Top of page

Iprodione

0.04

4

16 Jun 1986

 

 

Isocarbophos

0.0002

0.03

16 May 1975

 

 

Isoeugenol

0.2

500

20 Aug 1996

16-week dietary rat study; based on the absence of signs of toxicity at the highest dose of 10000 ppm (500 mg/kg bw/day).

High safety factor due to lack of developmental and reproductive studies, lack of direct data, and the inadequacy of the study from which the NOEL must be set.

Isofenphos

0.0005

0.05

10 Feb 1988

 

 

Isoxaben

0.05

5

9 Aug 1995

2-year dietary rat study; based on renal pathology at the next highest dose of 51 mg/kg bw/d.

 

Isoxaflutole

0.02

2

6 May 1997

2-year rat dietary study; based on histological alterations of the liver, nerves and skeletal muscle, and cornea effects at the next highest dose of 20 mg/kg/day.

Supported by a 2-generation rat reproduction study; a NOEL of 2 mg/kg bw/day for maternal and pup toxicity was based on increased liver weights and altered liver histology, and reduced pup viability at the next highest dose of 200 mg/kg bw/day.

Ivermectin

0.001

0.1

16 Oct 1998

Mouse developmental study; based on maternotoxicity at the next highest dose of  0.2 mg/kg bw.

 

k

 

 

 

 

 

Ketoprofen

0.001

0.1

8 Dec 2000

 

 

Kitasamycin

0.5

1000

22 Mar 1979

 

 

Krenite

0.5

1000

5 Aug 1976

 

 

Kresoxim-methyl

0.4

36

25 Jun 1999

24-month oral rat study; a NOEL of 800 ppm (36 mg/kg bw/day) was based on lower body weight, increased liver weight, elevated enzyme activity and liver changes at the next highest dose of 8000 ppm.

 Top of page

l

 

 

 

 

 

Lactobacillus acidophilus

not necessary

 

 

4 Sep 2002

ADI not necessary.

Lactobacillus brevis

not necessary

 

 

4 Sep 2002

ADI not necessary.

Lactobacillus casei

not necessary

 

 

4 Sep 2002

ADI not necessary.

Lactobacillus plantarum

not necessary

 

 

4 Sep 2002

ADI not necessary.

Laidlomycin

0.001

2

2 Dec 1988

 

 

Lambdacyhalothrin

0.001

0.1

5 Dec 1990

 

 

Lasalocid

0.001

2

9 Feb 1977

 

 

Lenacil

0.13

12.5

7 Dec 1972

 

 

Leptophos

0.005

0.5

7 Dec 1972

 

 

Levamisole

0.003

6

14 Nov 1974

 

 Top of page;

Lignocaine

 

 

Lincomycin

0.009

 

 

1

8.57

 

 

100

10 June 2008

 

 

5 Aug 1983

In human cardiac treatment, doses of 1-10 mg/kg are used. If 1 mg/kg bw is taken as a dose without adverse effects, and 35% bioavailability is assumed via the oral route, the corresponding oral dose can be estimated to be 3/0.35 =8.57 mg/kg bw. An ADI of 0.009 mg/kg bw was derived by applying a 1000-fold safety factor.

A 1000-fold safety factor was applied to the LOEL, taking into account that 8.57 mg/kg bw represents a LOEL at the low end of the therapeutic range (10-fold), intraspecies variability (10-fold) and uncertainties due to an inadequate toxicological database (10-fold).

Lindane

0.003

0.31

5 Nov 1986

 

 

Linuron

0.01

1.25

11 Sep 1986

 

 

Lufenuron

0.02

2.1

4 Mar 1994

 

 

Lysocellin sodium

0.002

3

14 Feb 1992

 

 

 

m

 

 

 

 

 

Maduramicin

0.001

0.1

5 Nov 1986

 

 

Maldison

0.02

2

12 Apr 2005

2-year rat study; based on inhibition of RBC cholinesterase activity at higher doses.

The LOEL in the rat study was 29 mg/kg bw/d.

Maleic hydrazide

5

571

5 Jan 1993

 

 

Mancozeb

0.006

0.6

27 Nov 1992

 

 

MCPA

0.01

1.1

28 Apr 1994

 

 

MCPB

0.01

1.1

12 May 1994

 

 

Mebendazole

0.08

8

14 Feb 1975

 

 

Mecoprop

0.01

1

3 Jul 1998

 

 Top of page

Mecoprop-P

0.04

4

17 Jan 2001

18-month dietary study in mice. A NOEL of 25 ppm (4 mg/kg/day) was based on increased kidney weights and chronic nephropathy in females at the next highest dose of 250 ppm.

 

Mefenpyr-diethyl

0.03

2.8

13 May 1997

87-week oral mouse study; a NOEL of 20 ppm (2.8 mg/kg/d) was based on hepatocellular hypertrophy in males at the next highest dose of 100 ppm.

 

Mefluidide

0.25

25

1 Dec 1988

 

 

Melengestrol acetate

0.00005

0.005

6 Jan 2000

Chronic oral study in monkeys. A hormonal NOEL of 5 ug/kg/day (0.005 mg/kg/day) was based on changes in hormonal and menstrual cycle variables at the next highest dose of 10 ug/kg/day.

 

Meloxicam

0.0001

0.125 [LOEL]

5 Feb 1999

Gavage rat peri- and postnatal study; based on clinical signs, longer gestation and partuition, and decrease in the number of live pups and pup viability at the LOEL of 0.125 mg/kg bw from day 17 of gestation to day 21 of lactation.

High safety factor due to use of LOEL.

Mepiquat

0.15

15

30 Aug 1991

 

 

Mesosulfuron-methyl

1

100

27 May 2002

 

 

Metalaxyl

0.03

3

7 May 1981

 

 

Metaldehyde

0.005

5

11 Sep 1986

 

 

Metarhizium Anisopliae var. Acridum (isolate FI-985)

not established

 

4 Sep 2003

 

ADI not established; due to inadequate data.

Methabenzthiazuron

0.004

7.5

22 Jul 1969

 

 

Methacrifos

0.007

0.07

10 Jun 1987

 

 Top of page

Methamidophos

0.0003

0.03

30 Jan 2004

Rat 8-week dietary study; based on plasma, erythrocyte and brain ChE inhibition at the next highest dose of 0.06 mg/kg bw/d.

 

Methazole

0.0004

0.75

10 Feb 1988

 

 

Methfuroxam

0.002

3

10 Nov 1977

 

 

Methidathion

0.002

0.16

31 May 2004

90-day dog dietary studies; NOEL (0.16 mg/kg bw/d) based on evidence of liver cholestasis and inhibition of RBC ChE activity at the next highest dose of 1.96 mg/kg

 

Methiocarb

0.002

0.2

1 Mar 2000

2-year dog study; based on plasma ChE depression and reduced food consumption observed at the next highest dose of 9.6 mg/kg bw/day and sexes and reduced food consumption in females observed at the next highest dose of 2.4 mg/kg

 

Methomyl

0.01

1.25

14 Feb 1991

 

 

Methoprene

0.4

35

14 Jan 2000

18-month study in mice; a NOEL of 250 ppm (35 mg/kg bw/day) was based on deposition of pigmentation in the liver at the next highest dose of 1000 ppm.

 

Methoxychlor

0.1 (TDI)

JMPR'94

21 Oct 2003

 

Tolerable daily intake. Traditional ADI not maintained as methoxychlor is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. end-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Methoxyfenozide

0.1

10

12 Jan 2001

89-99 week rat dietary study and 52- week dog dietary study; a NOEL of 200 ppm (10 mg/kg bw/day) was based on reduced erythrocyte, haemoglobin and haematocrit levels and increased liver weights in rats at the next highest dose of 8000 ppm, and increases in methaemoglobin and platelet count and decreases in erythrocyte, haemoglobin and haematocrit levels in dogs at the next highest level of 300 ppm.

 

Methyl benzoquat

0.05

100

10 Nov 1977

 

 

Methyl bromide

0.0004

0.4

14 Sep 2001

90-day rat gavage study; based on clinical signs at the next highest dose of 2 mg/kg b/w day.

 

1-Methylcyclopropene

not established

 

10 Oct 2003

 

There was insufficient information to establish an ADI, however, based on its proposed pattern of use the dietary intake is likely to be low.

Methylisothiocyanate

0.0004

0.04

26 Feb 2004

3-month dog study; based on decreased testis weight, increased pancreas weight and abnormal liver histology at 2 mg/kg/d.

 Top of page

Metiram

0.02

5

10 Feb 1988

 

 

Metobromuron

0.001

2.5

4 Mar 1971

 

 

Metolachlor

0.08

7.5

12 Nov 1987

 

 

Metosulam

0.05

5

18 Jan 1993

 

 

Metribuzin

0.02

2

4 Nov 1982

 

 

Metsulfuron-methyl

0.01

1

1 Aug 1985

 

 

Mevinphos

0.002

0.015 (H)

29 Oct 1998

Human study; safety factor reflects concerns over the nerve conduction effects. LOEL 0.025.

 

Molinate

0.002

0.2

5 Nov 1986

 

 

Monensin

0.01

1.25

10 Nov 1977

 

 

Monocrotophos

0.0003

0.0036

11 Jun 1998

28-day human oral study; based on plasma ChE inhibition at the next highest dose of 0.0057 mg/kg

 Top of page

Morantel

0.01

1.2

26 Nov 2002

2-year dietary study in rats and 2- year oral toxicity study in dogs; based on reduced body weight gain, food consumption and food conversion efficiency in rats at the next highest dose of 20 mg/kg/day, and increased adrenal and liver weights in dogs at the next highest dose of 20mg/kg/day

The NOEL in both studies was 2 mg/kg/day of morantel tartrate, which is the equivalent to 1.2 mg/kg/bw of morantel.

Moxidectin

0.01

1

7 Jun 2004

90-day and 1 year dog studies, and a rabbit developmental study; based on no observed effects at 1.12 mg/kg bw/d in the 1 year dog study, and maternal toxicity at the next highest dose of 5 mg/kg/d in rabbits. The 90- day dog study had a NOEL of 0.3 mg/kg/d, based on reduced weight gain at 0.9 mg/kg/d, and signs of neurotoxicity were observed at 1.6 mg/kg/day (no testicular or sperm effects).

The endpoints setting the LOEL in the 90-day dog study (reduced body weight gains in males at 0.9 mg/kg bw) were not observed in a 1 year dog study utilising larger group sizes at 1.12 mg/kg bw/d, suggesting that the reduction in body weight gains in males in the 90-d study may be incidental to treatment and therefore not an appropriate end- point for establishing an overall NOEL.
New information did not indicate a need to alter the existing ADI, set in April 2004.

MSMA

0.0005

0.5

10 Nov 1994

 

 

Myclobutanil

0.03

2.6

12 Nov 1987

 

 

n

 

 

 

 

 

Naled

0.002

0.2

18 Feb 1987

 

 

Naphthalophos

0.0001

0.25

7 Dec 1971

 

 

Napropamide

0.1

11

29 Jul 1994

 

 

Narasin

0.01

1.5

5 Aug 1983

 

 

Neem Limonoids

not established

 

28 May 2004

 

ADI not established; due to insufficient information.

Neomycin

0.06

6 (JECFA’96)

28 Feb 1996

Guinea pig study.

 

Netobimin

0.004

7.6

10 Feb 1988

 

 

Nicarbazin

2

240

4 Nov 1982

 

 

Nifursol

deleted

 

2 Dec 2003

 

Use of nifursol in food-producing animals has been withdrawn. Therefore, an ADI for this compound is not necessary.

Nimidane

0.001

25

18 Mar 1976

 

 Top of page

Nithiamide

0.005

10

18 Mar 1976

 

 

Nitralin

0.24

24

9 Aug 1972

 

 

Nitrothal-isopropyl

0.05

5

19 Feb 1981

 

 

Naptalam

0.065

6.5

4 Feb 1982

 

 

Nitrovin

0.006

12.5

12 Nov 1981

 

 

Nitroxynil

0.02

2

20 Aug 1974

 

 

Norflurazon

0.02

1.5

1 Nov 1984

 

 

Norgestomet

0.0000005

0.001

5 Dec 1985

 

 

Novaluron

0.01

1.1

17 Jan 2001

2-year rat dietary study; a NOEL of 25 ppm (1.1 mg/kg bw/day) was based on haematological and histopathological changes at the next highest dose of 700 ppm.

 

Nuclear polyhedrosis virus of helicoverpa armigera occlusion bodies

not necessary

 

17 Dec 2003

 

ADI not necessary; as available evidence suggests it is unlikely to be a chronic toxin or pathogenic in humans.

o

 

 

 

 

 

Octadecenoic acid methylester

not necessary

 

30 Oct 2000

 

ADI not necessary.

Octenol

not necessary

 

15 Nov 2004

 

ADI not necessary; not intended to be used in food commodities.

Octhilinone

0.03

60

18 May 1977

 

 Top of page

n-Octyl bicycloheptene dicarboximide

0.07

7.5

25 May 1995

 

 

Oestriol

not necessary

 

5 Feb 2004

 

ADI not necessary; as it is not intended to be used in food production.

Ofurace

0.0007

1.3

10 Jun 1987

 

 

Olaquindox

0.06

6

7 May 1981

 

 

N-oleyl-1,3-diaminopropane

not necessary

 

10 Dec 2003

 

ADI not necessary; as it will not result in human exposure via the diet.

Omethoate

0.0004

0.04

20 Oct 2005

A 2 year rat dietary study, based on inhibition of cholinesterase activity at 0.13 mg/kg bw/d and above.

Supported by similar NOELs in a 2 year drinking water study in rats, a 1 year gavage study in dogs, and a 2- generation reproduction study in

ortho-Phenylphenol

0.4

JMPR'99

21 Oct 2003

 

 

Oryzalin

0.1

12

5 May 1982

 

 

Oxabetrinil

0.005

10

2 May 1985

 

 

Oxadiargyl

0.008

0.8

28 Jun 1999

2-year dietary rat study; a NOEL of 20 ppm (0.8 mg/kg bw/d) was based on histopathological changes in the liver and kidneys at the next highest dose of 500 ppm.

 

Oxadiazon

0.05

5

17 Aug 1989

 

 

Oxadixyl

0.01

1.3

2 Jun 1988

 

 Top of page

Oxamyl

0.002

0.2

18 May 1993

 

 

Oxfendazole

0.005

0.5

8 Oct 1990

 

 

Oxibendazole

0.01

10

2 Jun 1998

3-month oral toxicity study in dogs (capsules); based on reduced food consumption in males, and reduced body weight gains in both sexes, and reduced testes weights at the next highest dose of 30 mg/kg bw/d.

High safety factor due to incomplete study database.

Oxycarboxin

0.15

15

15 Aug 1979

 

 

Oxyclozanide

0.002

5

18 Mar 1976

 

 

Oxydemeton-methyl

0.0003

0.027

16 Dec 1997

2-year feeding study in rats; a NOEL of 1 ppm (0.027 mg/kg bw/d) was based on inhibition of plasma and erythrocyte cholinesterase levels at the next highest dose of 10 ppm.

 

Oxyfluorfen

0.025

2.5

5 Aug 1982

 

 

Oxytetracycline

0.03

JECFA'98

21 Oct 2003

 

 

Oxythioquinox

0.006

0.6

11 Sep 1986

 

 

p

 

 

 

 

 

Paclobutrazol

0.01

1.4

10 Feb 1988

 

 

Paraquat (as cation)

0.004

0.45

27 Jun 2003

1-year dog study; based on pulmonary lesions at the next highest dose of 0.9 mg/kg bw/d (males), and above.

 Top of page

Parathion

0.005

0.05 (H)

4 Jun 1997

3-week oral study in human volunteers; based on erythrocyte cholinesterase inhibition.

 

Parathion-methyl

0.0002

0.02

11 Jun 1997

12-month rat dietary study; based on neuropathological effects.

 

Pebulate

0.007

0.7

5 Dec 1990

 

 

Penconazole

0.007

0.71

6 Feb 1986

 

 

Pencycuron

0.02

2

23 May 1994

 

 

Pendimethalin

0.1

12

18 Feb 1987

 

 

Perfluidone

0.003

5

9 Feb 1977

 

 

Permethrin

0.05

5

29 May 1986

 

 

Phenisopham

0.0003

0.5

16 Aug 1978

 

 

Phenmedipham

0.01

1.5

20 Jun 1991

 

 

Phenothrin

0.02

2.5

10 Feb 1988

 

 

Phorate

0.0005

0.05

30 Aug 1991

 

 

Phosalone

0.006

0.625

19 Feb 1969

 

 Top of page

Phosmet

0.01

1

12 Nov 1987

 

 

Phosphamidon

deleted

 

21 Oct 2003

 

There is no justification for an ADI for phosphamidon.

 

 

 

 

 

 

Phoxim

0.00025

0.025

22 Feb 1990

 

 

Picloram

0.07

7

18 Feb 1987

 

 

Praziquantel

0.02

20

22 Jun 1995

13-week oral dog study; based on increased relative liver weights of the thyroid at the next highest dose of 60 mg/kg/day.

 

Prochloraz

0.01

1

5 Aug 1982

 

 

Proconazole

0.008

16

14 Aug 1980

 

 

Procymidone

0.03

2.5/3.5

13 Dec 2004

Reproduction and developmental toxicity studies in rats; the NOEL of 2.5 in the reproduction study was based on increased testes weights and decreased weights of epididymides and prostate at 250 and 750 ppm; the NOEL of 3.5 in the developmental toxicity study was based on decreased anogenital distance in male foetuses at the next highest dose of 12.5 mg/kg bw/d.

 

Prodiamine

0.05

5

22 Dec 1994

 

 

Profenofos

0.0001

0.0072

4 Feb 1982

 

 

Profoxydim

0.05

5

29 Nov 2006

24-month rat study, based on decreases in alkaline phosphatase and cholesterol levels and decreases in RBC's, haemoglobin and haematocrit in male rats at the next higher dose of 50 mg/kg bw/d.

The same NOEL (5 mg/kg bw/d) was also obtained in the second 24- month dietary study in rats and in the 12-month dietary study in dogs.

Prohexadione-calcium

0.2

20

20 Dec 2007

2-year rat study and a 12-month dog study, based on abnormal haematology, clinical chemistry and thyroid histopathology and decreased bodyweight gain and food conversion efficiency at the next highest dose of 94 mg/kg bw/d in rats, and abnormal haematology and clinical chemistry and renal histopathology at the next highest dose of 200 mg/kg bw/d in dogs.

The NOELs for the rat and dog studies were 18.5 and 20 mg/kg bw/d, respectively.

Promacyl

0.2

20

18 May 1977

 

 Top of page

Prometryn

0.03

3

17 May 1990

 

 

Propachlor

0.02

2

11 Aug 1988

 

 

Propamocarb

0.1

10

10 Sep 1987

 

 

Propanil

0.2

20

19 Feb 1981

 

 

Propaquizafop

0.003

0.3

26 Nov 1992

 

 

Propargite

0.002

2

17 Jun 1999

20-month dietary rat study; a NOEL of 40 ppm (2 mg/kg/day) was based on a transient cell proliferative response (increased jejunal smooth muscle cells) at the next highest dose of 800 ppm (a dose which induces jejunal tumours).

High safety factor due to the narrow margin between the NOEL and the tumourigenic dose in rats.

Propazine

0.02

1.5

16 Jun 1986

 

 

Propetamphos

0.001

0.1

14 Feb 1985

 

 

Propiconazole

0.04

4

5 May 1983

 

 

Propineb

0.0005

0.05 for PTU

15 Feb 2007

2-year rat study, based on increased cholesterol levels in male rats and increased plasma protein levels in female rats at the next highest dose of 0.5 mg/kg bw/d.

The ADI for propineb should be a group value, which includes propineb and it's impurity/metabolite, propylenethiourea (PTU)

Propionibacterium freudenreichii

not necessary

 

4 Sep 2002

 

ADI not necessary.

Propoxur

0.02

0.2

5 Nov 1986

 

 Top of page

Propylene oxide

0.006

2.9

24 Jul 2006

124 week inhalation study in rats; based on reduced body weight gain and increased mortality at the next highest equivalent oral dose of 9.7 mg/kg bw/d and above.

The ADI was based on route-to- route extrapolation, with equivalent oral doses being derived from inhalation doses. The safety factor included an additional factor of 5 because of the uncertainty associated with the use of route-to-route extrapolation.

Propylene thiourea

0.0005

0.05

2 Dec 1988

 

 

Propyzamide

0.02

1.9

7 Jul 1994

 

 

Prostianol

0.000005

0.01

12 Nov 1981

 

 

Prosulfocarb

0.02

1.9

21 Aug 2006

2-year rat study; based on reduced bodyweight gain at the next dose level of 16.9 mg/kg/d.

The LOELs for reduced bodyweight gain were 5, 9 and 16.9 mg/kg bw/d respectively, in a two-generation reproductive study and 3-month and 2-year feeding studies in rats. The highest NOEL that was lower than any LOEL was 1.9 mg/kg bw/d.

Prothioconazole

0.01

1.1

28 Mar 2006

2-year rat study, based increased liver weight, hepatocellular hypertrophy, and liver vacuolation with fatty change at the next highest dose of 8 mg/kg bw/d in rats.

The NOAEL for the rat study was 1.1 mg/kg bw/d (in males). 0.01 mg/kg bw/d is a group ADI for prothioconazole and prothioconazole-desthio

Prothiofos

0.0001

0.01

29 Oct 1993

 

 

Prynachlor

0.1

7.9

4 Mar 1971

 

 

Pymetrozine

0.006

0.57

8 Dec 2000

 

 

Pyraclofos

0.001

0.1

29 Aug 1991

 

 Top of page

Pyraclostrobin

 

Pyraflufen-ethyl

0.03

 

0.2

3

 

20

26 June 2008

 

17 Dec 2004

24-month rat study, based on reduced body weight gain in males and females at the next highest dose of 9 mg/kg bw/day in rats.
NOELs of around 20 mg/kg bw based on an 18-month and a 24- month study in mice and rats respectively and a developmental study in rabbits. Based on increased liver weight at the next highest dose of 1000 ppm (ca 100mg/kg bw/d) in the mouse study; increased urinary volumes and relative kidney weight , and decreased specific gravity in the urine at the next highest dose of 2000 ppm (ca 100 mg/kg bw/d) in the rat; and increased mortality at the next highest dose of 60 mg/kg bw/d in the rabbit study.

 

Pyrasulfotole

0.01

1

19 Oct 2007

2-year rat study, based on corneal and retinal lesions, increased liver weight, centrilobular hepatocellular hypertrophy, raised plasma cholesterol at 10 mg/kg bw/d.

 

Pyrazophos

0.007

0.07 (H)

29 Aug 1991

 

 

Pyrethrum extract

0.04

JMPR'99

21 Oct 2003

 

 

Pyridaben

0.01

1

13 Aug 1992

 

 

Pyridalyl

0.02

2.8

29 Apr 2004

Rat reproduction study; based on delayed vaginal opening among pups at higher doses, the NOEL was 40 ppm.
A 200-fold safety factor was applied due to the uncertainty relating to extrapolating across species for bioaccumulating compounds, the absence of appropriate steroid concentration monitoring and the likelihood that significant inhibition of 17ß-hydroxysteroid dehydrogenase activity is occurring.

Rat chronic feeding study; based on a NOEL of 100 ppm (3.4/4.1 mg/kg bw/day for males/females) based on reduced bodyweight gain and food efficiency at the next highest dose of 500 ppm

Pyridate

0.2

18

20 Jun 1991

 

 

Pyrifenox

0.007

0.07 (H)

30 Aug 1991

 

 

Pyrimethanil

0.2

17

1 Nov 1995

104-week dietary rat study; a NOEL of 400 ppm (17 mg/kg bw/d) was based on reduced body weight gains and food consumption at the next highest dose of 5000 ppm.

Supported by a 13-week dietary mice study; a NOEL of 80 ppm (18 mg/kg bw/d) was based on liver glycogen depletion at the next highest dose of 900 ppm.

Pyriproxyfen

0.07

7

11 Mar 1994

 

 

Pyrithiobac sodium

0.2

21

18 May 1995

18-month mouse dietary study; a NOEL of 150 ppm (21 mg/kg/day) was based on elevated peroxisomal beta-oxidation rates in females at the next highest dose of 1500 ppm.

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Pyrithione Copper

 

Pyroxsulam

 

not necessary

 

1

 

 

100

21 Jul 2004

 

14 April 2008

 

 

18-month mouse carcinogenicity study, based on increased absolute and relative liver weight in males associated with histopathological changes (increased incidence of clear cell foci of alteration) noted at 1000 mg/kg bw/d in a mice.

ADI not necessary; pyrithione is to be used as an antifouling paint on marine surface vessels.
The NOEL for the mouse study was 100 mg/kg bw/d.

q

 

 

 

 

 

Quinclorac

0.3

35

13 Sep 2004

1-year dietary study in dogs; the NOEL of 1000 ppm (35 mg/kg bw/d) was based on depressed food conversion efficiency in males, statistically significant decreases in plasma creatinine levels, and increased kidney weight in both sexes at the next highest dose of 4000 ppm (140 mg/kg bw/d).

Supported by a NOEL of 41 mg/kg bw for decreased bodyweights in a 78-week mouse dietary study.

Quindoxin

0.0007

1.5

7 Dec 1972

 

 

Quinoxyfen

0.2

20

15 Jan 2002

24-month rat dietary study and 12- month dog dietary study; based on increased organ weights, increased incidence of severe chronic progressive glomerulonephropathy and enhanced growth of testicular tumours in rats at the next highest dose of 80 mg/kg bw/day, and reduced body weight gain, increased liver weight, liver pathological changes and anaemia in dogs at the next highest dose of 200 mg/kg bw/day.

 

Quintozene

0.007

0.7

10 Sep 1987

 

 

Quizalofop-ethyl

0.01

1.25

12 Nov 1987

 

 

Quizalofop-P-tefuryl

0.01

1.3

14 Nov 1996

2-year rat dietary study; a NOEL of 25 ppm (1.3 mg/kg/day) was based on the induction of peroxisome proliferation with accompanying histopathological changes in the liver and tumourigenesis in the liver and testis at the next highest dose of 750 ppm.

 

r

 

 

 

 

 

Ractopamine

0.001

0.125

30 Jul 2002

1-year monkey gavage study and single-dose human study; based on increased heart rates and lower relative heart weight at the next highest dose of 0.5 mg/kg bw/day in monkeys and increased heart-rates in humans.

 

Resmethrin

0.1

10

11 Sep 1987

 

 

Rimsulfuron

0.02

1.6

24 Jun 1997

1-year oral dog study; a NOEL of (1.6 mg/kg/day) was based on biochemical changes, decreased body weight gains and testicular degeneration at the next highest dose of 81.8 mg/kg bw/d.

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Robenidine

0.005

10

17 Sep 1997

2-year dietary dog study; a NOEL of 400 ppm (10 mg/kg/day) was based on increased liver weights at 800

 

s

 

 

 

 

 

Saccharomyces cerevisiae

not necessary

 

4 Sep 2002

 

ADI not necessary. Used in the manufacture of food for human consumption.

Salinomycin

0.01

1

12 Nov 1981

 

 Top of page

Secbumeton

0.02

40

7 Dec 1971

 

 

Semduramicin

0.003

0.3

11 Jun 1997

1-year dog study; based on increased blood urea nitrogen, ALT and SDH levels and WBC counts, hypertension and ocular changes at the next highest dose of 1 mg/kg/d.

 

Sethoxydim

0.18

18

5 Aug 1982

 

 

Siduron

0.025

2.5

2 Mar 1994

 

 

Simazine

0.005

0.5

5 Dec 1990

 

 

Sodium cyanurate

0.5

50

14 Jan 1998

Developmental study in rabbits; based on reduced body weights at the next highest dose of 200 mg/kg bw/day.

 

Somidobove

not necessary

 

 

29 Aug 1991

ADI not necessary.

Spectinomycin
Spinetoram

1
0.06

100
6.0

5 Aug 1983
5 May 2008

 

The occurrence of decreased food consumption and body weight gain, vacuolation of macrophages, multifocal bone marrow necrosis and non-regenerative anaemia at doses above the NOEL of 6.0 mg/kg bw/day in a 28 day repeat dose study in the Beagle dog, suggested a need to protect the public from this expression of toxicity.  Accordingly a NOEL of 6.0 mg/kg bw/day was chosen as the basis for establishing the ADI using a standard safety factor of 100 The ADI was established as 0.06 mg/kg bw/day.

 

The SF of 100 consisted of a factor of 10 to account for variability in the extrapolation of the result from dog to human and a factor of 10 to account for variation in genetic susceptibility among humans.

Spinosad

0.02

2.4

2 May 1997

2-year rat dietary study; a NOEL of 0.005% (2.4 mg/kg/day) was based on histopathological effects at the next highest dose of 0.02%.

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Spiramycin
Spirotetramat

0.75
0.05

75
5

9 Feb 1978
18 Aug 2008

 

An acute oral neurotoxicity study, based on urine and perianal stain and decreased motor activity in rats at the next highest dose of ≥200 mg/kg bw/d

 

Spiroxamine

0.02

2.5

2 Jul 2001

12-month dietary dog study; a NOEL of 75 ppm (2.5 mg/kg bw/day) was based on liver and eye changes in both sexes and mild anaemia in females at the next highest dose of 1000 ppm.

 

Streptomycin (and dihydrostreptomycin)

0.05

5 (JECFA '97)

28 Jun 2001

2-year rat study; based on decreased body weight gains at the next highest dose of 10 mg/kg bw/d dihydrostreptomycin.

NOEL based on a study performed with dihydrostreptomycin due to the close relatedness of the two drugs.

Sulfadiazine

0.02

37.5

20 May 1993

 

 

Sulfadimidine

0.02

2

20 May 1993

 

 

Sulfadoxine

0.05

50

22 May 1995

3-month gavage monkey study; based on increased liver weights at the next highest dose of 166

 

Sulfamonomethoxine

0.006

12

20 May 1993

 

 

Sulfaquinoxaline

0.01

1

24 Jul 1997

90-day oral dog study; based on increased thyroid weights at the next highest dose of 1.5 mg/kg bw/day.

 

Sulfatroxazole

0.05

100

15 Mar 1994

 

 

Sulfentrazone

0.05

12

24 Jul 2006

2-generation rat reproduction study, based on decreased pup body weights and viability the next highest dose of 31 mg/kg/d

The NOELs for the rat and dog studies were 36 and 30 mg/kg/d, respectively.

Sulfometuron-methyl

0.02

2.5

29 Aug 1991

 

 

Sulfosulfuron

0.2

24

19 Dec 1997

2-year rat dietary study; a NOEL of 500 ppm was based on induced pathology in the kidneys and urinary bladder and associated biochemical and urinary findings at the next highest dose of 2000 ppm.

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Sulfur dioxide and equivalents (metabisulfites, sulfites, hydrogensulfites, thiosulfites)

0.7

JECFA'98

28 Feb 1998

 

 

Sulfuryl Fluoride

0.01

20 ppm

25 Aug 2006

2-year rat inhalation study (6 h/day, 5 days/week), based on effects on the kidney, brain, bone and survival at 80 ppm (5.6 mg/kg bw/d systemic exposure).

 

Sulprofos

0.003

0.3

21 Mar 1979

 

 

t

 

 

 

 

 

2,4,5-T

deleted

 

21 Oct 2003

 

 

Tebuconazole

0.01

1.5

16 Aug 1990

 

 

Tebufenozide

0.02

1.8

9 Oct 1996

2-generation dietary rat study; a NOEL of 25 ppm (1.8 mg/kg bw/day) for parental toxicity was based on the histopathology of the spleen at the next highest dose of 200 ppm.

 

Tebufenpyrad

0.002

0.2

15 Jan 1993

 

 

Tebuthiuron

0.07

7

14 Feb 1985

 

 

Tefluthrin

0.005

0.5

30 Apr 1993

 

 

Temephos

0.1

1

10 Feb 1988

 

 

Tepraloxydim

0.05

5

19 May 2002

2-year rat dietary study; a NOEL of 100 ppm (5 mg/kg/day) was based on serum changes and decreased kidney and liver weights at the next highest dose of 600 ppm. at the next highest dose of 600 ppm.

Supported by a 2-year rat carcinogenicity study; a NOEL of 100 ppm (5 mg/kg/day) was based on increased ovary weights and increased incidence of ovarian cysts at the next highest dose of 600 ppm.

Terbacil

0.06

6.25

12 Nov 1987

 

 Top of page

Terbufos

0.0002

0.0025

26 Nov 1992

 

 

Terbuthylazine

0.003

0.35

4 May 2001

24-month dietary rat study; a NOEL of 6 ppm (0.35 mg/kg bw/day) was based on decreased body weight gain and food consumption at the next highest dose of 30 ppm.

 

Terbutryn

0.1

10

29 May 1986

 

 

Tetrachlorvinphos

0.05

5

7 Dec 1971

 

 

Tetraconazole

0.004

0.4

12 Dec 2002

2-year rat dietary study; a NOEL of 10 ppm (0.4 mg/kg bw/day) was based on histopathological changes in the liver at the next highest dose of 80 ppm.

Supported by a 2-year rat reproduction study; a NOEL of 10 ppm (0.4 mg/kg bw/day) was established for both reproduction and postnatal toxicity, based on prolonged gestation, difficult parturition and consequent deaths, higher liver weights delayed vaginal opening and balanopreputial cleavage at the next highest dose of 80 ppm.

Tetradifon

0.02

2

5 Dec 1990

 

 

Tetramethrin

0.02

2

14 Aug 1992

 

 

Tetronasin

0.001

0.1

14 Feb 1992

 

 

Thiabendazole

0.3

3 (H)

2 Jun 1988

 

 

Thiacloprid

0.01

1.2

20 Jul 2001

2-year rat dietary study; a NOEL of 25 ppm (1.2 mg/kg bw/day) was based on enzyme induction in the liver and histopathological changes in the liver, thyroid and eyes at the next highest dose of 50 ppm.

 

Thiamethoxam

0.02

2

14 Apr 2000

2-generation reproduction rat study; a NOEL of 30 ppm (2 mg/kg bw/day) was based on lower body weight gains in the foetuses at the next highest dose of 1000 ppm.

 

Thidiazuron

0.02

2.5

20 Jun 1991

 

 Top of page

Thifensulfuron

0.01

1.25

16 Feb 1989

 

 

Thiobencarb

0.007

0.75

10 Nov 1977

 

 

Thiodicarb

0.03

3

5 Aug 1983

 

 

Thiometon

0.001

0.12

11 May 1989

 

 

Thiophanate

0.02

2

5 Dec 1985

 

 

Thiophanate-methyl

0.02

2

30 Aug 1991

 

 

Thiram

0.004

0.4

30 Mar 1995

2-year dietary dog study; based on neurological disturbances, anaemia and changes in the liver at the next highest dose of 4 mg/kg bw/day.

 

Tilmicosin

0.002

4

13 Aug 1992

 

 

Tiocarbazil

0.08

7.5

14 Dec 1978

 

 

Tolclofos-methyl

0.05

5

10 Feb 1988

 

 

Tolfenamic acid

0.005

0.5 (H)

16 Jan 2001

Single dose human therapeutic study; based on the lowest effective therapeutic (antipyretic) dose in humans.

 

Toltrazuril

0.01

1

4 Jan 1993

 

 Top of page

Tolylfluanid

0.1

12.5

11 Dec 1998

 

 

Tralkoxydim

0.005

0.5

29 Aug 1991

 

 

Transfluthrin

0.003

0.25

16 Oct 1995

53-week dietary dog study; based on the absence of treatment-related changes at 0.25 mg/kg bw/day.

 

Triadimefon

0.03

2.5

18 Feb 1987

 

 

Triadimenol

0.06

6.25

2 Jun 1988

 

 

Triallate

0.005

0.5

1 Dec 1988

 

 

Triasulfuron

0.005

0.5

14 Feb 1991

 

 

Triazbutil

0.06

6

10 Feb 1988

 

 

Tribenuron-methyl

0.01

0.95

15 Apr 1994

 

 

Trichlorfon

0.002

0.2

29 May 1986

 

 

Trichloropyridinol

0.03

3

23 Feb 1995

 

 

Triclabendazole

0.002

0.15

23 May 1996

2-generation rat gavage study; a NOEL of 3ppm (0.15 mg/kg bw/day) was based on increased pup mortality at the next highest dose of 15 ppm.

 

Triclopyr

0.005

0.5

5 Nov 1986

 

 

Tridemorph

0.02

2

10 Feb 1988

 

 Top of page

Trifloxystrobin

0.05

5

29 Sep 1998

52-week oral dog study; based on increased absolute and relative liver weights, hepatocellular hypertrophy, biochemical changes, diarrhoea, reduced food consumption and reduced weight gain at the next highest dose of 50 mg/kg bw/day.

 

Trifloxysulfuron

0.2

15

19 May 2002

12-month dog dietary study; a NOEL of 500 ppm (15 mg/kg bw/day) was based on increased liver weight, decreased bilirubin and atrophy in the thymus at the next highest dose of 1500 ppm.

 

Triflumizole

0.04

4

10 Sep 1987

 

 

Triflumuron

0.007

0.7

2 Jun 1988

 

 

Trifluralin

0.02

2.5

30 Aug 1991

 

 

Triforine

0.02

2.7

10 Sep 1987

 

 

Trimethoprim

0.02

33

20 May 1993

 

 

Trinexapac-ethyl

0.01

1.4

14 Dec 1993

 

 

Triticonazole

0.02

2

13 Jan 1997

13-week dietary rat study; a NOEL of 25 ppm (2 mg/kg bw/day) was based on altered histology of the adrenal cortex in males at the next highest dose of 250 ppm.

Supported by 52-week oral dog study; an NOEL of 2.5 mg/kg bw/day was based on adverse effects on the liver (clinical chemistry and enlargement) at the next highest dose of 25 mg/kg

Tylosin

0.3

30

15 Jan 1993

 

 

u

 

 

 

 

 

Ulocladium oudemansii

not necessary

 

12 Dec 2003

 

ADI not necessary; although there were insufficient data to establish an ADI, since no residues are anticipated, the establishment of an ADI is not necessary.

Uniconazole-P

0.02

1.86

3 Feb 2000

 

 

v

 

 

 

 

 

Vamidothion

0.005

0.05 (H)

8 May 1980

 

 Top of page

Vernolate

0.01

1

17 Aug 1989

 

 

Vinclozolin

0.01

1.4

16 Nov 1995

2-year dietary rat study; a NOEL of 25 ppm (1.4 mg/kg/day) was based on increased incidence of testicular masses, Leydig cell tumours, oligospermia and changes in the prostate and pituitary gland at the next highest dose of 50 ppm.

 

Virginiamycin

0.2

25

10 Feb 1988

 

 

z

 

 

 

 

 

Zeranol

0.0002

0.015

10 Feb 1988

 

 

Zeta-cypermethrin

0.07

7

23 May 1996

 

 

Zineb

0.005

5

27 Nov 1992

 

 

Ziram

0.01

1

21 Jun 1995

 

 

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