NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	133-06-2
Chemical Name	Captan
Substance ID	R01-B-038
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	No data available. Besides, there is information that it may be flammable at special conditions (ICSC (2009)).
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(6), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 8,400-15,000 mg/kg (ACGIH (7th, 2014), IARC 30 (1983)) (2) LD50 for rats: 9,000 mg/kg (ACGIH (7th, 2014), EPA Pesticide (2004), Risk Assessment Report (Pesticides) (Food Safety J36Commission of Japan, 2018)) (3) LD50 for rats: >5,000 mg/kg (JMPR (2004)) (4) LD50 for rats: 12,600 mg/kg, >7,000 mg/kg (IPCS, PIM 98 (1992)) (5) LD50 for rats: male: 7,000 mg/kg, female: 6,170 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)) (6) LD50 for rats: male: 3,570 mg/kg, female: 4,320 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: >2,000 mg/kg (EPA Pesticide (2004)) (2) LD50 for rats: >5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)) (3) LD50 for rabbits: >4,500 mg/kg, >9,000 mg/kg (HSDB (Access on July 2019)) (4) LD50 for rabbits: >5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. [Evidence Data] (1) LC50 (4 hours, dust) for rats: (male) 0.72 mg/L, (female) 0.87 mg/L (EPA Pesticide (2004), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)) [Reference Data, etc.] (2) LC50 (2 hours) for rats: >5.7 mg/L (converted 4-hour equivalent value : 2.85 mg/L) (ACGIH (7th, 2014), HSDB (Access on July 2019))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) Skin irritation tests in humans (Caucasian men and women) showed irritation in both sexes, and moderate to severe erythema and edema were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) Symptoms of overexposure to this substance are irritation of the eyes and skin irritation and sensitization (HSDB (Access on July 2019)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) In an eye irritation test with this substance applied to the eyes of rabbits, the scores at 24/48/72 hours were 28-105 (maximum 110), and the animals did not recover even after 21 days (ECETOC TR48 (1998)). (2) This substance is a severe irritant to the eyes of humans (EPA Pesticide (2004)). [Reference Data, etc.] (3) It was classified as "Eye Dam. 1 (H318)" in the EU CLP classification (EU CLP classification (Access on July 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1A. [Evidence Data] (1) There are reports of a high rate (5%) of positive results in human patch tests with this substance (ACGIH (7th, 2014)). (2) Overexposure of this substance to humans indicates eye irritation, skin irritation and sensitization (HSDB (Access on July 2019)). (3) There are reports of dermatitis, urticaria, and persistent erythema that were related to exposure to this substance in humans (ACGIH (7th, 2014)). (4) A skin sensitization test (maximization method, intradermal induction: 0.1%, induction (topical application): 75%, challenge: 30%) with guinea pigs showed a positive result (positive rate of 40%) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)). (5) It was reported that in a skin sensitization test with guinea pigs according to OECD TG 406 (maximization method, intradermal induction: 0.1%, induction (topical application): 50%), this substance produced a 100% sensitization rate (REACH registration dossier (Access on July 2019)). [Reference Data, etc.] (6) This substance is a moderate skin sensitizer to guinea pigs (EPA Pesticide (2004)). (7) It was classified in Skin Sens.1 (H317) in the EU CLP classification (EU CLP classification (Access on July 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), many positive findings were observed in in vitro tests, and positive results were also reported in some of the in vivo tests. However, taking into account the negative results of many of the in vivo tests and the weight of evidence, based on expert judgment, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, gene mutation tests with transgenic mice showed negative results in the liver and duodenum (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). Negative results (partial positive) were reported in a dominant lethal test with mice, a micronucleus test with the bone marrow cells of mice and a somatic cell chromosomal aberration tests with mice and rats. Negative results were reported in a spot test with mice, an unscheduled DNA synthesis test with rat liver (ACGIH (7th, 2014), IARC 30 (1983), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). Although a positive result was obtained in a chromosomal aberration test with mouse spermatogonial cells and spermatocytes, increased chromosomal aberrations in spermatogonial cells were observed only in the high dose group (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)). (2) As for in vitro, although positive results were reported in bacterial reverse mutation tests, a chromosome aberration test and an HPRT test with cultured mammalian cells, and a mouse lymphoma test, decreased or eliminated mutagenicity was observed in some metabolic activation systems (ACGIH (7th, 2014), IARC 30 (1983), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) Several assessments concluded that there is sufficient evidence to establish the mutagenicity in cellular systems, but evidence in mammals was insufficient (IARC 30 (1983), IPCS, PIM 98 (1992), ACGIH (7th, 2014)). The Food Safety Commission concluded that this substance is genotoxic in vitro but not genotoxic in vivo, including target organs for carcinogenicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). As for in vivo, positive results were reported in micronucleus tests and a chromosomal aberration test with mice, all of which are from the same literature, but negative results were reported in other reports, and the positive results were not reproducible (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). [Reference Data, etc.] (4) It was reported that the mutagenicity of this substance can be rapidly eliminated by metabolism in vivo (ACGIH (7th, 2014)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] IARC classified it in Group 3, but in the latest assessment, it was classified in A3 by ACGIH and in Carc. 2 in the EU CLP classification. Therefore, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC Sup7 (1987)), in A3 by ACGIH (ACGIH (7th, 2014)), in Carc. 2 in EU CLP classification (EU CLP classification (Access on July 2019)). (2) No increase in the incidence of neoplastic lesions was observed in a combined chronic toxicity/carcinogenicity study in which this substance was administered to rats in the diet for 2 years and in a carcinogenicity test in which this substance was administered in the diet for 130 weeks (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) In two carcinogenicity tests in which this substance was administered in the diet to mice for 26 months and 22 months, increases in duodenal adenomas and adenocarcinomas were observed in males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), since fetal external, visceral and skeletal abnormalities, etc. were observed at doses at which maternal toxicity was observed, it was classified in Category 2. Besides, the classification result was changed because new information sources were cited. [Evidence Data] (1) In a developmental toxicity test in which female rabbits were administered by gavage on gestational days 7 to 19, the ratio of postimplanation loss and an increased number of dead embryos, a miscarriage (1 animal), malformations (encephalocele, severe abnormalities of the entire trunk, exencephaly/patent eyelid, etc., umbilical hernia, etc.), visceral abnormalities (extreme dilation of the aqueduct of the midbrain, a cyst on the surface of the liver), skeletal abnormalities (cebocephaly, fused maxillary bone, vertebral arch 11 defect, 11th rib defect, thumb defect), etc. were reported at doses where decreased fecal volume, diarrhea, decreased body weight, etc. were seen in maternal animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) In a developmental toxicity test with female hamsters administered by gavage on days 5 to 10 of gestation, increased resorptions, a decreased number of live fetuses, decreased fetal weight, a difference in sex ratio (male: female = 127:83), deformed tail, anasarca, combined abnormalities, etc. were reported at doses where increased mortality, etc. were observed in maternal animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). [Reference Data, etc.] (3) In a 3-generation reproductive toxicity test with rats dosed by feeding, in both parent animals and offspring, decreased body weight gain was observed and lowered fetal weight, etc. were observed, but no reproductive effects and teratogenicity were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There are no reports of single exposure to this substance in humans. Based on the information in (1) in experimental animals, it was classified in Category 1 (respiratory organs). The category was changed from the previous classification by the use of new information. [Evidence Data] (1) In a test in which rats were exposed by inhalation to the dust of this substance at 0.56, 0.71, and 1.36 mg/L for 4 hours, salivation, bloody tears, colored discharge from the nose and dyspnea were observed in surviving animals at or above 0.56 mg/L (equivalent to Category 1). As gross pathological findings, accumulation of white matter in the respiratory system (lung, pharynx and bronchus) was observed in a dose-dependent manner in the exposed groups. Deaths occurred from the lowest dose of 0.56 mg/L, and LC50 values were 0.72 mg/L in males and 0.87 mg/L in females. Although the number of deaths in each exposure group was not described, it is considered that a majority in the groups exposed below LC50 values of 0.56 and 0.71 mg/L survived (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)). In the pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016), it is described that these gross pathological findings suggest that the death of the animals was due to pulmonary dysfunction.
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), apparent toxicity was not observed within the guidance value range in oral administration to experimental animals and it was classified as "Not classified" for the oral route. Based on (3), it was also considered to correspond to "Not classified" for the dermal route. As for the inhalation route, there is no information, and the classification was not possible. [Evidence Data] (1) No adverse effects were observed at up to the guidance value range in 32 and 25-week feeding tests with rats and a 28-day feeding test with mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) The results of chronic toxicity tests, combined chronic toxicity/carcinogenicity studies and carcinogenicity tests with rats and mice showed no adverse effects at up to the guidance value range (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) In a 21-day dermal toxicity test with rabbits, no adverse effects were shown at up to the guidance value range, except for skin effects at or above 12.5 mg/kg/day (converted guidance value: 3 mg/kg/day, within the range of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.0262 mg/L for fish (Salmo trutta) (U.S. EPA: RED, 2004).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 because it was not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1989)), and due to 21-day NOEC = 0.56 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it was not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1989)), and due to 96-hour LC50 = 0.0262 mg/L for fish (Salmo trutta) (U.S. EPA: RED, 2004). From the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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