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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	137-30-4
Chemical Name	bis[(dimethylcarbamothioyl)sulfanyl]zinc; Ziram
Substance ID	R02-B-042-MHLW
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2006 FY2019
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (ICSC (2005)).
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	Because it is classified in Division 6.1 in UNRTDG (UN2757), it does not correspond to pyrophoric substances, hazards of the highest precedence. Therefore, it was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metal (Zn), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 65 mg/L (25 deg C) (HSDB (Access on May 2020)).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1) - (7). Besides, the classification result was changed from the previous classification due to the use of new information sources. [Evidence Data] (1) LD50 for rats: 200-400 mg/kg (JMPR (1996)) (2) LD50 for rats: 267 mg/kg (Canada Pesticides (2016), Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011), GESTIS (Access on May 2020)) (3) LD50 for rats: 270 mg/kg (JMPR (1996), MAK (DFG) (2016), GESTIS (Access on May 2020)) (4) LD50 for rats: 320 mg/kg (Canada Pesticides (2016), EPA Pesticides RED (2003), MAK (DFG) (2016), HSDB (Access on May 2020)) (5) LD50 for rats: males: 380 mg/kg (MAK (DFG) (2016), GESTIS (Access on May 2020)) (6) LD50 for rats: males: 1,208 mg/kg, females: 873 mg/kg (Japanese Journal of Pesticide Science Vol. 17 No. 2 (Pesticide Science Society of Japan, 1992)) (7) LD50 for rats: 1,400 mg/kg (MAK (DFG) (2016))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (5). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (AICIS (formerly NICNAS) IMAP (2014)) (2) LD50 for rats: > 5,000 mg/kg (Japanese Journal of Pesticide Science Vol. 17 No. 2 (Pesticide Science Society of Japan, 1992)) (3) LD50 for rats: > 6,000 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020)) (4) LD50 for rabbits: > 2,000 mg/kg (MAK (DFG) (2016), GESTIS (Access on May 2020)) (5) LD50 for rabbits: > 5,010 mg/kg (GESTIS (Access on May 2020))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (7). Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (1.2E-007 mg/L), a reference value in the unit of mg/L was applied as dust. The saturated vapor pressure concentration was calculated by using data at 0 deg C. [Evidence Data] (1) LC50 for rats (4 hours): females: 0.06 mg/L (MAK (DFG) (2016)) (2) LC50 for rats (4 hours): 0.08 mg/L (MAK (DFG) (2016)) (3) LC50 for rats (nose exposure, 4 hours): 0.13 mg/L (MAK (DFG) (2016)) (4) LC50 for rats (4 hours): males: 0.18 mg/L (MAK (DFG) (2016)) (5) LC50 for rats (4 hours): 0.06-0.18 mg/L (GESTIS (Access on May 2020)) (6) LC50 for rats (4 hours): 0.081 mg/L (HSDB (Access on May 2020)) (7) LC50 for rats (4 hours): males: 0.12 mg/L, females: 0.16 mg/L (Japanese Journal of Pesticide Science Vol. 17 No. 2 (Pesticide Science Society of Japan, 1992)) (8) Vapor pressure of this substance: 7.5E-009 mmHg (0 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 1.2E-007 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). The classification result was changed because the previous classification was determined based on data in rats in which application time was unknown, and new data were obtained. [Evidence Data] (1) It was not irritating in a skin irritation test with rabbits (JMPR (1996), Canada Pesticides (2016), EPA Pesticides RED (2003), GESTIS (Access on May 2020)). (2) This substance was not irritating to the skin (MAK (DFG) (2016)). (3) In a skin irritation test with rabbits according to OECD TG 404, the mean scores at 24/48/72 hours were all 0 (REACH registration dossier (Access on July 2020)). [Reference Data, etc.] (4) It severely irritates the eye and irritates the skin and respiratory tract. It causes erythema and pains in an entry in the eye or contact with the skin (Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1) - (5). The classification result was changed due to new data obtained. [Evidence Data] (1) It caused severe irritation in an eye irritation test with rabbits (JMPR (1996), Canada Pesticides (2016), EPA Pesticides RED (2003), GESTIS (Access on May 2020)). (2) This substance was not irritating to the skin but was corrosive to the eyes (MAK (DFG) (2016)). (3) It is described that in an eye irritation test with a rabbit according to OECD TG 405, scores at 24 hours after application were 3 for corneal opacity, 2 for the iris, 3 for conjunctival redness, and 4 for chemosis, necrosis and destruction of the nictitating membrane were seen, and the animal was euthanized at 24 hours after application (REACH registration dossier (Access on July 2020)). (4) It severely irritates the eye and irritates the skin and respiratory tract. It causes erythema and pains in an entry in the eye or contact with the skin (Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). (5) In an eye irritation test with rabbits on this substance, irritation reactions were seen in the cornea, iris, and conjunctiva, and highly necrotic changes were observed in the cornea and conjunctiva (Japanese Journal of Pesticide Science Vol. 17 No. 2 (Pesticide Science Society of Japan, 1992)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (3). The classification result was changed because new data were obtained. [Evidence Data] (1) It was moderately sensitizing in a skin sensitization test with guinea pigs (JMPR (1996), Canada Pesticides (2016), EPA Pesticides RED (2003), GESTIS (Access on May 2020)). (2) It was reported to be positive in a skin sensitization test with guinea pigs according to OECD TG 406 and EPA OPP 81-6 (Split adjuvant test) (REACH registration dossier (Access on July 2020)). (3) Repeated or long-term contact could cause skin sensitization (Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). [Reference Data, etc.] (4) This substance was reported to be negative in a skin sensitization test with guinea pigs (maximization test, intradermal administration 5%) (Japanese Journal of Pesticide Science Vol. 17 No. 2 (Pesticide Science Society of Japan, 1992)). (5) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on July 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] From (1) - (4), it was classified as "Not classified" based on expert judgment. [Evidence Data] (1) As for in vivo, it was reported to be negative in a chromosomal aberration test and a sister chromatid exchange test using mouse bone marrow (EHC 78 (1988), IARC 53 (1991), CEBS (Access on May 2020), MAK (DFG) (2016)). (2) As for in vitro, it was reported to be positive and negative in bacterial reverse mutation tests and positive in a gene mutation test with mouse lymphoma cells and a chromosomal aberration test with cultured mammalian cells. It was reported to be negative in a gene mutation test with mouse lung cells and a sister chromatid exchange test with cultured mammalian cells (same as the above). It is described in MAK (DFG) that positive results in in vitro genotoxicity tests were attributed to cytotoxicity (MAK (DFG) (2016)). (3) An increase in chromosomal aberrations was reported in the peripheral blood of workers exposed to this substance (IARC 53 (1991)), but it is described in MAK (DFG) that it cannot be regarded as evidence of genotoxic effects (MAK (DFG) (2016)). (4) It is described in MAK (DFG) that this substance is considered to be not genotoxic (MAK (DFG) (2016)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There were no available reports in humans. In classification results by other organizations in (1), IARC classified it in Group 3, but based on results in experimental animals in (2) and the EPA's classification result, it was classified in Category 2. The classification result was changed by reviewing information. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC 53 (1991)) and S (Suggestive Evidence of Carcinogenicity, but not Sufficient to Assess Human Carcinogenic Potential) by EPA (EPA Cancer Annual Report 2019 (Access on July 2020): classification in 2003). (2) In carcinogenicity tests by 2-year diet administration of this substance (purity 89%, thiram 6.5%) to male and female rats and mice, a significant increase in the incidence of C-cell carcinoma of the thyroid in male rats and significant increases in the incidences of alveolar/bronchiolar adenoma and alveolar/bronchiolar adenoma or carcinoma (combined) in female mice were observed. No tumor incidences were found in female rats or male mice (NTP TR 238 (1983), IARC 53 (1991), EPA Pesticides RED (2003)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, a decrease in litter size, a decrease in fetal body weight, and a decrease in crown-rump length were observed at a dose at which maternal toxicity (reduced body weight gain) was observed (Environmental Risk Assessment for Chemical Substances Vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)), JMPR (1996), MAK (DFG) (2016)). [Reference Data, etc.] (2) In a two-generation reproduction toxicity test with rats dosed by feeding, decreases in food consumption and water intake and reduced body weight gain were observed in parental animals and similar changes were also observed in pups during the growing period, but no effects on fertility and no teratogenicity were observed (Japanese Journal of Pesticide Science Vol. 17, No. 2 (Pesticide Science Society of Japan, 1992)). (3) In a two-generation reproduction toxicity test with rats dosed by feeding, reduced body weight gain was observed in parental animals, and although reduced body weight gain was also observed in pups, no reproductive effects were observed (Environmental Risk Assessment for Chemical Substances Vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)), JMPR (1996), MAK (DFG) (2016)). (4) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose at which maternal toxicity (salivation, reduced body weight gain) was observed, lower body weight was observed in fetuses but no teratogenicity was observed (Environmental Risk Assessment for Chemical Substances Vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)), JMPR (1996), MAK (DFG) (2016)). (5) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, at a dose at which maternal toxicity (a decrease in food consumption, death (1/15 cases), and miscarriage (1 case)) was observed, delayed ossification and increases in skeletal variations were observed in fetuses but no teratogenicity was observed (Japanese Journal of Pesticide Science Vol. 17, No. 2 (Pesticide Science Society of Japan, 1992)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system), Category 3 (narcotic effects, respiratory tract irritation)	Warning	H371 H336 H335	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2 (nervous system) and Category 3 (narcotic effects, respiratory tract irritation). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In an acute inhalation exposure test of this substance (purity: 98.5%) with rats, gasping, a decrease in respiratory rate, lethargy, piloerection, ataxia, and ptosis were observed, and the necropsy of the dead rats showed reddening and swelling of the lungs. Judging from the 4-hour LC50 (0.13 mg/L), this substance was considered to produce effects at doses within the range for Category 2 (MAK (DFG) (2016)). (2) In an acute oral toxicity test with rats, cyanosis, hypothermia, enophthalmus, unsteady gait, hypoactivity, ptosis, abnormal respiration, softer fecal consistency, changes in FOB (altered posture, closed eyes, lacrimation, salivation, changes in respiratory rate), a decrease in locomotor activity, less sensitivity at the tail and to olfactory stimuli, no startle response, extension (reflex) of the front or hind legs (females), and death (females) were observed at or above 300 mg/kg (within the range for Category 2); and a decrease in muscle tonus, emaciation (females) and death (males and females) were observed at 600 mg/kg (within the range for Category 2) (MAK (DFG) (2016)). (3) This substance is severely irritating to the eyes and irritating to the skin and respiratory tract. When it gets in the eye or on the skin, it causes redness and pain. When it is inhaled, it causes cough, sore throat, stomachache, nausea, and vomiting. When it is orally ingested, it causes stomachache, nausea, and vomiting (Environmental Risk Assessment for Chemical Substances Vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). [Reference Data, etc.] (4) Oral intake of 0.5 L of a solution of this substance (no details described) caused death of a human within a few hours. In a histopathological examination, focal necrosis to the mucous membranes of the small intestine, hemorrhage and edema in various organs, and damages to the lung (focal atelectasis, acute emphysema, desquamation of the alveolar and bronchial epithelium) were observed and they were pathologically non-specific symptoms (GESTIS (Access on May 2020), HSDB (Access on May 2020)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, respiratory organs, blood system, liver, muscle, thyroid, adrenal gland)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] In the inhalation route, based on (1), effects on the nervous system and respiratory organs were observed in humans, and based on (2), effects on the respiratory organs were observed in experimental animals at doses within the range for Category 1. In the oral route, based on (3) to (5), effects on the blood, liver, muscle, thyroid and adrenal gland were observed at doses within the range for Category 1. In addition, hyperplasia and edema in the non-glandular epithelium of the stomach, which were considered to be caused by irritation, were observed. Therefore, it was classified in Category 1 (nervous system, respiratory organs, blood system, liver, muscle, thyroid, adrenal gland). As a result of examination with the addition of new information sources, the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in a long-term inhalation exposure of humans, disorders of the nervous system and visual system, dermatitis, and irritation signs in the upper respiratory tract occurred (Environmental Risk Assessment for Chemical Substances Vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). (2) In a 28-day inhalation toxicity test with rats (6 hours/day, 5 days/week), inflammation, squamous metaplasia, hyperplasia and necrosis in the larynx, and a decrease in MCHC were observed at or above 0.3 mg/m3 (converted guidance value: 0.000093 mg/L, within the range for Category 1); and fibrosis in the alveolar duct and prominent goblet cells in the bronchioles, bronchiolar metaplasia in the alveolar duct, and bronchiolitis were observed at or above 1 mg/m3 (converted guidance value: 0.00031 mg/L, within the range for Category 1) (MAK (DFG) (2016)). (3) In a one-year oral toxicity test with rats dosed by feeding, a decrease in red blood cell count was observed at or above 3 mg/kg/day (within the range for Category 1); reduced body weight gain, decreases in T3 and T4, an increase in blood urea, adipose tissue replacement, narrowing of myofibers of the skeletal muscles, hemosiderosis in the spleen, bile duct hyperplasia in the liver, pigmentation of sinusoidal liver cells, cysts in the ultimobranchial region of the thyroid, hyperplasia in the non-glandular epithelium of the stomach, adipose tissue replacement in the pancreas, adrenal hypertrophy with vacuolation, edema in the non-glandular epithelium of the stomach, decreases in hematocrit and hemoglobin, and adrenal cystic degeneration were observed at or above 9.1/12 mg/kg/day (within the range for Category 1); and brown pigmentation of the sinusoidal cells in the liver, thyroid C-cell hyperplasia, atrophy in the exocrine pancreas, and corpora lutea absence were observed at 27/38 mg/kg/day (within the range for Category 2) (MAK (DFG) (2016)). (4) In an 80-week oral toxicity test with mice dosed by feeding, enlarged centrilobular hepatocytes were observed at or above 3/4 mg/kg/day (within the range for Category 1); reduced body weight gain and epithelial hyperplasia in the bladder were observed at or above 27/33 mg/kg/day (within the range for Category 2); a decrease in the amount of adipose tissue, cortical scars in the kidneys, and brown kidneys were observed at 82 mg/kg/day (within the range for Category 2); and epithelial hyperplasia in the bladder was observed at 95 mg/kg/day (within the range for Category 2) (MAK (DFG) (2016)). (5) In a one-year oral toxicity test with dogs dosed by feeding, an increase in pigmented Kupffer’s cells in the liver, an increase in pigmented macrophages in the spleen, increases in ALT, ALP, and AST activities, and increases in centrilobular fibrocytes in the liver were observed at or above 6.6/6.7 mg/kg/day (within the range for Category 1); and liver foci with degenerated hepatocytes, inflammatory cells in liver veins, and liver cell necrosis were observed at 17.4/20.6 mg/kg/day (initially 24/30 mg/kg/day) (within the range for Category 2) (MAK (DFG) (2016)). [Reference Data, etc.] (6) In oral administration studies with rats, mice, and dogs, toxicity effects mainly on the liver, thyroid, adrenal gland, muscle, hematopoietic and nervous systems, and testes were found (MAK (DFG) (2016)).
10	Aspiration hazard	Classification not possible	- -	-	-	[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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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