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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	39680-90-5
Chemical Name	Ammonium methylcarbamodithioate; Metam-ammonium
Substance ID	R02-A-027-MHLW
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	New
Classification result in other fiscal year
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.
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	Classification not possible	- -	-	-	No data available. Besides, there is information that it degenerates even at normal temperatures (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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 (Not applicable)	- -	-	-	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."
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	- -	-	-	No data 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 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1), (2). [Evidence Data] (1) LD50 for rats: females: 402 mg/kg, males: 412 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)) (2) LD50 for rats: males: 706 mg/kg, females: 744 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] It was classified as "Classification not possible" because the category could not be determined from (1). [Evidence Data] (1) LD50 for rats: > 628 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
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 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] It was classified in Category 4 from (1). [Evidence Data] (1) LC50 for rats (aerosol (unknown if it is mist or dust): 4 hours): males: 1.98 mg/L, females: 3.20 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1). [Evidence Data] (1) In a skin irritation test with rabbits, tissue destruction was observed, and it was judged as corrosive (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] It was classified in Category 2B from (1). [Evidence Data] (1) In an eye mucosa irritation test with rabbits, corneal opacity and erythema, edema, and discharge in the conjunctiva were observed but disappeared at 7 days after application (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). [Reference Data, etc.] (2) This substance was classified in Category 1 in skin corrosion/irritation (GHS classification result in FY2020).
4	Respiratory sensitization	Classification not possible	- -	-	-	[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] It was classified in Category 1A from (1). [Evidence Data] (1) In a skin sensitization test with guinea pigs (maximization test, intradermal administration 1% and 5%), the positive rate was 100% after a challenge with 1% and 80% after a challenge with 5% (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells of mice dosed by single intraperitoneal administration, and an unscheduled DNA synthesis test using the hepatocytes of rats dosed by single oral dose, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (2) As for in vitro, negative results in a bacterial reverse mutation test and positive (S9+)/negative (S9-) results in a mammalian cell chromosome aberration test were obtained (Same as above). (3) There was a statement that it was considered that there was no genotoxicity that might become a problem for a living body (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There are no classification results by domestic and international organizations. There was no report available on humans. Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study with male and female rats dosed by gavage, there was no neoplastic lesion that increased in frequency by administration (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In an 18-month combined chronic toxicity/carcinogenicity study with male and female mice dosed by gavage, there was no neoplastic lesion that increased in frequency by administration, and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). [Reference Data, etc.] (3) In a two-year combined chronic toxicity/carcinogenicity study and an 18-month carcinogenicity study by oral administration of sodium salt (CAS RN 137-42-8) of this substance to rats dosed by feeding, no carcinogenicity was observed in either studies (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (4) In a two-year carcinogenicity study by oral administration of sodium salt (CAS RN 137-42-8) of this substance to male and female mice dosed by drinking water, an increase in the incidence of angiosarcoma of the spleen was observed in males and females, and therefore, the EU EFSA considered that there was limited evidence of carcinogenic effect (R40) in free acid (CAS RN 144-54-7) of this substance (EU EFSA (2011)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), a reduction in the number of live pups, an increase in the number of stillborn pups, etc. were observed at doses at which toxicity in parent animals was observed, and therefore, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a two-generation reproductive study with rats dosed by feeding, at a dose (15 mg/kg/day) at which an increase in liver weight in males and reduced body weight gain in females were observed in parent animals, a reduction in the number of live pups (without significant difference), an increase in the number of stillborn pups (without significant difference), and a reduction in the survival rate of newborns (on postnatal day 0) (significant only in F1 offspring) were observed in male and female offspring (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at doses where no maternal toxicity was observed, low body weight, a delay in ossification (cervical vertebral body), and skeletal variations (7th lumbar vertebra) were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, a tendency of reduced body weight gain and a reduction in food consumption (days 7 to 19 of gestation) were observed in dams, but no treatment-related effects were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). [Reference Data, etc.] (4) In a two-generation reproductive study by oral administration of sodium N-methyldithiocarbamate (CAS RN 137-42-8) to rats dosed by gavage, reduced body weight gain was observed in parent animals and offspring, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (5) In a developmental toxicity study by oral administration of sodium N-methyldithiocarbamate to female rats dosed by gavage on days 6 to 15 of gestation, at doses at which toxicity (reduced body weight gain, etc.) was observed in dams, meningocele, etc. were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (6) In another developmental toxicity study by oral administration of sodium N-methyldithiocarbamate to female rats dosed by gavage on days 6 to 15 of gestation, at doses at which toxicity (salivation, incontinence of urine, reduced body weight gain, etc.) was observed in dams, maxillary hypoplasia, cleft lip, internal hydrocephalus, skeletal abnormalities (increases in unossified cervical vertebral arch, unossified cervical vertebral body, and unossified sternebrae), skeletal variations, etc. were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (7) In a developmental toxicity study by oral administration of sodium N-methyldithiocarbamate to female rabbits dosed by gavage on days 6 to 18 of gestation, at a dose at which toxicity (reduced body weight gain, etc.) was observed in dams, an increase in resorption (without significant difference), an increase in post-implantation embryo loss, a reduction in the number of live fetuses (without significant difference), meningocele, and spina-bifida were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (8) In a developmental toxicity study by oral administration of sodium N-methyldithiocarbamate to female rabbits dosed by gavage on days 7 to 19 of gestation, at doses at which toxicity (a reduction in the amount of feces, reduced body weight gain, etc.) was observed in dams, complete embryo resorption (9 animals), an increase in early intrauterine deaths, an increase in post-implantation loss, a decrease in the number of live fetuses (without significant difference), meningocele, skeletal abnormalities (7th sternebra), etc. were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (3), it was classified in Category 1 (nervous system, respiratory organs). [Evidence Data] (1) In an acute oral toxicity test with rats, at or above 356 mg/kg (within the range for Category 2), a reduction in locomotor activity, crouching, salivation and lacrimation, lying on belly, and soiled fur in the lower neck, chest, and around the anus were observed, and from the day after the treatment, reduced body weight gain was observed in all treated groups. In dead animals, pleural effusion, retention of ascitic fluid, and stomach mucosal hyperemia and hemorrhage were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In an acute oral toxicity test with mice, at or above 228 mg/kg (within the range for Category 1), a reduction in locomotor activity, salivation, tonic convulsions, crouching, lying on belly, and soiled fur in the lower neck and around the chest were observed, and from the day after the treatment, reduced body weight gain was observed in all treated groups. In necropsy findings, pleural effusion, retention of ascitic fluid, gas-filled stomachs, and retention of serous fluid in the stomach were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a 4-hour inhalation exposure test with rats, at or above 0.694 mg/L (within the range for Category 1), a reduction in locomotor activity, salivation, crouching, eyelid ptosis, a decrease in respiration, smudge around the snout and mouth, stained fur, and lying on belly were observed. In dead animals, dark red lung, intratracheal foams, gastrointestinal gas, black spots in the glandular stomach mucosa, dark red spots in the thymus, white spots in the liver, and fading of the kidney and spleen were observed; and in live animals in males, contractile dysfunction of the lung at or above 1.63 mg/L (within the range for Category 2), and atrophy of the thymus in one animal at 2.76 mg/L (within the range for Category 2) were observed, and black spots in the glandular stomach mucosa in one female at 2.76 mg/L (within the range for Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There was no report on hazard by repeated exposure of humans to this substance. In test animals, effects on the liver were observed at doses of Category 1 or above in (1) and (2), and therefore, it was classified in Category 1 (liver). Effects on the stomach were also observed, but they were considered to be findings due to irritation, and therefore, they were not adopted as target organ toxicity. Effects on the blood system were observed only in males in (2), and were determined to be difficult to generalize, and therefore, they were not adopted as target organ toxicity. [Evidence Data] (1) It was reported that in a 90-day test with rats dosed by gavage, at or above 10 mg/kg/day (within the range for Category 1), hyperkeratosis and mucosal epithelium thickening in the forestomach were observed, and in males, an increase in the total excretion of sodium was also observed; and at 50 mg/kg/day (within the range for Category 2), salivation, an increase in total cholesterol, an increase in relative liver weight, and centrilobular hepatocyte hypertrophy were observed; and in males, increases in urinary volume and total excretion of chlorine, an increase in platelet count, increases in phospholipid, albumin, and A/G ratio, an increase in absolute liver weight, and hyperplasia of the mucosal epithelium of the glandular stomach were also observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) It was reported that in a one-year oral toxicity test with dogs dosed by capsules, at or above 3 mg/kg/day (within the range for Category 1), emesis and salivation, and an increase in AST were observed; and in males, increases in ALT and ALP, and mononuclear cell infiltration of the liver were also observed; and at 15 mg/kg/day (within the range for Category 2), animals died or were sacrificed in extremis (all males and 3/4 females by week 21 after the administration), and in these animals, single cell necrosis of the liver, mononuclear cell infiltration of the liver, stomach mucosa epithelium proliferation, vacuolar degeneration of the hepatocytes (males only), and an increase in leukocyte count (males only) were observed; and findings observed in females other than those before death or sacrifice in extremis were a reduction in red blood cell count, reductions in hematocrit and hemoglobin, prolonged activated partial thromboplastin time (APTT), increases in ALT, ALP, LDH and total bilirubin, and mononuclear cell infiltration of the liver. It was reported that at 100 mg/kg/day (within the range for Category 2), all animals died or were sacrificed in extremis by week 3 after the administration, and in these animals, vacuolar degeneration of the hepatocytes, stomach mucosa epithelium proliferation, and an increase in platelet count (males only) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
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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