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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	834-12-8
Chemical Name	2-ethylamino-4-isopropylamino-6-methylthio-1,3,5-triazine; Ametryn
Substance ID	R02-B-096-MHLW, MOE
Classification year (FY)	FY2020
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 (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.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not 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	- -	-	-	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 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1) - (5). [Evidence Data] (1) LD50 for rats: 673 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)) (2) LD50 for rats: females: 1,009 mg/kg, males: 1,356 mg/kg (EPA Pesticides RED (2005), HSDB (Access on June 2020)) (3) LD50 for rats: females: 1,010 mg/kg, males: 1,360 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)) (4) LD50 for rats: 1,162 mg/kg (EPA Pesticides RED (2005)) (5) LD50 for rats: females: 1,420 mg/kg, males: 1,810 mg/kg (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) LD50 for rabbits: > 2,020 mg/kg (EPA Pesticides RED (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), HSDB (Access on June 2020)) (2) LD50 for rabbits: 8,160 mg/kg (Patty (6th, 2012), GESTIS (Access on June 2020), HSDB (Access on June 2020)) (3) LD50 for rats: > 3,100 mg/kg (Patty (6th, 2012), HSDB (Access on June 2020)) (4) LD50 for rats: > 5,000 mg/kg (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993))
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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (3.4E-005 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): > 5.03 mg/L (EPA Pesticides RED (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)) (2) LC50 for rats (4 hours): > 5.17 mg/L (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993)) (3) LC50 for rats (4 hours): > 6.50 mg/L (Patty (6th, 2012)) (4) Vapor pressure of this substance: 2.74E-006 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 3.4E-005 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (corresponding to Category 3 in UN GHS classification) from (1) - (4). [Evidence Data] (1) In a skin irritation test with rabbits according to EPA OPPTS 870.2500, it was judged as not an irritant (EPA Pesticides RED (2005)). (2) In eye and skin irritation tests with rabbits, this substance was judged as negative by the US EPA but as slightly irritating by APVMA, Australia (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) It is reported that this substance was slightly irritating to the skin of rabbits (Patty (6th, 2012)). (4) In a skin irritation test with rabbits according to OECD TG 404 on this substance, very slight erythema was noted one hour after patch removal but disappeared within 24 hours (REACH registration dossier (Access on September 2020)). [Reference Data, etc.] (5) In a skin irritation test with rabbits on a formulation of this substance (emulsion), slight irritation was observed, erythema disappeared after 14 days, and edema disappeared by day 4 (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993)). (6) In a skin irritation test with rabbits on a formulation of this substance (wettable powder), no irritation was found (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2 from (1) - (4). Besides, because the rationale for sub-categorization could not be obtained, sub-categorization was removed, and the classification result was changed. [Evidence Data] (1) In an eye irritation test with rabbits according to EPA OPPTS 870.2400, no corneal injury was seen, mild conjunctiva irritation (redness, chemosis, discharge) was observed, but the washed group recovered by 72 hours after application (EPA Pesticides RED (2005)). (2) In eye and skin irritation tests with rabbits, this substance was judged as negative by the US EPA but as slightly irritating by APVMA, Australia (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) It is reported that this substance produced mild or no irritation to the eyes of rabbits (Patty (6th, 2012)). (4) It caused moderate eye irritation (HSDB (Access on June 2020)). [Reference Data, etc.] (5) In an eye irritation test with rabbits on a formulation of this substance (emulsion), slight irritation (corneal opacity, iridial hyperemia, conjunctival redness and swelling) was observed, but corneal opacity was relieved but was still present in 1/6 animals at the end of observation (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993)). (6) In an eye irritation test with rabbits on a formulation of this substance (wettable powder), corneal and conjunctival irritation was found, and disappeared in most of the animals after two days but persisted in 1/6 animals by day 7 (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993)). (7) In an eye irritation test with rabbits according to OECD TG 405 on this substance (20 mg), it was judged as not an irritant (REACH registration dossier (Access on September 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) It was reported to be negative in a skin sensitization test with guinea pigs according to EPA OPPTS 870.2600 (EPA Pesticides RED (2005)). (2) In skin sensitization tests with guinea pigs, this substance was judged as negative by the US EPA but as a mild skin sensitizer by APVMA, Australia (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) It was reported to be negative in a skin sensitization test with guinea pigs according to EU Method B.6 (Skin Sensitization) (REACH registration dossier (Access on September 2020)). [Reference Data, etc.] (4) This substance was reported to be negative in a skin sensitization test with guinea pigs. However, in a skin sensitization test by intradermal administration (occlusive, 10 daily injections), no sensitization was seen following dermal application of challenge, but there was a positive response after intradermal challenge (Patty (6th, 2012)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test (Patty (6th, 2012)). It was reported to be negative in a micronucleus test with mouse bone marrow cells, and an unscheduled DNA synthesis test and a comet assay using rat liver (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), CEBS (Access on June 2020)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, a chromosomal aberration test and a mouse lymphoma test with cultured mammalian cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993), Patty (6th, 2012)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). An investigation was conducted by using new information sources, and the classification result was changed. [Evidence Data] (1) As for classification results by domestic and international organizations, EPA classified it in S (Suggestive Evidence of Carcinogenic Potential) (EPA Annual Cancer Report 2019 (Access on September 2020): classified in 2017). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, increases in testicular interstitial cell tumors, epididymal mesothelioma, and thyroid follicular cell tumors in males and hepatocellular adenoma and mammary gland adenocarcinoma in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) In a carcinogenicity test by 2-year diet administration of this substance to male and female mice, no treatment-related increase in neoplastic lesions was seen (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a two-generation reproduction study with rats dosed by feeding, at a dose at which parental animal toxicity effects (low body weight, reduced body weight gain, and a decrease in food consumption) were observed, low body weight and reduced body weight gain were observed in pups, but effects on fertility were not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, no effect in fetuses was observed at a dose at which maternal toxicity (hypoactivity, an increase in mortality, low body weight, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (3) In a developmental toxicity study with female rats dosed by gavage on days 6-15 of gestation, maternal toxicity (death, changes in behavior, decreases in food consumption and body weight, hemorrhagic degeneration of the implantation site) was observed, and in fetuses, low body weight, and delayed ossification were observed, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (4) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, no effect in fetuses was observed even at a dose at which maternal toxicity (decreases in body weight and food consumption, increases in absolute/relative liver weight) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] There was no report on acute exposure effects of this substance in humans. Based on (1) and (2), it was classified in Category 2 (nervous system). [Evidence Data] (1) As acute toxic symptoms in rats caused by this substance (the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at least around the LD50 values (oral: males: 1,810 mg/kg, females: 1,420 mg/kg, dermal: > 5,000 mg/kg, inhalation: > 5,170 mg/m3, within the range for Category 2)), a decrease in locomotor activity, salivation, lying on belly, lying on side, sedation, and gait abnormality were observed (Japanese Journal of Pesticide Science Vol. 18, No. 4 (Pesticide Science Society of Japan, 1993)). (2) In an acute oral toxicity test with mice, excessive salivation, lacrimation, tremor, ataxia, and recumbency were observed at or above 1,600 mg/kg (within the range for Category 2) (REACH registration dossier (Access on October 2020)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system, liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Based on (1) and (2), effects on the blood system and liver at doses of Category 2 were observed in experimental animals. Therefore, it was classified in Category 2 (blood system, liver). With the addition of new information, the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in a 90-day test with rats dosed by feeding, at or above 500 ppm (converted guidance value: 25 mg/kg/day, within the range for Category 2), prolonged prothrombin time was observed, and a decrease in hematocrit level and an increase in ALP were observed in females; and at 2,000 ppm (converted guidance value: 100 mg/kg/day, within the range for Category 2), a decrease in erythrocyte count and a decrease in hemoglobin were observed, and hemosiderin deposit to the spleen was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)). (2) It was reported that, in a 1-year test with dogs dosed by feeding, anemia, increases in AST, ALT, ALP, and gamma-GTP, granulomatous hepatitis, suppurative hepatitis, lymphocytic hepatitis, single cell necrosis, pigmentation, vacuolar degeneration, bile duct proliferation and necrosis, atrophy of the lymph tissue, testis, salivary gland, etc. were observed at or above 2,000 ppm (converted guidance value: 100 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 2.3 mg/L for crustacea (Mysidopsis bahia) (EPA RED, 2006). The classification result was changed from the previous classification by reviewing information.
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	It was classified in Category 2 because it was not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2001)) and due to 21-day NOEC = 0.24 mg/L for crustacea (Daphnia magna) (EPA RED, 2006). The classification result was revised from the previous classification by changing how to classify it for chronic toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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