NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	7287-19-6
Chemical Name	2,4-Bis(isopropylamino)-6-(methylthio)-s-triazine; N,N'-Diisopropyl-6-(methylthio)-1,3,5-triazine-2,4-diamine; Prometryn
Substance ID	R02-A-030-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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)
Model SDS by MHLW (External link)
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (Accessed Sep. (2020)).
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.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
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.

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] The category with higher hazard was adopted from (1) - (9), and it was classified in Category 4. [Evidence Data] (1) LD50 for rats (males): about 1,450 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (2) LD50 for rats (females): about 1,440 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (3) LD50 for rats (males): about 1,802 mg/kg (EPA Pesticides RED (1996)) (4) LD50 for rats (females): about 2,076 mg/kg (EPA Pesticides RED (1996)) (5) LD50 for rats (females): > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (6) LD50 for rats: 3,750 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (7) LD50 for rats (males): 3,750 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (8) LD50 for rats (males): 3,350 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (9) LD50 for rats (females): 3,100 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) LD50 for rats (males): > 2,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (2) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (3) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (4) LD50 for rats: > 3,170 mg/kg (EPA Pesticides RED (1996))
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) - (3). [Evidence Data] (1) LC50 for rats (4 hours): about 4.96 mg/L (EPA Pesticides RED (1996)) (2) LC50 for rats (4 hours): > 2.17 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (3) LC50 for rats (4 hours): > 2.26 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) Slight skin irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) Slight irritation was seen in a skin irritation test with rabbits (EPA Pesticide RED (1996), HSDB (Accessed Sep. 2020)).
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) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) Mild irritation was observed in an eye irritation test with rabbits (EPA Pesticides RED (1996)). [Reference Data, etc.] (2) Slight irritation to the eye mucosa was found in an eye irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
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), (2) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) No skin sensitization was seen in a Buehler test with guinea pigs (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) No skin sensitization was found in a skin sensitization test with guinea pigs (EPA Pesticides RED (1996), HSDB (Accessed Sep. 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test with mouse bone marrow cells (oral administrations), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In a chromosomal aberration test with hamster bone marrow cells (oral administrations), negative results were obtained (EPA Pesticides RED (1996), Patty (6th, 2012)). (3) In a reverse mutation test, negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (1996)). (4) In a mammalian cell chromosome aberration test, negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (5) In a UDS test, negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (1996)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, EPA classified this substance in Group E (Evidence of Non-Carcinogenicity for Humans) (EPA Pesticides RED (1996), EPA Annual Cancer Report 2018 (Accessed Spt. 2020): Classification in 1994). (2) In two two-year chronic toxicity/carcinogenicity studies with rats dosed by feeding, at doses of up to 3,000 ppm (males/females: 119/140 mg/kg/day) in one and at doses of up to 1,500 ppm (males/females: 40.9/80.6 mg/kg/day) in the other, no treatment-related increase in the incidence of neoplastic lesions was observed. No carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (1996)). (3) In a two-year chronic toxicity/carcinogenicity study with mice dosed by feeding, no treatment-related increase in the incidence of neoplastic lesions was observed at doses up to 3,000 ppm (males/females: 475/530 mg/kg/day). No carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (1996)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." In (4), increased late resorption and a decrease in the mean number of live fetuses were observed in parental animals, which were not significant changes. [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, no effects on fertility were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (2015)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage, an increase in delayed ossification (phalanx and calcanei) was observed in pups at 100 mg/kg/day, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) It was reported that in a developmental toxicity study with rats dosed by gavage, at 250 mg/kg/day, a decrease in body weight, reduced body weight gain and decreased food consumption were observed in parental animals and lower body weight, and delayed ossification (sternums and metacarpal bones) were observed in pups, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (2015)). (4) It was reported that in a developmental toxicity study with rabbits dosed by gavage, at 72 mg/kg/day, abortion (two cases, on days 16 and 23 of gestation), reduced body weight gain, decreased food consumption, increased late resorption, and a decrease in the mean number of live fetuses (nonsignificant) were observed in parental animals and delayed ossification (forelimb proximal phalanx) was observed in pups, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (2015)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (7), it was classified as "Not classified." The symptoms of the nervous system observed in (2) and (4) were possibly nonspecific in the vicinity of lethal dose, and they were not observed in the acute neurotoxicity test of (1). Therefore, the nervous system was not adopted as a target organ. In (6) and (7), the symptoms such as abnormal respiratory movement were observed, and it was suspected that this substance might be irritant to the respiratory tract. But reduced response to sound was observed in (6). Therefore, the findings were considered to be secondary to the deterioration of physical condition and the respiratory tract was not adopted as a target organ. [Evidence Data] (1) It was reported that in an acute neurotoxicity test with rats, a decreased amount of walking motions (on the day of the administration) was observed at or above 500 mg/kg (within the range for Category 2), and reduced body weight gain and decreased food consumption were observed at 1,500 mg/kg (within the range for Category 2), but in a detailed functional test (FOB) and a neurohistopathological study, no treatment-related effects were observed. It was reported that no acute neurotoxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) It was reported that in an acute oral toxicity test with rats, sedation, ataxia, coma, salivation, incontinence of urine, and diarrhea were observed at 839 mg/kg (within the range for Category 2) and deaths were observed at 1,049 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) It was reported that in an acute oral toxicity test with rats, staining of the face, piloerection, and a decreased amount of feces were observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (4) It was reported that in an acute oral toxicity test with mice, sedation, ataxia, convulsive seizure, hypodynamia, coma, salivation, lacrimation, and piloerection were observed at 1,470 mg/kg (within the range for Category 2) and deaths were observed at 1,843 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (5) It was reported that in acute dermal toxicity tests with rats and mice, no effects were observed at 2,000 to 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (6) It was reported that in an acute (dust) inhalation toxicity test with rats, reduced respiratory frequency, increased depth of respiration, reduced responses to sound, decreased activity, salivation, and a reduction in hindlimb withdrawal reflex were observed at 2.17 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (7) It was reported that in an acute (dust) inhalation toxicity test with rats, abnormal respiratory movement, salivation, half-closed eyes, and brown staining of the muzzle and the hair coat around the jaw were observed at 2.26 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system, liver, kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (5), it was classified in Category 2 (blood system, liver, kidney). [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, hematological effects (decreases in Hb and Ht, increases in platelet count and red blood cells) (females) were observed at 1,000 ppm (64 mg/kg/day (males), 80.8 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding, hematological effects (a decrease in Ht, an increase in platelet count (males), decreases in red blood cell count, Hb, and PTT (females)), liver effects (increases in absolute and relative weight, localized necrosis of cells with fibrosis, and cellular hypertrophy (males), granulocyte infiltration, an increase in ALT/GGT (females)), an increase in heart rate (males) and increased ketone bodies in urine (females) were observed at 2,000 ppm (70.6 mg/kg/day (males), 82.8 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, increased urobilinogen in urine and increased urinary crystals (males) were observed at 1,000 ppm (38 mg/kg/day (males), 45.4 mg/kg/day (females), within the range for Category 2), kidney effects (such as increases in absolute and relative weight, colloid degeneration (equivalent to hyaline cast), increased urinary protein) and hematological effects (such as decreases in RBC, Hb, and Ht, an increase in PLT) were observed at 3,000 ppm (119 mg/kg/day (males), 140 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (4) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with another strain of rats dosed by feeding, kidney effects (renal pelvis calculi (males), increases in absolute and relative weight (females)) and hematological effects (decreases in Hb and Ht) (females) were observed at 1,500 ppm (40.9 mg/kg/day (males), 80.6 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), EPA Pesticides RED (1996)). (5) It was reported that in a two-year chronic toxicity study with dogs dosed by feeding, liver effects (degenerative hepatic changes, congestion) (males), kidney effects (such as renal tubule degeneration and cortical congestion) and slight bone marrow atrophy were observed at 1,500 ppm (37.5 mg/kg/day, within the range for Category 2) (EPA Pesticides RED (1996), IRIS (1987)).
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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