NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	868680-84-6
Chemical Name	3-Chloro-N-[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]-1-methyl-4-(5-methyl-5,6-dihydro-1,4,2-dioxazin-3-yl)-1H-pyrazole-5-sulfonamide; Metazosulfuron
Substance ID	R02-A-015-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	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	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (S=O) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to the heat of 150 deg C or below (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data.
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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: females: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
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). [Evidence Data] (1) LC50 for rats (nose exposure, 4 hours): > 5.05 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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 irritation test with rabbits, the mean score for conjunctival redness and chemosis at 24/48/72 hours after application was calculated as 2.0 and 0.67, and it was slightly irritating, but signs were reversible by 7 days after application (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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). [Evidence Data] (1) No sensitization was observed in a sensitization test with guinea pigs skin (maximization test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test with the bone marrow cells of orally dosed mice, and in a comet assay (liver and uterus) of orally dosed rats, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) As for in vitro, in a bacterial reverse mutation test, and an in vitro mammalian cell chromosome aberration test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[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 in Category 2. [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study with male and female rats dosed by feeding, a significant increase in the incidence of endometrial adenocarcinoma was observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (2) In a 18-month carcinogenicity study with male and female mice dosed by feeding, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] The data of (1) to (3) were available. Based on (2), effects in fetuses were observed at a dose where maternal toxicity was observed, but since the dose was 1,000 mg/kg/day, which was high, the substance was classified in Category 2. [Evidence Data] (1) In a two-generation reproduction study with rats dosed by feeding, at a dose at which parental toxicity effects (reduced body weight gain, an increase in liver weight) were observed, reduced body weight gain was observed in pups but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 19 of gestation, at 1,000 mg/kg/day, maternal toxicity effects (reduced body weight gain, decreases in food consumption, uterine weight, and placental weight) were observed, and fetal toxicity effects (a decrease in body weight, visceral variations, skeletal variations, an increase in the incidence of delayed ossification) were observed. In a few fetuses, abnormalities in the heart/aorta (abnormal heart rotation, right aortic arch, ventricular septal defect), an increased incidence of cervical ribs, thickening/tubercles of ribs and delayed ossification (skull, thoracic vertebra, sternebrae, etc.) were observed, and they were considered to be related to the administration of the test substance (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). The Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012) indicated that "since no toxicity findings were observed in fetuses of rabbits, it was considered not to be teratogenic." (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 28 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity effects (decreases in water intake and the amount of feces, decreases in body weight and food consumption, and abortion and premature delivery (in the late stage of gestation) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[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), there were no findings by which target organs could be identified in any of the tests in the oral, dermal, and/or inhalation routes. Therefore, it was classified as "Not classified." [Evidence Data] (1) In an acute oral toxicity test with female rats, at or above 2,000 mg/kg (the upper limit of Category 2), there was no death case, and salivation, an increase in respiration rate, and hunched posture were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (2) In an acute dermal application test with rats, at or above 2,000 mg/kg (the upper limit of Category 2), there was no death case, and slight erythema was observed at the applied area (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (3) In a four-hour inhalation exposure test with rats (nasal exposure), at or above 5.05 mg/L (exceeding Category 2), there was no death case, and an increase in respiration rate, hunched posture, piloerection, and wet fur were observed but they were common reactions in inhalation toxicity tests with restraint treatment (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] There was no report on hazard by repeated exposure to this substance in humans. In experimental animals, based on (1) to (3), at the doses for Category 2, the effects on the liver were observed. Therefore, it was classified in Category 2 (liver). In (1), the effect on the blood system observed in the range for Category 2 was extramedullary hematopoiesis, which was observed only in females and in one case in each group. Therefore, the blood system was not adopted as the target organ. [Evidence Data] (1) It was reported that in one of two 13-week oral toxicity studies with dogs dosed by capsules, at or above 100 mg/kg/day (within the range for Category 2), inflammatory foci of hepatocytes were observed; and at 500/300 mg/kg (500 mg/kg/day until day 10 of post-administration; 300 mg/kg from day 11 onwards, exceeding Category 2), sacrifice in emergency (4/4 males, 1/4 females), decreases in hematocrit value, hemoglobin, and red blood cell count, increases in reticulocyte count and mean corpuscular volume, increases in neutrophil count and white blood cell count, a decrease in platelet count, shorter activated partial thromboplastin time, and inflammatory foci of hepatocytes were observed. Furthermore, anisocytosis and macrocytosis were observed in females; and in the other test, at or above 85 mg/kg/day (within the range for Category 2), inflammatory foci of hepatocytes in males and hepatomegaly, extramedullary hematopoiesis of the liver and spleen in females (one case in each group) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (2) It was reported that in a feeding toxicity study with rats, longer activated partial thromboplastin time was observed in females at or above 1,500 ppm (males/females: 82.7/106 mg/kg/day, within the range for Category 2/exceeding Category 2) after one-year administration, and centrilobular hypertrophy of the hepatocytes was observed in females at or above 1,500 ppm (males/females: 68.9/94.2 mg/kg/day, both within the range for Category 2) after two-year administration (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (3) It was reported that in an 18-month oral toxicity study with mice dosed by feeding, at or above 800 ppm (males/females: 89.1/104 mg/kg/day, within the range for Category 2/exceeding Category 2), centrilobular hypertrophy of the hepatocytes and vacuolization of the hepatocytes were observed in males, and pigmentation of liver macrophages was observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). [Reference Data, etc.] (4) It was reported that in a 21-day dermal exposure test with rats, there were no toxicity findings at the dose range for Category 1 and Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour ErC50 = 0.0308 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.00502 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it is not rapidly degradable (BIOWIN) and due to 48-hour EC50 > 101 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). By drawing a comparison between the above results, it was classified in Category 1.
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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