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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	100784-20-1
Chemical Name	Methyl 3-chloro-5-(4,6-dimethoxy-2-pyrimidinylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate; Halosulfuron-methyl
Substance ID	R02-B-124-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
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, a sulfonyl group, 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 an autoignition temperature of > 400 deg C (RAC Background Document (2017)).
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 (S). However, the classification is not possible due to no data. Besides, there is information that the substance is not oxidizing (RAC Background Document (2017)).
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) - (3). [Evidence Data] (1) LD50 for rats: 7,758 mg/kg (EU EFSA (2012)) (2) LD50 for rats: females: 7,758 mg/kg, males: 10,435 mg/kg (EU CLP CLH (2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)) (3) LD50 for rats: females: 7,760 mg/kg, males: 10,400 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
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 (EU CLP CLH (2017), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU EFSA (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008))
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 (4 hours): > 6 mg/L (EU CLP CLH (2017), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU EFSA (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) In a skin irritation test with rabbits according to OECD TG 404 on this substance, no skin reactions were seen, and it was judged as not a skin irritant (RAC Background Document (2017)). (2) In a skin irritation test with rabbits, no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU EFSA (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) In an eye irritation test with rabbits according to OECD TG 405 on this substance, conjunctival redness of score 1 was observed but completely disappeared within 72 hours after application (RAC Background Document (2017)). (2) In an eye irritation test with rabbits, no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU EFSA (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
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). [Evidence Data] (1) In a skin sensitization test with guinea pigs according to OECD TG 406 on this substance (maximization test, intradermal administration 2%), no dermal reactions were seen, and it was judged as negative for skin sensitization (RAC Background Document (2017)). (2) In a skin sensitization test with guinea pigs (maximization test, intradermal administration 5%), no skin sensitization was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU EFSA (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
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 micronucleus test with bone marrow cells after oral administration to mice (RAC Background Document (2017), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, a chromosomal aberration test, a gene mutation test, and an unscheduled DNA synthesis test using cultured mammalian cells (same as the above).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, EPA classified it in NL (Not Likely To Be Carcinogenic To Humans) (EPA Annual Cancer Report 2019 (Access on November 2020): classified in 1998). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In a carcinogenicity test by 18-month diet administration of this substance to male and female mice, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), severe effects on fetuses were observed at a dose at which maternal toxicity was observed, and therefore, it was classified in Category 1B. In addition, based on new sources of information, the classification results were changed from the previous classification. [Evidence Data] (1) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose (300 mg/kg/day) at which no maternal toxicity was observed, delayed ossification in the sacral/caudal vertebrae was observed in fetuses, and at a dose (1,000 mg/kg/day) at which maternal toxicity (loose stool, reduced body weight gain, a decrease in food consumption) was observed, an increase in mortality, a decrease in fetal weight, an increase in the total number of fetuses with vertebral body/arch malformations (8 fetuses/5 dams, 4.9%), an increase in the total number of fetuses with skeletal malformations (14 fetuses/6 dams), an increase in the incidence of skeletal malformations (8.6%), an increase in the total number of fetuses with delayed ossification of the vertebral body/arch (20 fetuses/9 dams, 12.3%), an increase in the number (22 fetuses/10 dams) and incidence (13.6%) of fetuses with skeletal abnormalities, an increase in skeletal variations (cervical rib, lumbar rib (14 ribs), separated and dumbbell-shaped vertebral bodies), and delayed ossification (the number of fetuses with ossified squamous part of the occipital bone, the number of sternal angles, the number of metacarpal bones, the number of metatarsal bones, and the number of sacral/caudal vertebrae per fetus decreased) were observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, an increase in resorption, body weight loss, and an increase in the number of fetuses and litters with dilatation of the lateral cerebral ventricle, etc., or skeletal variations (abnormalities and delayed ossification of the thoracic vertebra, sternum, and rib) were observed in fetuses at a dose (750 mg/kg/day) at which maternal toxicity (loss of fur, soiling with urine, reduced body weight gain, and decreases in food consumption, and food efficiency) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 19 of gestation, a trend towards higher early embryo mortality (without significant difference) was observed at a dose (150 mg/kg/day) at which maternal toxicity (reduced body weight gain) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). [Reference Data, etc.] (4) In a two-generation reproductive study with rats dosed by feeding, reduced body weight gain and a decrease in food consumption were observed in parent animals at 3,600 ppm, and reduced body weight gain was observed in offspring in a group at the same dose. No effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (5) In the EU CLP classification, it was classified as Repr.1B (Classification in EU CLP (Access on November 2020)).
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 exposure test with rats, at or above 4,000 mg/kg (exceeding Category 2), sedation, soiling with urine, hunchback position, loose stool, ataxia, salivation, red smudge around the eye and nose, and loss of fur were observed in one hour after the exposure (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)). (2) In an acute dermal application test with rats, no symptoms or deaths were observed at 2,000 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)) (3) In a 4-hour inhalation exposure test with rats, at 6.0 mg/L (exceeding Category 2), a decrease in motility, labored breathing, red and pink nasal discharges, wetting around the mouth, and scabs around the eye were observed, but there were no deaths (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2008)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] In (3), effects on the blood were observed in females within the range for Category 2, but only in one sex, and no effects on the blood were observed within the range for Category 2 in other tests, and therefore, these findings were not adopted as the rationale for the classification. Based on (1) to (6), repeated dose toxicity in the oral and dermal routes was considered to be "Not classified," however, since the information on the inhalation route was not obtained, classification was not possible. [Reference Data, etc.] (1) As a result of a 90-day test with rats dosed by feeding, no effect was observed within the range for Category 2, and at 6,400 ppm (males/females: 497/640 mg/kg/day, exceeding Category 2), reduced body weight gain, reduced food efficiency, and pigmentation of the renal tubular epithelial cells in males and females, and increased ALT and creatinine in males were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EU CLP CLH (2017)). (2) As a result of a 90-day oral administration test with dogs, reduced body weight gain in females was observed at 40 mg/kg/day (within the range for Category 2), a decrease in albumin and triglyceride, an increase in liver weight in males and females, and a decrease in food consumption, decreases in red blood cell count, hematocrit, and hemoglobin in females were observed at or above 160 mg/kg/day (exceeding Category 2) (Same as above). (3) As a result of a one-year chronic toxicity study with dogs dosed by gavage, a decrease in total cholesterol in males was observed at or above 10.0 mg/kg/day (within the range for Category 1); reduced body weight gain in males and females, and decreases in red blood cell count, hemoglobin, and hematocrit in females were observed at 40.0 mg/kg/day (within the range for Category 2) (Same as above). (4) As a result of a combined chronic toxicity/carcinogenicity study with rats dosed by feeding, reduced body weight gain in males was observed at 2,500 ppm (males/females: 108/139 mg/kg/day, exceeding Category 2), and reduced body weight gain in females was observed at 5,000 ppm (females: 225 mg/kg/day, exceeding Category 2) (Same as above). (5) As a result of a carcinogenicity study with rats dosed by feeding, reduced body weight gain in males was observed at 7,000 ppm (males/females: 972/1,210 mg/kg/day, exceeding Category 2) (Same as above). (6) In a 21-day dermal toxicity test with rats, as a result of a dermal application of 10 to 1,000 mg/kg/day, only reduced body weight gain was observed (Same as above).
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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