NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	74222-97-2
Chemical Name	Sulfometuron Methyl
Substance ID	R01-B-053
Classification year (FY)	FY2019
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 (FY2013 revised edition (Ver. 1.1))
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)	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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	There is information that it is combustible (GESTIS (Access on September 2019)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to an element (S) other than carbon or hydrogen. However, the classification is not possible due to no data.
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	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)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) No deaths occurred following administration of 5,000 mg/kg to males and females of rats (ACGIH (7th, 2019)). (2) LD50 for rats: >5,000 mg/kg (EPA Pesticide (2008), HSDB (Access on July 2019))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: >2,000 mg/kg (EPA Pesticide (2008), HSDB (Access on July 2019)) (2) No deaths occurred following administration of 2,000 mg/kg to males and females of rabbits (ACGIH (7th, 2019)).
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Besides, the LC50 values were higher than the saturated vapor pressure concentration (1.1*10-14 mg/L), therefore, the reference values in units of mg/L were applied as the dust. [Evidence Data] (1) Inhalation exposure of rats (4 hours): no deaths occurred at 11,000 mg/m3 (11 mg/L) (ACGIH (7th, 2019)). (2) LC50 for rats (4 hours): >5 ppm (HSDB (Access on July 2019))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) Slight irritation (irritation index 1.3-2.9 (maximum 5)) was reported in a skin irritation test with rabbits (ACGIH (7th, 2019)). [Reference Data, etc.] (2) No irritation was observed in a skin irritation test with rabbits compliant with EPA OPPTS 870.2500 (EPA Pesticide (2005)). (3) In a skin irritation test with guinea pigs on a 50% or 5% suspension in dimethyl phthalate, it was mildly irritating at 50% and not irritating at 5% (ACGIH (7th, 2019)). (4) This substance shows minimal eye irritation and skin irritation, but is not a dermal irritant or a dermal sensitizer (HSDB (Access on July 2019)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1)-(4), it was classified in Category 2B. [Evidence Data] (1) Mild to minimal conjunctivitis was observed in an eye irritation test with rabbits (dose 10 mg), but it resolved within 2 days (ACGIH (7th, 2019)). (2) Slight corneal cloudiness was observed in an eye irritation test with rabbits (dose 61.8 mg (75% formulation)), but the eyes returned to normal within 4 days (ACGIH (7th, 2019)). (3) Very slight irritation was observed in an eye irritation test with rabbits compliant with EPA OPPTS 870.2400 (EPA Pesticide (2008)). (4) This substance shows minimal eye irritation and minimal skin irritation, but is not a dermal irritant or a dermal sensitizer (HSDB (Access on July 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) No sensitization was observed in a skin sensitization test with guinea pigs (ACGIH (7th, 2019)). (2) This substance shows minimal eye irritation and minimal skin irritation, but is not a dermal irritant or a dermal sensitizer (HSDB (Access on July 2019)). (3) No sensitization was observed in a skin sensitization test with rabbits compliant with EPA OPPTS 870.2600 (EPA Pesticide (2008)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there were reports on negative results in a bacterial reverse mutation test and an unscheduled DNA synthesis test with cultured mammalian cells (ACGIH (7th, 2001), EPA Pesticide (2008), HSDB (Access on July 2019)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in A4 by ACGIH (ACGIH (7th, 2019)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), a decrease in the number of births was observed, but parental toxicity was unknown. Therefore, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a 2-generation reproductive toxicity test by feeding with rats, a decrease in the number of pups born was observed in the high dose group over two generations (ACGIH (7th, 2019)). There is no description of parental toxicity in this test. Besides, the test was a two-generation study in 20 animals/group obtained from a 2-year feeding test. Also, in the 2-year feeding test, a decrease in body weight and food consumption, and bile duct hyperplasia and fibrosis in females, and a decrease in erythrocyte counts and hematocrit level in males, were observed at the high doses (ACGIH (7th, 2019)). [Reference Data, etc.] (2) In a developmental toxicity test with rats dosed by feeding, decreased fetal body weight was observed at the dose where maternal toxicity (reduced body weight gain, decreased food consumption) was observed, but no teratogenicity was observed (ACGIH (7th, 2019)). (3) In a developmental toxicity test with rabbits dosed by gavage, no adverse effects on maternal animals and developmental effects on pups were observed (ACGIH (7th, 2019)). (4) In a test in which weaning rats were fed through the maturation period and through the reproductive phase and weaning of the litter, no effects on reproduction and lactation performance were observed (ACGIH (7th, 2019)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] There are no reports on single exposure to this substance in humans. As for experimental animals, there is only a report in (1), and there is no information on the presence or absence of toxic symptoms or necropsy results. Therefore, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) In a single oral administration test with rats, a single dermal administration test with rabbits, or a single 4-hour inhalation exposure test with rats, there were no deaths at doses exceeding the range of Category 2 in all tests (ACGIH (7th, 2019)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, blood system)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1)-(3), since effects on the liver and blood system were observed within the range of Category 2 in oral administration to experimental animals, it was classified in Category 2 (liver, blood system). Information from new information sources was added and reviewed, therefore, the classification result was changed from the previous classification. [Evidence Data] (1) When mice were dosed by feeding for 90 days, clinical data showing hemolysis fluctuated at or above 100 ppm (converted guidance value: 15 mg/kg/day, within the range of Category 2), and splenic erythropoiesis, bile stasis and hepatic cellular cytoplasmic granularity were observed at 7,500 ppm (converted guidance value: 1,125 mg/kg/day, exceeding the range of Category 2) (ACGIH (7th, 2019)). (2) In a 2-year combined chronic toxicity/carcinogenicity study (feeding) with rats, findings of mild hemolysis (decreased erythrocyte counts and hematocrits) in males, and liver fibrosis and bile duct hyperplasia in females were observed at or above 500 ppm (converted guidance value: male/female: 20/26 mg/kg/day, within the range of Category 2) (ACGIH (7th, 2019), HSDB (Access on July 2019)). (3) In a 1-year combined chronic toxicity/carcinogenicity study (feeding) with dogs, decreases in red blood cell count, hemoglobin and hematocrit levels, etc. were observed in females at or above 1,000 ppm (converted guidance value: male/female: 27.5/28.3 mg/kg/day, within the range of Category 2), and at or above 5,000 ppm (converted guidance value: male/female: 152.6/148.5 mg/kg/day, exceeding Category 2), increased serum ALP in males and females, hemosiderin pigmentation of the spleen, etc. in females, and decreases in red blood cell count, hemoglobin and hematocrit levels, atrophy of the prostate, atrophic acini, and testicular degeneration, etc. in males were observed (EPA Pesticide (2008), ACGIH (7th, 2019), HSDB (Access on July 2019)).
10	Aspiration hazard	*	- -	-	-	[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 14-day EC50 = 0.45 microg/L for aquatic plants (Lemna gibba) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2019).
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 as "Not classified" due to being not rapidly degradable (BIOWIN), and 21-day NOEC = 6.1 mg/L for crustacea (Daphnia magna) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2019). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 14-day EC50 = 0.45 microg/L for aquatic plants (Lemna gibba) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2019). By drawing a comparison between the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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