GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 83055-99-6
Chemical Name Methyl 2-({[3-(4,6-dimethoxypyrimidin-2-yl)ureido]sulfonyl}methyl)benzoate; Bensulfuron-methyl
Substance ID R02-A-018-METI, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/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)  
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.
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
-
-
- - 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).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
14 Oxidizing solids Classification not possible
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to sulfur, an element other than carbon and hydrogen. 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.
16 Corrosive to metals Classification not possible
-
-
- - No data 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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (OECD TG 401) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), FAO Specifications and Evaluation (2002))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010))
(2) LD50 for rabbits: > 2,000 mg/kg (OECD TG 402) (FAO Specifications and Evaluation (2002))
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), (2).

[Evidence Data]
(1) LD50 for rats: > 5 mg/L (OECD TG 403) (FAO Specifications and Evaluation (2002))
(2) LC50 for rats: > 7.5 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 6) (GLP, 24-hour application to abraded skin and intact skin, 48-hour observation), when irritation changes (erythema/eschar and edema) in the applied parts were scored according to a Draize method immediately after the end of exposure and after 24 hours, all was 0 (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits (n = 9) (GLP, washed eyes for 3 animals, un-washed eyes for 6 animals, 72-hour observation), no eye irritation was seen (corneal opacity score: 0/0/0/0/0/0/0/0/0, iritis score: 0/0/0/0/0/0/0/0/0, conjunctival redness score: 0/0/0/0/0/0/0/0/0, chemosis score: 0/0/0/0/0/0/0/0/0) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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). Besides, no information other than the classification result was obtained from knowledge in (2).

[Evidence Data]
(1) It is reported that in a skin irritation test and a skin sensitization test with guinea pigs (n = 10) (intradermal administration: 1.0% suspension), no skin reactions were seen 24, 48 hours after challenge (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).

[Reference Data, etc.]
(2) It was classified as Skin Sens. 1 in EU CLP CLH.
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (7), it was classified as "Not classified."

[Evidence Data]
(1) In a chromosomal aberration test using bone marrow cells from rats, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EFSA (2008)).
(2) In a micronucleus test using bone marrow cells from rats, negative results were reported (FAO Specifications and Evaluation (2002)).
(3) In a bacterial reverse mutation test, negative results were reported (FAO Specifications and Evaluation (2002), EFSA (2008), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)).
(4) In an in vitro mammalian cell gene mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010)).
(5) In a mammalian cell (CHO) sister chromatid exchange test, positive (S9-) or negative (S9+) results were reported (FAO Specifications and Evaluation (2002), EFSA (2008)).
(6) In a chromosomal aberration test using human lymphocytes, negative results were reported (FAO Specifications and Evaluation (2002)).
(7) In a UDS assay using primary rat hepatocytes, negative results were reported (FAO Specifications and Evaluation (2002), EFSA (2008)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for classification results by domestic and international organizations, EPA reported that the substance was classified as NL (Not likely to be carcinogenic to humans) (EPA Human Risk Assessment (2015)).
(2) In a 2-year combined chronic toxicity/carcinogenicity study with rats and mice (dosed by feeding), no treatment-related increase of tumorigenesis was observed in either species (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Risk Assessment (2015), EFSA (2008)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified." In (4), complete fetal resorption was observed at 1,500 mg/kg/day, but since the maternal mortality was 10%, it was considered to be inappropriate to use the finding for classification.

[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, 2010), EPA Human Risk Assessment (2015)).
(2) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, only transient reduced body weight gain was observed in F1 offsprings and no effects on fertility were observed at 7,500 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Risk Assessment (2015)).
(3) It was reported that in a developmental toxicity study with rats dosed by gavage, delayed ossification of the hyoid bones was observed in pups at 500 mg/kg/day at which no general toxicity was observed in F0 parental animals, and lower body weight and delayed ossification of the lumbar ribs, hyoid bones, and sternebrae were observed but no teratogenicity was observed at 1,320 mg/kg/day (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Risk Assessment (2015)).
(4) It was reported that in a developmental toxicity study with rabbits dosed by gavage, at 1,500 mg/kg/day, deaths (accidental deaths, 2/20 rabbits), abortion (1 case), reduced body weight gain, lower body weight, reduced food consumption, and complete fetal resorptions were observed in parental animals, while only lower body weight but no teratogenicity was observed in pups (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Risk Assessment (2015)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
Based on (1), in the oral, dermal and inhalation routes, it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in all of an acute oral toxicity test with rats (OECD TG 401), an acute dermal toxicity test with rats or rabbits (OECD TG 402), and an acute inhalation (dust) toxicity test with rats (OECD TG 403), there were no incidence of death and no marked signs at doses at the upper limit of Category 2 or exceeding the range of Category 2 (FAO Specifications and Evaluation (2002), EPA Human Health Risk Assessment (2015)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) to (6), it was considered to be classified as "Not classified" in the oral route, but there was no information on toxicity in the other routes. Therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, no effects were observed at doses up to 1,500 ppm (93 mg/kg/day (males), 111 mg/kg/day (females), within the range for Category 2), and reduced staining of liver cytoplasm (males) and a slight increase of cholesterol levels (males) were observed at 7,500 ppm (475 mg/kg/day (males), 567 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Health Risk Assessment (2015)).
(2) It was reported that in a 90-day oral toxicity test with mice dosed by feeding, no adverse effects were observed at doses up to 1,000 ppm (132 mg/kg/day (males), 133 mg/kg/day (females), in the range corresponding to "Not classified"), and liver effects (centrilobular hepatocyte hypertrophy) were observed at 3,000 ppm (387 mg/kg/day (males), 407 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Health Risk Assessment (2015)).
(3) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding, no effects were observed at doses up to 1,000 ppm (32 mg/kg/day (males), 37 mg/kg/day (females), within the range for Category 2), and liver effects (elevated ALP/ALT activities, increased weight), gallbladder calculus and other signs were observed at 10,000 ppm (341 mg/kg/day (males), 359 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Health Risk Assessment (2015)).
(4) It was reported that in a 52-week oral toxicity test with dogs dosed by feeding, no effects were observed at doses up to 750 ppm (21.4 mg/kg/day (males), 19.9 mg/kg/day (females), within the range for Category 2), and liver effects (elevated ALP/ALT activities, increased weight, brown pigment in the biliary canaliculi) were observed at 7,500 ppm (237 mg/kg/day (males), 223 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Health Risk Assessment (2015)).
(5) It was reported that in a combined chronic toxicity/carcinogenicity study with rats dosed by feeding, no effects were observed at doses up to 750 ppm (30 mg/kg/day (males), 40 mg/kg/day (females), within the range for Category 2), and liver effects (centrilobular hepatocyte hypertrophy, basophilia in the peripheral part of the cytoplasm in the liver), etc. were observed at 7,500 ppm (309 mg/kg/day (males), 405 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Health Risk Assessment (2015)).
(6) It was reported that in a combined chronic toxicity/carcinogenicity study with mice dosed by feeding, no effects were observed at doses up to 2,500 ppm (226 mg/kg/day (males), 227 mg/kg/day (females), in the range corresponding to "Not classified"), and liver effects (centrilobular hepatocyte hypertrophy) in males and kidney effects (increased renal cortical cyst) and liver effects (increased weight) in females were observed at 5,000 ppm (455 mg/kg/day (males), 460 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2010), EPA Human Health Risk Assessment (2015)).
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 = 0.0574 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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 NOEC = 0.04 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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 because it is not rapidly degradable (BIOWIN) and due to 72-hour ErC50 = 0.0574 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
From 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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