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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	82657-04-3
Chemical Name	2-Methyl-1,1'-biphenyl-3-ylmethyl (Z)-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate
Substance ID	R03-C-064-MHLW
Classification year (FY)	FY2021
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	-	- -	-	-	-
2	Flammable gases	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-
17	Desensitized explosives	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1B. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a maximization test (OECD TG 406, intradermal induction: 5% solution) with guinea pigs (n=10), the positive rate was 89% (8/9 animals, one animal died during the process) (ECHA RAC Opinion (2011), CLH Report (2009)). [Reference Data, etc.] (2) The results were negative by the Buehler method, but the results were positive by the maximization method (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), JMPR (2009)). (3) It was reported that, in a skin sensitization test (dermal administration: undiluted solution) by the Buehler method with guinea pigs (n=10), no dermal sensitization was observed (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (4) In the EU, it was classified in Skin Sens. 1B (EU-CLP Classification Results (Accessed Jan. 2022)).
5	Germ cell mutagenicity	-	- -	-	-	-
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), an increase in the incidence of urinary bladder tumors was suggested, but since it was a result only for one animal species and one sex (male mice) derived from a single test, it was considered to be limited evidence of carcinogenicity and insufficient for classification in Category 1B, and therefore, it was classified in Category 2. It was classified based on the new information source. [Evidence Data] (1) In a carcinogenicity study with mice dosed by feeding for two years, at 50 to 600 ppm (7.6 to 92 mg/kg/day (males), 10 to 110 mg/kg/day (females)), a significant increase or a trend towards an increase in the incidence of liver tumors (combined hepatocellular adenomas and adenocarcinomas) in males, lung tumors (combined bronchiolar/alveolar adenomas and bronchiolar/alveolar carcinomas) in females, and urinary bladder tumors (leiomyosarcomas) in males was observed (JMPR (2009)). (2) As a result of re-evaluation by an expert panel of pathologists, it was concluded that the liver tumors and lung tumors in (1) were not related to the administration. Also, as for (2), the Food Safety Commission of Japan judged that the liver tumors were not the effects of the administration of the test substance because there was no statistically significant increase and they were not accompanied by precancerous lesions, either, and that the lung tumors were not the effects of the administration of the test substance because the strain of mice (Swiss Webster) used was a strain in which lung tumors of this type occurred most frequently, and the increased incidence in the dose group was also within the background data and was not dose-dependent, etc. (JMPR (2009), Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019)). (3) As for the increase in the incidence of urinary bladder tumors (leiomyosarcomas) observed in a high-dose group of male mice in (1), in the above re-evaluation by an expert panel of pathologists, the JMPR judged that the urinary bladder tumors in mice were benign, probably vascular in origin, occurred predominantly in males, apparently occurred only in mice and had no relevance for humans. On the other hand, the Food Safety Commission of Japan concluded that an increase in the incidence of leiomyosarcomas (submucosal tumors) was observed in the urinary bladder of male mice, but it was difficult to consider the mechanism of tumor formation as genotoxic, and that it was considered possible to set a threshold for assessment, and it did not deny the relationship between urinary bladder tumors and the administration of the test substance (JMPR (2009), Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019)). (4) The EU concluded that the possibility that both urinary bladder tumors and liver tumors observed in male mice were related to the administration of the test substance could not be ruled out, and there was no clear evidence that they had no relevance for humans, and it adopted these tumor incidences as the rationale for the carcinogenicity classification by the EU (ECHA RAC Opinion (2011)). (5) As for the classification results by domestic and international organizations, the EPA classified this substance in Group C (Possible Human Carcinogen) (EPA OPP Annual Cancer Report (2020)), and the EU classified it in Carc. 2 (EU-CLP Classification Results (Accessed Jan. 2022)). [Reference Data, etc.] (6) In a carcinogenicity study with rats dosed by feeding for two years, at 12 to 200 ppm (2.3 to 9.7 mg/kg/day (males), 3.0 to 12.7 mg/kg/day (females)), there was no increase in the incidence of tumors up to the highest dose of 200 ppm at which general toxicity (tremor, decreased body weight gain) appeared (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), JMPR (2009), ECHA RAC Opinion (2011)).
7	Reproductive toxicity	-	- -	-	-	-
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

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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