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Latest GHS Classification Results by the Japanese Government (edited by NITE)

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; Bifenthrin
Substance ID	m-nite-82657-04-3_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	Containing no chemical groups with explosive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Classification not possible due to lack of data, though containing unsaturated bonds (olefin).	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available (melting point: 71degC (Agricultural Chemical Registration Data), test temperature: 140degC).	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing fluorine, chlorine and oxygen bound to carbon and hydrogen (but not to other elements)	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no "-O-O-" structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances with melting point of >55degC are not available (melting point: 71degC, Agricultural Chemical Registration Data).	FY2006	GHS Classification Manual （10 Feb, 2006）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	Based on the rat LD50 (oral route) value of 47mg/kg (Agricultural Chemical Registration Data (2004)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Based on the rat LD50 (dermal route) value of 790mg/kg (Agricultural Chemical Registration Data (2001)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Due to the fact that the substance is a solid according to the GHS definition and inhalation of its gas is not expected.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on the rat LC50 (inhalation route) value of 0.8mg/L (Agricultural Chemical Registration Data (2004)).	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on no evidence of irritation observed in rabbit skin irritation tests, reported in Agricultural Chemical Registration Data (1991).	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In rabbit eye irritation tests, mild irritation was found, with a Draize score of <=1 in all affected animals. The effects resolved within 48 hours (Agricultural Chemical Registration Data (1991)).	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on no evidence of mutagenicity observed in any of the following studies: reverse mutation tests on bacteria, forward mutation tests on CHO cells, unscheduled DNA synthesis tests on primary cultured rat hepatocytes, chromosome aberration tests on CHO cells, and chromosome aberration tests on rat bone marrow cells in vivo (Agricultural Chemical Registration Data (1991)).	FY2006	GHS Classification Manual （10 Feb, 2006）
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Not classified	- -	-	-	Based on no evidence of adverse effects on reproduction and offspring development in rat 2-generation reproduction studies and rat/rabbit teratogenicity studies, reported in Agricultural Chemical Registration Data (1991).	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In rat single dose toxicity studies, clinical signs and symptoms including increased response to auditory stimuli, altered locomotor activity, lateral position, clonic convulsions and salivation were seen (Agricultural Chemical Registration Data (2001)). These effects were observed at dosing levels within the guidance value ranges for Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	In dog repeated dose toxicity studies, tremors were noticed (Agricultural Chemical Registration Data (1991)). The effects were observed at dosing levels within the guidance value ranges for Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified into Category 1 from 48 hours EC50=0.11microg/L of the crustacea (Daphnia magna) (Agricultural Chemical Registration Data, 2001).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Since acute toxicity was Category 1 and there was no rapidly degrading (BIOWIN), and since there wasbio-accumulation (log Kow=6 (PHYSPROP Database, 2005)), it was classified into Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
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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