NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	63935-38-6
Chemical Name	alpha-cyano-3-phenoxybenzyl 2,2-dichloro-1-(4-ethoxyphenyl)cyclopropanecarboxylate; Cycloprothrin
Substance ID	R02-B-118-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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Classification not possible	- -	-	-	No data available.
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to heat at up to 150 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not 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)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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	- -	-	-	No data 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). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Japanese Journal of Pesticide Science Vol. 16, No. 4 (Pesticide Science Society of Japan, 1991))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Japanese Journal of Pesticide Science Vol. 16, No. 4 (Pesticide Science Society of Japan, 1991))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (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)	Classification not possible	- -	-	-	[Rationale for the Classification] The category could not be determined from (1), and it was classified as "Classification not possible." [Evidence Data] (1) LC50 for rats (4 hours): > 1.5 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) In a skin irritation test with rabbits on a solution of this substance in acetone (0.5 g, 24-hour closed patch), scores were all 0, and no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Japanese Journal of Pesticide Science Vol. 16, No. 4 (Pesticide Science Society of Japan, 1991)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] There was a description of (1), but the classification was not possible. Because it was a test result by application of not the undiluted substance but a 10% suspension, the classification result was changed. [Reference Data, etc.] (1) In an eye irritation test with rabbits on a 10% suspension of this substance, no changes in the cornea or iris were seen, and slight conjunctival redness was observed from 1 hour after application but disappeared 48 hours after application (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Japanese Journal of Pesticide Science Vol. 16, No. 4 (Pesticide Science Society of Japan, 1991)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1). [Evidence Data] (1) Skin sensitization tests with guinea pigs (an open epicutaneous test (OET) and a maximization test, intradermal administration 5%) were conducted, and it was reported to be negative in OET but positive (positive rate 70%) in a maximization test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Japanese Journal of Pesticide Science Vol. 16, No. 4 (Pesticide Science Society of Japan, 1991)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for in vivo, it was reported to be negative in a micronucleus test with bone marrow cells after gavage administration to mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, a chromosomal aberration test and a gene mutation test using cultured mammalian cells (same as the above). (3) It is reported that this substance was considered to have no genotoxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There were no classification results by domestic and international organizations. There were no available reports in humans. It was classified in Category 2 from (1), (2). The classification result was changed based on carcinogenicity test results in experimental animals. [Evidence Data] (1) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, no neoplastic lesions with treatment-related increases in incidence were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female mice, significant increases in the incidences of hepatocellular adenoma and carcinoma in males and a significant increase in the incidence of hepatocellular adenoma or carcinoma (combined) in males and females were found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a two-generation reproductive study with rats dosed by feeding, no effect on offspring or fertility was observed even at the maximum dose at which general toxicity in parent animals (increases in absolute and relative liver weight in P-generation females and F1-generation males of a group treated at 1,000 ppm) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In a developmental toxicity study with female rats dosed by gavage on days 7 to 17 of gestation, salivation, a tendency of reduced body weight gain, etc. in the dams, and delayed ossification in fetuses at 200 mg/kg/day; and an increase in absolute liver weight in the dams, and convoluted ureters in fetuses at 2,000 mg/kg/day were observed, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, no toxicity effects were observed in either dams or fetuses at the highest dose (2,250 mg/kg/day) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] There was no report on effects of acute exposure to this substance in humans. In test animals, based on (1) to (3), in the oral and dermal routes, no findings that could identify target organs within the range for Category 1 and Category 2 were obtained, and it was classified as "Not classified." Based on (4), in the inhalation route, effects on the testis and lungs were considered to be incidental findings, and other symptoms were considered to be non-specific symptoms due to inhalation exposure, and therefore, they were not adopted as target organ toxicity. Therefore, it was determined that classification was not possible. As a result of a review using the new information source, the classification result was changed from the previous classification. [Evidence Data] (1) In an acute oral toxicity test with rats, no symptoms or deaths were observed at 5,000 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) In an acute dermal application test with rats, no symptoms or deaths were observed at 5,000 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (3) In a general pharmacological test (oral dose) with mice, central nervous system stimulant effects (restlessness, spasms, gait abnormalities, and loss of motor coordination) were observed at 5,000 mg/kg (exceeding Category 2), and also in other tests with mice, loss of motor coordination due to spasms was observed at 5,000 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (4) In a 4-hour inhalation exposure test (mist, systemic exposure) with rats, face washing behavior, a decrease in locomotor activity, lacrimation, nasal discharge, salivation, abdominal breathing, loss of response to sound, lying on side, epistaxis, staining of the muzzle and urethral opening, bleeding trace around the eye, and loss of fur were observed at or above 0.5 mg/L (within the range for Category 1). In a gross pathological examination, testicular atrophy (1/10 animals), miliary brown spots in the lung (2/10 animals), and slight liver piece-like degeneration in the lung (1/10 animals) were observed in males at 1.5 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (reproductive organs (male))	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (reproductive organs (male)). As a result of a review based on the new information, the classification results were changed from the previous classification. [Evidence Data] (1) As a result of a 6-month oral toxicity test with dogs, reduced body weight gain and vomiting in males and females, and atrophy of the prostate in males were observed at or above 50 mg/kg/day (within the range for Category 2); and decreases in dhemoglobin, hematocrit, and erythrocyte count, an increase in platelet count, a decrease in albumin, and an increase in liver weight were observed in males and females at 500 mg/kg/day (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) As a result of a one-year oral toxicity test with dogs, an increase in the incidence of vomiting and an increase in thyroid weight in males and females, and a decrease in discharges due to prostate acinar collapse, and decreases in absolute and relative prostate weight in males were observed at 100 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). [Reference Data, etc.] (3) As a result of a 90-day test with rats dosed by feeding, a decrease in serum cholinesterase (ChE), an increase in liver weight in males and females, and an increase in BUN and an increase in kidney weight in females at 1,000 ppm (males/females: 587/589 mg/kg/day, exceeding Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (4) As a result of a 90-day test with rats dosed by feeding, scabbing that was thought to be due to skin sensitization in females at or above 1,000 ppm (males/females: 61.3/71.1 mg/kg/day, within the range for Category 2), and external injury, a decrease in locomotor activity, and low grip strength of the forelimbs and hindlimbs in males and females, and reduced body weight gain and a decrease in food consumption in males at 10,000 ppm (males/females: 609/675 mg/kg/day, exceeding Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (5) As a result of two-year tests with rats and mice dosed by feeding, the only effect observed within the range for Category 2 was hepatocyte hypertrophy which was observed at or above 500 ppm (males/females: 86.6/102 mg/kg/day) (within the range for Category 2, or exceeding Category 2) in a test with mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 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)	-	- -	-	-	-
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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