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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	10461-98-0
Chemical Name	2-cyclohexylidene-2-phenylacetonitrile
Substance ID	R02-A-020-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point was 152.3 deg C (969.0 hPa, closed-cup) (ECHA (Accessed July 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 385 deg C (ECHA (Accessed Aug. 2020)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1). [Evidence Data] (1) LD50 for rats: 619 mg/kg (OECD TG 401, GLP) (REACH registration dossier (Accessed Aug. 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402, GLP) (REACH registration dossier (Accessed Aug. 2020))
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] No dead animals were found at 4.792 mg/L within the range for Category 4 in (1), but because effects at a dose near the upper limit for Category 4 are unclear, the classification is not possible. [Evidence Data] (1) LC50 for rats (4 hours): > 4.792 mg/L (OECD TG 403, GLP) (REACH registration dossier (Accessed Aug. 2020))
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 = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 72-hour observation), no skin irritation was seen (erythema/eschar score: 0/0/0, edema score: 0/0/0) (REACH registration dossier (Accessed Aug. 2020)).
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 = 3) (OECD TG 405, GLP, 72-hour observation), 2 animals showed slight conjunctival redness at 1 hour after application but fully recovered within 1 day (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0/1/0, chemosis score: 0/0/0) (REACH registration dossier (Accessed Aug. 2020)).
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), (2). [Evidence Data] (1) It is reported that in a patch test in 47 persons (occlusive, 24-hour application), no skin sensitization was seen (REACH registration dossier (Accessed Aug. 2020)). (2) It is reported that in a maximization test with guinea pigs (n = 10) (OECD TG 406, GLP, intradermal administration: 5% solution), a positive rate was 0% after both 24 and 48 hours (REACH registration dossier (Accessed Aug. 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In an in vivo micronucleus test using the peripheral blood erythrocytes of mice (dosed by gavage), negative results were reported (REACH registration dossier (Accessed Aug. 2020)). (2) In a bacterial reverse mutation test (OECD TG 471), negative results were reported (REACH registration dossier (Accessed Aug. 2020)). (3) In an in vitro mammalian cell gene mutation test (OECD TG 476), negative results (mouse lymphoma cells) were reported (REACH registration dossier (Accessed Aug. 2020)). (4) In a chromosomal aberration test (OECD TG 473), negative results were reported (REACH registration dossier (Accessed Aug. 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), since sedation was observed, it was classified in Category 3 (narcotic effects). [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (OECD TG 401, GLP), sedation, dyspnea, ruffled fur, hunched posture, lying on the stomach, and emaciation were observed at and above 500 mg/kg (within the range for Category 2) (REACH registration dossier (Accessed Aug. 2020)). [Reference Data, etc.] (2) It was reported that in an acute dermal toxicity test with rats (OECD TG 402, GLP), no effects were observed at 2,000 mg/kg (within the range for Category 2) (REACH registration dossier (Accessed Aug. 2020)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (systemic)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1), since the cause of death and target organ could not be identified, it was classified in Category 2 (systemic toxicity) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) It was reported that in a 28-day oral toxicity study with rats dosed by gavage (OECD TG407, GLP), one male and one female died at 200 mg/kg/day (converted guidance value: 62.2 mg/kg/day, within the range for Category 2), but the cause of death could not be identified; and at the same 200 mg/kg/day, a slight increase of the relative liver weight, increased AST/ALT activities (ALT: a 47% increase in females, AST: a 48% increase in males, a 12% increase in females) and decreased TG (27 to 30% decrease) were observed, but no abnormalities were observed in the histopathological examination (REACH registration dossier (Accessed Aug. 2020)).
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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