NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	109-78-4
Chemical Name	Ethylene cyanhydrin
Substance ID	m-nite-109-78-4_v1
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)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" from a flash point of 128 deg C (closed cup) (GESTIS (Access on Sep. 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 494 deg C (ICSC (2001)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 (Not applicable)." Besides, there is information that it reacts with water to produce highly toxic fumes (including hydrogen cyanide) (ICSC (2001)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 3,200 mg/kg (EPA PPRTV (2012), HSDB (Access on October 2019)) (2) LD50 for rats: 10 g/kg (10,000 mg/kg) (PATTY (6th, 2012), HSDB (Access on October 2019)) (3) LD50 for rats: 3,200-6,400 mg/kg (PATTY (6th, 2012))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: >3.8 g/kg (3,800 mg/kg) (PATTY (6th, 2012)) (2) LD50 for rabbits: 5,000 mg/kg (HSDB (Access on October 2019))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), since the category could not be specified, it was classified as "Classification not possible." [Evidence Data] (1) An inhalation test with rats (8 hours): There were no dead animals at the saturated vapor concentration (0.306 mg/L) (converted 4-hour equivalent value: 0.612 mg/L) (PATTY (6th, 2012)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." The category was changed due to the new data obtained. [Evidence Data] (1) In a test in which this substance (520 mg) was applied under non-occlusive conditions to the skin of rabbits, slight irritation was observed (GESTIS (Access on October 2019)). (2) No irritation was observed in a test in which a cloth soaked with this substance was applied to the skin of rabbits for 15 minutes or 20 hours (GESTIS (Access on October 2019), REACH registration dossier (Access on November 2019)). (3) In a skin irritation test in which this substance was applied occlusively to rabbits for 72 hours according to the Draize method, the primary irritation indices (PII) were 0.17 (erythema) and 0 (edema) (REACH registration dossier (Access on November 2019)). [Reference Data, etc.] (4) In a test in which this substance (3.8 g/kg) was applied to the skin of rabbits, it showed moderate irritation (GESTIS (Access on October 2019)). (5) Single application of this substance to rabbits caused moderate irritation (PATTY (6th, 2012)). (6) In a study in which 0, 0.1, 0.2, or 0.5 mL this substance was applied to the skin of guinea pigs, an appearance of pain at the application site was observed, but irritation was slight (EPA PPRTV (2012)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, the category was changed due to the new data obtained. [Evidence Data] (1) In an eye irritation test (the Draize method) with rabbits of this substance, the mean scores for corneal opacity, iritis, conjunctiva redness and conjunctiva chemosis at 24/48/72 hours were 0, 0, 0.83 and 0.28, respectively, and all of these were fully reversible within 72 hours (REACH registration dossier (Access on November 2019)). [Reference Data, etc.] (2) Application of this substance (one drop: 50 mg) to the eyes of rabbits caused severe irritation, and vascular injection with formation of edema or necrotic changes in blood vessels were observed from 10 minutes to 8 days after application (GESTIS (Access on October 2019)). (3) This substance might cause irritation to the eyes (HSDB (Access on October 2019)). (4) This substance showed irritation to the mucous membranes following contact (GESTIS (Access on October 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a mouse local lymph node assay (LLNA) according to OECD TG 429, SI values were below 3, and it was judged to be negative (REACH registration dossier (Access on November 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, negative results were reported in bacterial reverse mutation tests (NTP DB (Access on October 2019), EPA PPRTV (2012)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as I (Inadequate Information to Assess Carcinogenic Potential) in the provisional evaluation by EPA (EPA PPRTV (2012)). [Reference Data, etc.] (2) In a combined chronic toxicity/carcinogenicity study in which rats and mice were given this substance by feeding for 78 weeks, no increase in the incidence of neoplastic lesions was observed. However, the duration of this study was shorter (normally 104 weeks), and it was considered to be insufficient information to evaluate the carcinogenicity of this substance (EPA PPRTV (2012)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), as for the oral route, no effects were observed within the guidance range for Category 2 by administration to experimental animals. Therefore, it was classified as "Not classified." As for other routes, no data were available, and it was classified as "Classification not possible." [Evidence Data] (1) In a 78-week feeding toxicity study with male rats, reduced body weight gain was observed at or above 100 ppm (7 mg/kg/day, within the range of Category 1), and decreased red blood cell counts, white blood cell counts, and hemoglobin and hematocrit levels were observed at 3,000 ppm (221 mg/kg/day, exceeding Category 2) (EPA PPRTV (2012), HSDB (Access on October 2019)). (2) In a 78-week feeding toxicity study with male mice, reduced body weight gain was observed at 3,000 ppm (539 mg/kg/day, exceeding Category 2) (EPA PPRTV (2012), HSDB (Access on October 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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