NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-37-6
Chemical Name	1,1-Difluoroethane
Substance ID	m-nite-75-37-6_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)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	The substance is classified into Division 2.1 in UNRTDG (UN1030) and the explosive range is 3.7 - 18% (in air) (SIDS (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified	- -	-	-	Combustible gas	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Low pressure liquefied gas	Warning	H280	P410+P403	Critical temperature is 113.5 degC (Hommel (1996)) exceeding 65 degC.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gaseous substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Classification not possible	- -	-	-	Although there was no mortality even when rats were treated up to 1500 mg/kg and the approximate lethal dose (ALD) was estimated to be >1500 mg/kg (SIDS (2006)), classification was not possible since determination of category was impossible.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	Based on results from 4-hour exposure rat tests in which there was no mortality at up to 319,000 ppm, a mortality ratio of 1/6 at 383,000 ppm and 2/6 at 437,500 ppm, the approximate lethal concentration (ALC) was estimated to be 383000 ppm (SIDS (2006)). The substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. As relevant information, there is a report that vapour irritates the skin (HSDB (2006)), there is no additional detailed data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Although there is a report that vapour irritates the eye (HSDB (2003)), there is no additional detailed data. Classification is not possible due to lack of data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on a negative result in an inhalation rat bone marrow micronucleus test (in vivo somatic cell mutagenicity tests) (OECD TG474) (SIDS (2006)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of a negative Ames test (OECD TG471 (GLP)) and a weak positive in human lymphocytes chromosomal aberration test (OECD TG473) (SIDS (2006), PATTY (5th, 2001)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Classification not possible	- -	-	-	Since there were no exposure related tumors in either sex in a rat 2-year inhalation test, the substance was concluded to be not carcinogenic to rats (SIDS (2006)). However, this result was obtained from a single species, therefore classification was not possible due to lack of data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Classification not possible	- -	-	-	Although there is a report of no maternal or developmental effects observed in a rat developmental test by inhalation during organogenesis period (SIDS (2006)), classification was not possible due to lack of data for sexual function and fertility of parental animals.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	From an experience where good analgesia and an impending loss of consciousness occurred in several volunteers exposed to 50% of the substance for several minutes, the substance has a narcotic effect (PATTY (5th, 2001)). Additionally, lethargy, and unresponsiveness to sound, and loss of righting reflex were observed during inhalation exposure to rats (SIDS (2006)). Based on these effects in humans and animals, the substance was classified into Category 3 (narcotic effects).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 2-month inhalation test with rats at 10,000 ppm/16h (90 day equivalence: 108,866 ppm/6h), no change in clinical observation or necropsy, but microscopic examination revealed a mild diffuse infiltration of small and large round cells in the lung (SIDS (2006)). Additionally, in a 2-week inhalation test with rat at 100,000 ppm/6h, no effects were observed except that the rats appeared to be anesthetized as indicated by sleeping and unresponsiveness to sound during the exposure (SIDS (2006)). However, these effects were observed at the dose level exceeding the upper limit of the guidance value range. Additionally, these tests are incomplete repeat exposure tests because of limited examination items or males only. Therefore, classification was not possible due to lack of data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Not classified	- -	-	-	Classified into Not classified since values estimated by QSAR are 96h-LC50 = 733 mg/L for fish, 48h-EC50 = 720 mg/L for Crustacea, 96h-EC50 = 419 mg/L for algae (SIDS, 2007 for any) and these estimated values are cited by SIDS and therefore reliable under the circumstances where it is difficult to obtain measured value.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified into Not classified since it is not non-water soluble (water solubility: 3200 mg/L (PHYSPROP Database, 2009) and its acute toxicity is Not classified.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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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