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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	75-68-3
Chemical Name	1-Chloro-1,1-difluoroethane; HCFC-142b
Substance ID	R02-B-060-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
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)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	It was classified in Category 1 based on a lower flammable limit of 6.2 vol% and an upper flammable limit of 18 vol% (HSDB (Access on May 2020)). Besides, it is classified in Division 2.1 in UNRTDG (UN2517).
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified	- -	-	-	It was classified as "Not classified" because it was classified in Category 1 for flammable gases.
5	Gases under pressure	Low pressure liquefied gas	Warning	-	-	It was classified as low-pressure liquefied gases based on a critical temperature of 136.85 deg C (HSDB (Access on May 2020)).
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to gas substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	Gas (GHS definition). 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 (EHC 139 (1992))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LC50 for rats (4 hours): 128,000 ppm (SIAR (2004), EHC 139 (1992)) (2) LC50 for rats (4 hours): 2,050 mg/L (498,731 ppm) (Environmental Risk Assessment for Chemical Substances vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008))
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified."
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] There were descriptions of (1), (2), but because it was not sufficient information for the category, the classification was not possible. Besides, there is a risk of frostbite, but because this substance was not applicable to refrigerated liquefied gas, H281 (may cause cryogenic burns or injury) was not applied. [Reference Data, etc.] (1) This substance is a gas at room temperature. Therefore, a skin irritation test is not applied to it (SIAR (2004)). (2) When liquid of this substance contacts with the skin or enters the eye, it causes frostbite (Environmental Risk Assessment for Chemical Substances vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] There were descriptions of (1), (2), but because it was insufficient information for the category, the classification was not possible. Data that were the rationale in the previous classification were not considered as sufficient information for the category either. Therefore, the classification result was changed. Besides, there is a risk of frostbite, but because this substance was not applicable to refrigerated liquefied gas, H281 (may cause cryogenic burns or injury) was not applied. [Reference Data, etc.] (1) In an eye irritation test in which liquefied form of this substance was applied to the rabbit eye, no effects were seen in the cornea and iris, but slight conjunctival edema and discharge were observed. However, due to a boiling point of this substance of -9 deg C, it boiled out of the eye immediately after the application, and the results did not constitute evidence of effects in humans well (SIAR (2004), GESTIS (Access on May 2020)). (2) When liquid of this substance contacts with the skin or enters the eye, it causes frostbite (Environmental Risk Assessment for Chemical Substances vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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 chromosomal aberration test with rats bone marrow cells after 13-week inhalation exposure and negative in a heritable mutagenicity test (dominant lethal test) by 15-week inhalation exposure (SIAR (2004), MAK (DFG) vol.1 (1991), EHC 139 (1992)). (2) As for in vitro, it was reported to be negative and positive in bacterial reverse mutation tests (SIAR (2004), EHC 139 (1992)), and negative and positive in cell transformational tests with cultured mammalian cells (SIAR (2004)). (3) It was assessed in OECD SIAR that this substance did not pose a significant genotoxic hazard to humans (SIAR (2004)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There was no available report in humans. Negative results were reported in rats from (1), but because carcinogenicity test results in mice were not obtained, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In a combined chronic toxicity/carcinogenicity test by 104-week inhalation exposure of male and female rats to this substance, no treatment-related increase in tumor incidences was observed (SIAR (2004), EHC 139 (1992)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), although the possibility of developmental effects was considered to be low, there was no information on sexual function and fertility, and classification was not possible due to lack of data. The evidence data was reviewed and the classification results were changed from the previous classification. [Evidence Data] (1) In a developmental toxicity study by inhalation exposure of female rats on days 6 to 15 of gestation, maternal toxicity was not observed, and reduced ossification (interparietal and supraoccipital bones of the skull, and the hyoid bone) was observed in fetuses, although no dose-related trends in incidence were apparent (IRIS (1995), Environmental Risk Assessment for Chemical Substances Vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). [Reference Data, etc.] (2) It was reported that, in a developmental toxicity study by inhalation exposure of female rats on days 4 to 13 or 6 to 15 of gestation, maternal toxicity was unknown and an increase in pre-implantation embryo loss was observed, but it was not dose-dependent (Environmental Risk Assessment for Chemical Substances Vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). The IRIS (1995) stated that the method and the report of this study were insufficient. (3) The result of a dominant lethal assay in which male rats were exposed by inhalation for 15-weeks was negative (SIAR (2004)).
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] There was no report on single exposure to this substance in humans. Based on (1) and (2), it was classified in Category 3 (narcotic effects, respiratory tract irritation). A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In mice and rats exposed to high concentration of this substance, death or narcotic effects were observed (EHC 139 (1992)). (2) In a 6-hour acute inhalation exposure of rats, LC50 was above 1,640,000 mg/m3 (400,000 ppm) (converted 4-hour equivalent value: 489,898 ppm (exceeding Category 2)), and inflammation in the lung and central nervous system depression were observed at high concentrations (SIAR (2004)). [Reference Data, etc.] (3) It was reported that, in a test by a single administration of this substance by inhalation to dogs, cardiac sensitization was observed, and EC50 was 2,050,000 mg/m3 (498,731 ppm) (SIAR (2004)). (4) Chlorofluorocarbon compounds were known to sensitize the heart and increase sensitivity to adrenaline-induced arrhythmia (EURAR (2007)（CAS RN 75-45-6)).
9	Specific target organ toxicity - Repeated exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), no toxic effects were observed in test animals in an inhalation exposure test at concentrations far exceeding Category 2. Although information on repeated dose toxicity in the oral and dermal routes was not available, since this substance was a gas and the primary route of exposure was by inhalation, it was classified as "Not classified." [Evidence Data] (1) In a 90-day (6 hours/day, 5 days/week) test by inhalation exposure of rats in concentrations of 1,000 and 10,000 ppm (exceeding Category 2 in both cases), no exposure-related effects were observed (EHC 139 (1992), MAK (DFG) vol.1 (1991), IRIS (1995), SIAR (2004), Environmental Risk Assessment for Chemical Substances Vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). (2) In a 90-day (6 hour/day, 5 day/week) test by inhalation exposure of dogs in concentrations of 1,000 and 10,000 ppm (exceeding Category 2 in both cases), no exposure-related effects were observed (MAK (DFG) vol.1 (1990), SIAR (2004), Environmental Risk Assessment for Chemical Substances Vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)). (3) In a 104-week (6 hour/day, 5 day/week) test by inhalation exposure of rats in concentrations of 20,000 ppm (exceeding Category 2), no exposure-related effects were observed (IRIS (1995), SIAR (2004), Environmental Risk Assessment for Chemical Substances Vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008)).
10	Aspiration hazard	Not classified	- -	-	-	[Rationale for the Classification] Gas (GHS definition)

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 36 mg/L for fish (Oncorhynchus mykiss) (EHC 139, 1992).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it was not rapidly degradable (a 28-day degradation rate by BOD, OECD TG301D: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1991)), and it was classified in Category 3 in acute toxicity.
12	Hazardous to the ozone layer	Category 1	Warning	H420	P502	This substance is listed in the Annexes to the Montreal Protocol.

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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