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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	420-46-2
Chemical Name	1,1,1-Trifluoroethane
Substance ID	R01-B-094
Classification year (FY)	FY2019
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	FY2009
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	It was classified in Category 1 based on a lower explosion limit of 7.1 vol% (GESTIS (Access on Sep. 2019)). Besides, it is classified in Division 2.1 in UNRTDG (UN2035).
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	It was classified as "Not classified" because it is classified in Division 2.1 in UNRTDG (UN2035), and Division 5.1 is not assigned, including Subsidiary Risk.
5	Gases under pressure	Low pressure liquefied gas	Warning	-	-	It was classified as low-pressure liquefied gases from a critical temperature of 345.89 K (72.9 deg C, HSDB (Access on October 2019)).
6	Flammable liquids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to gas substances are not available.
17	Desensitized explosives	*	- -	-	-	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)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) LC50 for rats: > 540,000 ppm (PATTY (6th, 2012), ECETOC JACC 52 (2006), HSDB (Access on September 2019)) (2) LC50 for rats: > 591,000 ppm (PATTY (6th, 2012), SIDS (2012)) (3) LC50 for rats: > 600,000 ppm (ECETOC JACC 52 (2006))
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Although there are descriptions of (1) and (2), it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) No irritation study was conducted with this substance, but no signs of irritation were observed in a 90-day repeated inhalation toxicity test in which rats were given whole-body exposure to this substance (up to 40,000 ppm (137,000 mg/m3)) (ECETOC JACC 52 (2006), GESTIS (Access on September 2019)). (2) It is reported that no irritation was observed in volunteers who were exposed to air containing this substance (HSDB (Access on September 2019)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Although there are descriptions of (1) and (2), it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) No irritation study was conducted with this substance, but no signs of irritation were observed in a 90-day repeated inhalation toxicity test in which rats were given whole-body exposure to this substance (up to 40,000 ppm (137,000 mg/m3)) (ECETOC JACC 52 (2006), GESTIS (Access on September 2019)). (2) It is reported that no irritation was observed in volunteers who were exposed to air containing this substance (HSDB (Access on September 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Because all standard combination tests including in vivo and in vitro tests were negative. [Evidence Data] (1) As for in vivo, there was a report of it being negative in a mouse bone marrow micronucleus test (ECETOC JACC 52 (2006), PATTY (6th, 2012), SIDS (2012)). (2) As for in vitro, there are reports of it being negative in bacterial reverse mutation tests and a chromosomal aberration test with human lymphocytes (ECETOC JACC 52 (2006), PATTY (6th, 2012), SIDS (2012)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There are no available reports in humans. The test in (1) had only one dose, the duration of administration was shorter than that of the standard guideline, and there was no information on carcinogenicity by the inhalation route, which is the main exposure route for this substance. Therefore, Classification not possible due to lack of data. [Evidence Data] (1) In a study in which rats were given this substance by gavage for 52 weeks and then observed for 72 weeks, no treatment-related neoplastic lesions were found (SIDS (2012), PATTY (6th, 2012)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), no developmental effects were observed, but there were no data on effects on sexual function and fertility in parental animals. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) No developmental effects were observed in a developmental toxicity test in which female rats were exposed by inhalation at concentrations up to 40,000 ppm (4%) on Days 7 to 16 of gestation (ECETOC JACC.52 (2006), SIDS (2012), PATTY (6th, 2012)). (2) No developmental effects were observed in a developmental toxicity test in which female rabbits were exposed by inhalation at concentrations up to 40,000 ppm (4%) on Days 6 to 18 of gestation (ECETOC JACC.52 (2006), SIDS (2012), PATTY (6th, 2012)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), since no toxicity effects were observed after inhalation exposure of rats at concentrations exceeding the range of Category 2, it was classified as "Not classified." [Evidence Data] (1) There is a report that in a single 4-hour inhalation exposure test with rats, at up to 591,000 ppm (exceeding the range of Category 2), there was no lethality nor were there any gross observations of abnormalities seen during the gross necropsy (ECETOC JACC 52 (2006), SIDS (2012)). [Reference Data, etc.] (2) There is a report that 9 male volunteers were exposed to 500 ppm of this substance for 2 hours, however, no effects were seen in the electrocardiographic monitoring, and irritative and central nervous system symptoms (ECETOC JACC 52 (2006), SIDS (2012)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), since no toxicity effects were observed after inhalation exposure of rats at concentrations exceeding the range of Category 2, it was classified as "Not classified." [Evidence Data] (1) In a 13-week inhalation exposure test with rats, as a result of whole-body exposure at concentrations of 2,000-40,000 ppm (6 hours/day, 5 days/week), no treatment-related effects were seen at up to 40,000 ppm (converted guidance value: 28,571 ppm, exceeding the range of Category 2) (ECETOC JACC 52 (2006), SIDS (2012)). [Reference Data, etc.] (2) In a 4-week inhalation exposure test with rats, as a result of nose-only inhalation exposure at 2,000-39,000 ppm (6 hours/day, 5 days/week), 1 animal from each exposure group died, and a decrease in testicular weight, small testes and degenerative changes in the testes were observed. In this test, the animals had suffered heat stress due to the design of the nose-only exposure unit (ECETOC JACC 52 (2006)). (3) In a 28-day inhalation exposure test with rats executed to confirm the results of (2), as a result of whole-body exposure (6 hours/day, 5 days/week), effects on testis were not observed at up to 40,000 ppm (ECETOC JACC 52 (2006), SIDS (2012)).
10	Aspiration hazard	*	- -	-	-	[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)	Not classified	- -	-	-	It was classified as "Not classified" from 48-hour EC50 = 300 mg/L for crustacea (Daphnia magna) (SIDS, 2012).
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not rapidly degradable (BIOWIN), and due to a low bioaccumulation estimate (log Kow = 1.15 (the web site of the Ministry of Economy, Trade and Industry (METI), 2019)), and classification as "Not classified" 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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