NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	151-67-7
Chemical Name	2-Bromo-2-chloro-1,1,1-trifluoroethane (Halothane)
Substance ID	m-nite-151-67-7_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified	- -	-	-	It is not combustible (ICSC (2003)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified	- -	-	-	It is not combustible (ICSC (2003)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2003)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing fluorine and chlorine (but not oxygen) which are chemically bonded only to carbon or hydrogen.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to low-temperature-boiling liquids are not available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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	- -	-	-	Classification not possible due to lack of data. Besides, although there was a report of an LD50 value of 5,680 mg/kg for rats (GESTIS (Access on September 2014), RTECS (Access on September 2014)), each was an information source in List 3 and it was not possible to confirm by an original source, therefore, it was not adopted for classification. A new information source (GESTIS (Access on September 2014)) was added, and the category was revised.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on reports of an LC50 value (4 hours) of 120,000 mg/m3 (14,880 ppm) for rats (RTECS (Access on September 2014)), and of an LC50 value (10 minutes) of 22,000 ppm (converted 4-hour equivalent value: 4,510 ppm) for mice (Sax's Dangerous Properties of Industrial Materials (2012)), it was classified in Category 4. Besides, since the LC50 values were lower than 90% of the saturated vapor concentration (319,842 ppm), the reference value in units of ppm was applied as a vapour without a mist. New information sources (RTECS (Access on September 2014), Sax's Dangerous Properties of Industrial Materials (2012)) were added, and the category was revised. Besides, although RTECS was the information source listed in List 3 and it was not possible to confirm by an original source, this substance is used as a pharmaceutical substance, therefore, it was classified including the information in RTECS.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there is a description that it might irritate the skin by overexposure (HSDB (Access on August 2014)), these data were judged as insufficient for use in the classification since the details were unknown.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In an eye irritation test with rabbits, although severe irritation such as corneal opacity and swelling of the conjunctiva were observed, there was no description about irreversible lesions (RTECS, original reference (Federation Proceedings vol. 35 (1976))). From the above result, it was classified in Category 2A.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There were no in vivo data. As for in vitro, it was negative in a bacterial reverse mutation test, a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (ACGIH (7th, 2001), NTP DB (Access on September 2014), HSDB (Access on August 2014)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	Since it was classified in A4 by ACGIH (7th, 2001), it was classified as "Classification not possible." Besides, there was a classification as "Anaesthetise, volatile (Group 3)" in IARC (IARC Suppl 7 (1987)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a study with rats exposed by inhalation at 10 ppm during gestation, liver damage were observed in offspring (ACGIH (7th, 2001), IARC vol. 11 (1976)). This test was conducted with only one dose, and there was no description of maternal toxicities, therefore, it was classified in Category 2. Besides, there is a description that in a study with rats exposed by inhalation at 10 ppm in early development (from conception to 60 days old), impairments in learning ability occurred (IARC vol. 11 (1976)). On the other hand, there is a report that by inhalation exposure with mice before mating and during gestation, no effects on the course of pregnancy and fetal development were observed (ACGIH (7th, 2001)). In addition, there is a report that by inhalation exposure with rats during gestation, although reduction of fetal weight was observed, no differences were observed in litter size, fetal ossification and skeletal abnormalities compared with the control group (ACGIH (7th, 2001)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 1 (cardiovascular system, liver), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	This substance is used as an inhalation anesthetic for pharmaceutical uses. In humans, effects on the liver (hepatitis, hepatic dysfunction), effects on the central nervous system (amnesia, analgesia, anesthesia, respiratory depression), effects on the cardiovascular system (arrhythmia, vasodilatation, hypotension, bradycardia) were observed as acute effects. Liver impairment occasionally resulted from clinical anesthesia and usually occurred in patients who were previously anesthetized with halothane. In addition, vomiting, gastroenteritis, depression of consciousness, hypotension, shallow breathing, bradycardia and coma were reported by oral ingestion (ACGIH (7th, 2001), HSDB (Access on August 2014)). Therefore, the acute effects of this substance were considered to be narcotic effects and effects on the cardiovascular system and liver. There were no data in experimental animals. From the above, it was classified in Category 1 (cardiovascular system, liver), Category 3 (narcotic effects).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	In ACGIH (7th, 2001), there are reports on cases of humans who developed liver impairment by chronic exposure to this substance. It is described that in an epidemiological study in anesthetists in Czechoslovakia, an increase in the incidence of symptomatic cases such as headache and fatigue was observed among 163 anesthetists who were exposed in operating rooms where halothane concentrations were 2-4 ppm, and the onset of hepatitis was 3 times more frequent in the anesthetists than in the general population, and that in 13 workers engaged in manufacturing at a halothane manufacturing plant and exposed to halothane at an average of 660 ppm, symptoms similar to those in the anesthetists were observed, and serum AST and ALT activities were above normal levels in 1/3 of them (ACGIH (7th, 2001)). As for experimental animals, since there are descriptions that rats and rabbits were exposed by inhalation to this substance (estimated as the vapor) at 500 ppm (converted guidance value: 2.53 mg/L/6 hours) with for 7 weeks and developed centrilobular fatty infiltration of the liver (ACGIH (7th, 2001)), and that hepatic necrosis occurred in guinea pigs by repeated exposure to halothane, and hepatic necrosis may also be induced in rats by halothane anesthesia under hypoxic conditions (14%) after induction of hepatic microsomal drug-metabolizing enzymes (ACGIH (7th, 2001), PATTY (6th, 2012)), they were considered to be findings supporting liver damage in humans although those were not available for classification. From the above, based on findings in humans and experimental animals, it was classified in Category 1 (liver). Besides, although the substance was classified based only on toxicity information in experimental animals in the previous classification, it was classified including human findings this time.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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	- -	-	-	Insufficient data available.	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2006	GHS Classification Manual （10 Feb, 2006）
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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