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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	75-69-4
Chemical Name	Trichloro(fluoro)methane; CFC11
Substance ID	R02-B-059-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)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2002)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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."
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2002)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2002)).
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."
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. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to low-temperature-boiling liquids are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. 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] Oral LD50 could not be obtained, but because it is described in (1) that the approximate oral lethal dose for rats was 3,725 mg/kg, it was classified as "Not classified." [Evidence Data] (1) Approximate oral lethal dose for rats: 3,725 mg/kg (ACGIH (7th, 2001), Patty (6th, 2012))
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] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). Besides, because exposure concentrations were lower than 90% of the saturated vapor pressure concentration (1,056,662 ppm), a reference value in the unit of ppm was applied as a vapor with little mist. [Evidence Data] (1) LC50 for rats (30 minutes): 130,000 ppm (converted 4-hour equivalent value: 45,962 ppm) (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987)) (2) LC50 for rats (30 minutes): 856 g/m3 (152,356 ppm) (converted 4-hour equivalent value: 53,866 ppm) (EHC 113 (1990)) (3) Vapor pressure of this substance: 803 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 1,056,662 ppm)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) Application of this substance to the skin and eyes of rabbits and rats caused minor reversible irritation but no serious effects (ACGIH (7th, 2001), GESTIS (Access on May 2020), HSDB (Access on May 2020)). (2) Slight irritation was observed in a test in which this substance was applied to the rat skin, 1-2 times/day, 5 days/week, for 5-6 weeks (EHC 113 (1990), Patty (6th, 2012)). (3) No irritation was observed in a test in which this substance was applied to the rat skin, 3 times/day, 6 days/week, for 2 months (MAK (DFG) vol.1 (1991)). (4) Entry in the eye caused redness and pains, and contact with the skin caused dryness of the skin (Environmental Risk Assessment for Chemical Substances vol. 8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) Application of this substance to the skin and eyes of rabbits and rats caused minor reversible irritation but no serious effects (ACGIH (7th, 2001), GESTIS (Access on May 2020), HSDB (Access on May 2020)). (2) Slight irritation was observed in a test in which this substance was applied to the rabbit eye, 1 time/day, 5 days/week, for one month (EHC 113 (1990)).
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] There was a description of (1), but the classification was not possible due to lack of data. [Reference Data, etc.] (1) As a result of patch testing on this substance in three patients that had a prior history of allergic dermatitis to deodorant sprays, all of them showed mild to strong positive reactions to this substance. Besides, no response was shown by 15 in the control group without prior history (EHC 113 (1990)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Evidence Data] (1) As for in vivo, there were no data. (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test (MAK (DFG) vol.1 (1991), EHC 113 (1990), ACGIH (7th, 2001)), and negative in a cell transformational test and a gene mutation test using cultured mammalian cells (EHC 113 (1990), ACGIH (7th, 2001)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There was no available report in humans. From (1), (2), it was classified as "Not classified" based on ACGIH's classification result. [Evidence Data] (1) As for classification results by domestic and international organizations, ACGIH classified it in A4 (ACGIH (7th, 2001)). (2) In carcinogenicity tests in which male and female rats and mice were given 78-week gavage administration of this substance followed by observation of 33 weeks for rats and 13 weeks for mice, no tumor incidences were observed in either species, but it is described that the negative results in rats were not conclusive due to low survival. This substance was not carcinogenic to mice (NTP TR106 (1978), ACGIH (7th, 2001)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), severe effects on embryos and fetuses were observed at a dose of maternal toxicity, and it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. The data was reviewed and the classification results were changed from the previous classification. [Evidence Data] (1) In a developmental toxicity study with female rats exposed by inhalation to this substance on days 6 to 15 of gestation, an increase in embryo mortality, delayed body weight gain, and increased frequency of malformations (particularly anomalies of the heart and aortic arch) were observed at a dose (36,000 ppm) at which marked symptoms of intoxication were observed in the dams (MAK (DFG) vol.1 (1990)). The Environmental Risk Assessment for Chemical Substances, Vol. 8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010) described that the symptoms of intoxication in the dams observed were blepharoptosis, lacrimation, salivation, etc. (2) In a developmental toxicity study with female rabbits exposed by inhalation to this substance on days 6 to 18 of gestation, an increase in embryonic death, lower fetal weight, and extra thoracolumbar ribs in 81.6% of fetuses were observed at a dose (36,000 ppm) at which maternal toxicity (no details provided) was observed (MAK (DFG) vol.1 (1990)).
8	Specific target organ toxicity - Single exposure	Category 1 (heart), Category 3 (narcotic effects, respiratory tract irritation)	Danger Warning	H370 H336 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1) to (5), it was classified in Category 1 (heart) and Category 3 (narcotic effects, respiratory tract irritation). [Evidence Data] (1) In a case of fatal poisoning due to inhalation of this substance, the cause of death was considered to be arrhythmia and cardiac arrest caused by sensitization of the cardiac muscle to catecholamine, or suffocation due to hypoxemia caused by saturation of this substance in an enclosed environment (Environmental Risk Assessment for Chemical Substances, Vol. 8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (2) This substance had weak narcotic effects, irritation to the respiratory organs, and slight effects on the heart (OEL Documentations (Japan Society for Occupational Health (JSOH), 1987)). (3) As a result of a 30-minute inhalation exposure test with humans to this substance (50,000 ppm), irritation in the eye was observed, and neurological symptoms of dizziness appeared (OEL Documentations (Japan Society for Occupational Health (JSOH), 1987)). (4) Workers who spilled a large volume of this substance and were exposed to high concentrations developed signs of narcosis. One of the workers became unconscious, and another experienced tachycardia (ACGIH (7th, 2001), HSDB (Access on May 2020), GESTIS (Access on May 2020)). (5) In human subjects inhaling air containing 10% of this substance, bradycardia was the usual response, and it originated from irritation caused by this substance to the upper respiratory tract (HSDB (Access on May 2020)). [Reference Data, etc.] (6) Chlorofluorocarbon compounds were known to sensitize the heart to 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), no apparent effects were reported in humans exposed to this substance by inhalation, and based on (2) to (4), no toxic effects were observed in test animals exposed by inhalation or oral route, and therefore, it was classified as "Not classified." In a 1-month test with rats in (5), effects on the blood system, liver, and kidney were observed within the range for Category 2, however, since these effects were not observed in a 90-day test with rats in (3) and a 90-day test with dogs in (4), it was not adopted as rationale for the classification. [Evidence Data] (1) After exposure to this substance of 1,000 ppm for 4 weeks, 8 hours per day, 46 male and female test persons did not exhibit any changes in the general condition or the heart and lung functions, apart from slight decrease in the perceptive faculty (GESTIS (Access on May 2020)). (2) In a 90-day (6 hours/day) test with dogs and rats exposed by inhalation to concentrations (dogs: 5,000 ppm; rats: 10,000 ppm) far exceeding the guidance values, no effect was observed in blood composition, clinical chemical parameters, or tissue examinations (Environmental Risk Assessment for Chemical Substances, Vol. 8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (3) In a 90-day test by oral administration to rats, a slight increase in the fluoride level in the urine was observed at 450 mg/kg/day (exceeding Category 2), but it was an inconsistent change, and the relationship with the administration was unclear. The other urine and blood parameters remained unchanged, and no toxic symptoms were observed (MAK (DFG) vol.1 (1990)). (4) In a 90-day test by oral administration of 40 to 350 mg/kg/day (within the range for Category 2 to exceeding Category 2) to dogs, neither toxic effects were observed, nor were biochemical changes detectable (MAK (DFG) vol.1 (1990)). [Reference Data, etc.] (5) In a 1-month test by oral administration to rats, at 54.5 mg/kg/day (converted guidance value: 18.2 mg/kg/day, within the range for Category 2), congestion, slight hemosiderosis, and increased lymph follicles in the spleen were observed; and at 128 mg/kg/day (converted guidance value: 43 mg/kg/day, within the range for Category 2), deaths (8/15), focal cellular infiltration, slight congestion around the central vein in the liver, focal cellular infiltration of the interstitium, slight dilatation of the renal tubules, and scattered lymph follicles in the kidney were observed (Environmental Risk Assessment for Chemical Substances, Vol. 8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.
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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