GHS Classification Result

Chemical Name:1,1,1,2-tetrafluoroethane
CAS:811-97-2

Result:
ID: 21A3509
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - Gas (GHS definition)
2 Flammable gases (including chemically unstable gases) Not classified - - - - Not combustible gas (Merck (14th, 2006))
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not classified - - - - Classified into Not classified since the substance is classified into Division 2.2 in UNRTDG (UN3159) without the description on Subsidiary risk and ERG is 126, not 122 (Gases - Oxidizing (Including Refrigerated Liquids)).
5 Gases under pressure Low pressure liquefied gas Warning H280: Contains gas under pressure; may explode if heated P410+P403: Protect from sunlight. Store in a well-ventilated place. Critical temperature is 101.05 degC (Merck (14th, 2006)) exceeding 65 degC.
6 Flammable liquids Not applicable - - - - Gas (GHS definition)
7 Flammable solids Not applicable - - - - Gas (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - Gas (GHS definition)
9 Pyrophoric liquids Not applicable - - - - Gas (GHS definition)
10 Pyrophoric solids Not applicable - - - - Gas (GHS definition)
11 Self-heating substances and mixtures Not applicable - - - - Gas (GHS definition)
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - Gas (GHS definition)
13 Oxidizing liquids Not applicable - - - - Gas (GHS definition)
14 Oxidizing solids Not applicable - - - - Gas (GHS definition)
15 Organic peroxides Not applicable - - - - Gas (GHS definition)
16 Corrosive to metals Classification not possible - - - - Test methods applicable to gaseous substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Classification not possible - - - - No data available.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not classified - - - - Based on 4 hour exposure LC50 values of >500,000 ppm (ECETOC (2000)), 567,000 ppm (IRIS (2003)) and 289,000 ppmV (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 7 (2009)) for rats, the substance was classified as "Not classified".
1 Acute toxicity (Inhalation: Vapours) Not applicable - - - - Gas (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Not applicable - - - - Gas (GHS definition)
2 Skin corrosion/irritation Not classified - - - - Based on results of only slight signs of irritation (PATTY (5th, 2001)) or not irritating (ECETOC JACC No. 50 (2006)) in rabbit tests, the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Not classified - - - - From results of only slight signs of irritation (PATTY (5th, 2001)) and not irritating (ECETOC JACC No. 50 (2006)) in rabbit tests, the substance was classified as "Not classified".
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on a result that sensitization was not observed in a guinea pig maximization test (ECETOC JACC No.50 (2006), DFGOT vol. 13 (1999)), the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - Based on a negative result in an inhalation mouse dominant lethal test (in vivo heritable germ cell mutagenicity tests) and negative results in an inhalation mouse bone marrow micronucleus test and a chromosomal aberration test (in vivo somatic cell mutagenicity tests) (ECETOC JACC 50 (2006)), the substance was classified as "Not classified". As relevant information, from in vitro tests, there are reports of a negative Ames test and a negative chromosomal aberration test (ECETOC JACC 50 (2006)).
6 Carcinogenicity Not classified - - - - In a chronic/carcinogenicity test in rats with inhalation for 104 weeks, treatment related effects were limited to the testis. Increases in testis weight and incidence of testicular Leydig cell hyperplasia and adenomas were observed (ECETOC JACC 50 (2006)). However, this benign tumor was observed in the control animals and is common in aged rats, and there were no other treatment related neoplastic lesions or non-neoplastic lesions. In a mouse test with inhalation for 106 week, there were no treatment related tumors (ECETOC JACC 50 (2006)). There are no tests other than inhalation exposure as the substance is a gas and its major exposure route is by inhalation. Based on no treatment related tumor finding in either rat or mouse test, the substance was classified as "Not classified".
7 Reproductive toxicity Not classified - - - - Descriptions of no effect on reproductive performance or development of the offspring were reported in a rat reproductive test by inhalation (ECETOC JACC 50 (2006)) and no adverse effects were reported on fetal development including teratogenicity in both rat and rabbit developmental toxicity tests by inhalation during organogenesis period (ECETOC JACC 50 (2006)). Based on these findings, the substance was classified as "Not classified". Additionally, decreased maternal weight gain and fetal delayed ossification were observed in a rat inhalation test (ECETOC JACC 50 (2006)).
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects) Warning H336: May cause drowsiness or dizziness (narcotic effects) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on reports that narcotic effect was observed in mice, rats and dogs by inhalation (ECETOC JACC 50 (2006)), the substance was classified into Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Not classified - - - - NOEL in a chronic/carcinogenicity test in rats with inhalation for 52 weeks (6 hr/day) was 1000 ppm (ECETOC JACC 52 (2006)). NOAEL in rat 90-day inhalation test (6 hr/day) was 5000 ppm (IRIS (2003). Results demonstrate no effects at the dose exceeding the upper limit (250 ppm) of the guidance value range for Category 2. From many reports of inhalation tests such as rat 28-day, rat 13-week, mouse 90-day, dog 3-month and dog 1-year, there were no reports or reports of effects at the dose within the guidance value range (<=250 ppm) (IRIS (2003), DFGOT vol.13 (1999), ECETOC JACC 50 (2006)). There are only inhalation exposure tests as the substance is a gas and its major exposure route is inhalation. Therefore the substance was classified as "Not classified". As relevant information, no exposure related adverse effects were reported in healthy volunteer tests (ECETOC JACC 50 (2006), Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 7 (2009)).
10 Aspiration hazard Not applicable - - - - Gas (GHS definition)

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Not classified - - - - Classified into Not classified from its 96h-LC50 = 450 mg/L for fish (Rainbow trout), 48h-EC50 = 980 mg/L for Crustacea (Daphnia magna) (CICAD 11, 1998).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (estimated value of water solubility = 2040 mg/L (PHYSPROP Database, 2009)).


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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