GHS Classification Result

Chemical Name:1,1-Difluoroethane
CAS:75-37-6

Result:
ID: 21A3514
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) Category 1 Danger H220: Extremely flammable gas P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P377: Leaking gas fire: Do not extinguish, unless leak can be stopped safely.
P381: Eliminate all ignition sources if safe to do so.
P403: Store in a well-ventilated place.
The substance is classified into Division 2.1 in UNRTDG (UN1030) and the explosive range is 3.7 - 18% (in air) (SIDS (2009)).
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not classified - - - - Combustible gas
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 113.5 degC (Hommel (1996)) 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 - - - - Although there was no mortality even when rats were treated up to 1500 mg/kg and the approximate lethal dose (ALD) was estimated to be >1500 mg/kg (SIDS (2006)), classification was not possible since determination of category was impossible.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not classified - - - - Based on results from 4-hour exposure rat tests in which there was no mortality at up to 319,000 ppm, a mortality ratio of 1/6 at 383,000 ppm and 2/6 at 437,500 ppm, the approximate lethal concentration (ALC) was estimated to be 383000 ppm (SIDS (2006)). 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 Classification not possible - - - - Classification not possible due to lack of data. As relevant information, there is a report that vapour irritates the skin (HSDB (2006)), there is no additional detailed data.
3 Serious eye damage/eye irritation Classification not possible - - - - Although there is a report that vapour irritates the eye (HSDB (2003)), there is no additional detailed data. Classification is not possible due to lack of data.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - Based on a negative result in an inhalation rat bone marrow micronucleus test (in vivo somatic cell mutagenicity tests) (OECD TG474) (SIDS (2006)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of a negative Ames test (OECD TG471 (GLP)) and a weak positive in human lymphocytes chromosomal aberration test (OECD TG473) (SIDS (2006), PATTY (5th, 2001)).
6 Carcinogenicity Classification not possible - - - - Since there were no exposure related tumors in either sex in a rat 2-year inhalation test, the substance was concluded to be not carcinogenic to rats (SIDS (2006)). However, this result was obtained from a single species, therefore classification was not possible due to lack of data.
7 Reproductive toxicity Classification not possible - - - - Although there is a report of no maternal or developmental effects observed in a rat developmental test by inhalation during organogenesis period (SIDS (2006)), classification was not possible due to lack of data for sexual function and fertility of parental animals.
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 ...
From an experience where good analgesia and an impending loss of consciousness occurred in several volunteers exposed to 50% of the substance for several minutes, the substance has a narcotic effect (PATTY (5th, 2001)). Additionally, lethargy, and unresponsiveness to sound, and loss of righting reflex were observed during inhalation exposure to rats (SIDS (2006)). Based on these effects in humans and animals, the substance was classified into Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In a 2-month inhalation test with rats at 10,000 ppm/16h (90 day equivalence: 108,866 ppm/6h), no change in clinical observation or necropsy, but microscopic examination revealed a mild diffuse infiltration of small and large round cells in the lung (SIDS (2006)). Additionally, in a 2-week inhalation test with rat at 100,000 ppm/6h, no effects were observed except that the rats appeared to be anesthetized as indicated by sleeping and unresponsiveness to sound during the exposure (SIDS (2006)). However, these effects were observed at the dose level exceeding the upper limit of the guidance value range. Additionally, these tests are incomplete repeat exposure tests because of limited examination items or males only. Therefore, classification was not possible due to lack of data.
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 since values estimated by QSAR are 96h-LC50 = 733 mg/L for fish, 48h-EC50 = 720 mg/L for Crustacea, 96h-EC50 = 419 mg/L for algae (SIDS, 2007 for any) and these estimated values are cited by SIDS and therefore reliable under the circumstances where it is difficult to obtain measured value.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since it is not non-water soluble (water solubility: 3200 mg/L (PHYSPROP Database, 2009) and its acute toxicity is Not classified.


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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