GHS Classification Result (Revision of the past classification result)

Chemical Name:1,2-Epoxypropane; Propylene oxide
CAS:75-56-9

Result:
ID: 22B4527
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Category 1 Danger H224: Extremely flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Since its flash point -37 degC (closed-cup) (ICSC (1995)) is < 23 degC and initial boiling point 34 degC (ICSC (1995)) is <= 35 degC, the substance corresponds to Category 1. As relevant notes, the substance is classified into Class 3, PG I (UN1280) in UNRTDG.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not classified - - - - The substance does not fall under Self-reactive substances and mixtures since it is classified into Class 3, PG I in UNRTDG (UN1280) though it contains chemical groups (Strained ring (epoxides)) associated with self-reactive properties in the molecule.
9 Pyrophoric liquids Not classified - - - - Since its autoignition temperature is 449 degC (ICSC (1995)), it is considered that the substance does not ignite at room temperature.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Not classified - - - - Since it is reported as "noncorrosive to metals" (HSDB (2010)), the substance is classified as "Not classified".

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Three LD50 values for rats of 1140, 520 mg/kg (EHC 56 (1985)) and 930 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 3 (2004)) were reported and all of them correspond to Category 4. Therefore the substance was classified into Category 4.
1 Acute toxicity (Dermal) Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
Two LD50 values for rabbits of 950 mg/kg (EU-RAR 23 (2002)) and 1245 mg/kg (ACGIH (2001)) were reported. Selecting the greater hazard category, the substance was classified into Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
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.
Based on the rat LC50 value (4-hour exposure) of 4000 ppm (EHC 56 (1985)), the substance was classified as Category 4. The LC50 value (4000 ppm) was lower than 90% of saturated vapor pressure concentration (707894.7 ppm), the criterion values for gas were adopted. The LC50 value (399 ppm) in the previous classification was corrected because of the error of unit conversion.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
In the rabbit test, application of the undiluted substance or 10% and 20% aqueous solutions for periods of 1 - 60 minutes produced erythema and edema by exposure for 6 minutes and more. The more severe conditions of exposures resulted in scar formation. Thus, this study suggested that skin irritation may occur by exposure to the substance even for a short period (EU RAR 23 (2002)). On the other hand, in other rabbit study, although the possibility of evaporation of the test substance from the surface of the skin during the exposure period could not be denied, semi-occlusive application for 4 hours did not cause neither erythema nor edema after 1, 2 and 8 days of treatment (EU RAR 23 (2002)). Based on the description that in over-all judgment, the substance may cause local irritation by contact with skin (EU RAR 23 (2002)), the substance was classified as Category 2. As relevant information, there were no data suggesting corrosive effects of the substance (EU RAR 23 (2002)).
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
The persons who were exposed accidentally to the eyes caused burns of cornea and conjunctiva (EU RAR 23 (2002)). Corneal burns were reported in humans, and it was reported that the substance caused severe irritation (ACGIH (2001)). In the rabbit test, single instillation of 5 microL of the undiluted test substance to the center of the cornea caused a severe burn with necrosis (EHC 56 (1985)). Based on the information, the substance was classified as Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
The substance was classified as Category 1 based on the classification as "SEN (skin sensitizer)" in the assessment by the ACGIH (ACGIH (2001)). As relevant information, two cases of positive reaction of patch test were reported in the patients who developed the symptoms of skin such as allergic contact dermatitis to the substance (Initial Risk Assessment Report (NITE, CERI, NEDO) (2007)).
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
The results of the dominant lethal tests using mice or rats inhaled or orally administered (in vivo inheritable mutagenicity test in germ cells) were negative (Initial Risk Assessment Report (NITE, CERI, NEDO) (2007)). Positive results were indicated in the chromosome aberration test and micronucleus test using bone marrow cells of mice intraperitoneally administered (in vivo mutagenicity test in somatic cells) (Initial Risk Assessment Report (NITE, CERI, NEDO) Ver. 1.0, 47 (2007)). No positive results were reported in vivo genotoxicity test in germ cell. Therefore, the substance was classified as Category 2. As relevant information, as for in vitro studies, negative or positive results in the Ames test and positive results in the chromosome aberration tests using rat liver cells and human lymphocytes were reported (Initial Risk Assessment Report (NITE, CERI, NEDO) (2007)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
The substance was classified as Category 2 based on the criteria of "R" in the carcinogenicity assessment of the NTP (NTP (2005)), "Group 2B" in the IARC (IARC (1994)), "A3" in the ACGIH (ACGIH (2001)) and "B2" in the EPA (EPA (1994)). As relevant information, in the 103-week inhalation test in mice, a significant increase in the incidences of hemangiomas of the nasal cavity in both sexes at 400 ppm exposure group, and a significant increase in the incidences of angiosarcoma of the nasal cavity in males at 400 ppm exposure group were reported. In the 103-week inhalation test in rats, significant increase in the incidences of squamous cell carcinomas of the nasal cavity in both sexes at 400 ppm exposure group, and significant increase in the incidences of papillary adenomas of the nasal cavity in females at 400 ppm exposure group, were reported. The incidences of squamous cell carcinomas of the nasal cavity epithelium were statistically significant in both sexes of 400 ppm exposure but were not significant in the 200 ppm exposure compared to the controls (Initial Risk Assessment Report (NITE, CERI, NEDO) Ver. 1.0, 47 (2007) , NTP test).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In the study that rats were exposed to vapor at 500 ppm, for 3 weeks prior to mating, and thereafter through days 1 - 16 gestation, maternal body weight gain was significantly reduced and the mean number of corpora lutea was reduced compared to those of the control group, and as a consequence of this the numbers of implantations and surviving live fetuses were correspondingly decreased, and the increase in the incidence of minor anomalies e.g. wavy ribs (EU-RAR 23 (2002)). In the study that rabbits were exposed to vapor at 500 ppm during the organogenetic period, slight decreases in food consumption and body weight gain of the dams and increase in the number of resorptions were observed (DFGMAK-Doc. 5 (1993)). At the dose that decrease in the parental body weight gain was observed, reproductive effects such as the decrease in the numbers of implantations and surviving live fetuses in rats, and increase in the number of resorption, etc. in rabbits were observed. Therefore, the substance was classified as Category 2. In addition, it was reported that 50% of orally administered males appeared "infertile". However, it was also mentioned that the dose levels noted these findings were close to the oral LD50 range that significant general toxicity was observed, and therefore no definite conclusion could be reached from these results (EU-RAR 23 (2002)).
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation, Narcotic effects) Warning H335: May cause respiratory irritation (respiratory tract irritation, narcotic effects)
H336: May cause drowsiness or dizziness (respiratory tract irritation, 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 the report stating that dyspnea and bleeding from the nose were noted in the inhalation study in rats (Initial Risk Assessment Report (NITE, CERI, NEDO) (2007)), the substance was classified as Category 3 (respiratory tract irritation). It was also reported that no deaths occurred in the inhalation studies in rats and guinea pigs exposed for 0.25 - 7 hours at the concentrations of 2000 - 16000 ppm, and the clinical signs observed included lethargy and motor incoordination (Initial Risk Assessment Report (NITE, CERI, NEDO) (2007)). Thus, the substance was classified as Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - The classification was not possible due to lack of sufficient data. As relevant information, no adverse effects were observed up to the concentration of 0.71 mg/L (within the range of Category 2 of the guidance values) in the 24-week inhalation study in rats (EU-RAR 23 (2002)). Moreover, it was described that abnormalities in hematological and blood biochemical examination were found at 0.52 mg/kg (within the range of Category 2 of the guidance values) in the 26-week administration study via drinking water in rats (EHC 56 (1985)). However, descriptions for the degree of the changes and pathological findings were not provided.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 3 from its 96h-LC50 = 52 mg/L for fish (Oncorhynchus mykiss) (EU-RAR, 2002; Initial Risk Assessment Report (NITE, CERI, NEDO), 2007).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since it is rapidly degradable (BOD degradation rate: 96% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1988)) and its bioaccumulation potential is estimated to be low (Log Kow = 0.03 (PHYSPROP Database, 2009)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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