NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-56-9
Chemical Name	Propylene oxide (1,2-Epoxypropane)
Substance ID	m-nite-75-56-9_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 1	Danger	H224	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with self-reactive properties (strained ring (epoxides)) present in the molecule. However, because it is classified in Class 3, PG I (UN1280) in UNRTDG and does not correspond to hazards of the highest precedence, self-reactive substances and mixtures, it was classified as Type G.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Not classified	- -	-	-	Since it is reported as "noncorrosive to metals" (HSDB (2010)), the substance is classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Category 3	- -	H402	P273 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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