NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	96-09-3
Chemical Name	Phenyloxirane; Styrene Oxide
Substance ID	R02-B-047-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 FY2014 FY2018
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	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 based on a flash point of 76 deg C (closed cup) (ICSC (2006)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties, an epoxide, present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 498 deg C (HSDB (Access on June 2020)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
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 oxygen (but not fluorine or chlorine) which is 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	- -	-	-	No data 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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1) - (4). [Evidence Data] (1) LD50 for rats: 2,000 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), GESTIS (Access on May 2020)) (2) LD50 for rats: 2,000-4,290 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare) (Access on May 2020)) (3) LD50 for rats: 3,000 mg/kg (ACGIH (7th, 2020)) (4) LD50 for rats: 3,000-4,290 mg/kg (AICIS (formerly, NICNAS) IMAP (2015))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1) - (4). [Evidence Data] (1) LD50 for rats: 930 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare) (Access on May 2020), ACGIH (7th, 2020)) (2) LD50 for rabbits: 930 mg/kg (ACGIH (7th, 2020)) (3) LD50 for rabbits: 930-1,184 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare) (Access on May 2020), AICIS (formerly, NICNAS) IMAP (2015)) (4) LD50 for rabbits: 935 mg/kg (GESTIS (Access on May 2020))
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)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] It was classified in Category 4 from (1). Besides, the classification result was changed from the previous classification by the use of a new information source. Because an exposure concentration was higher than the saturated vapor pressure concentration (1.94 mg/L), a reference value in the unit of mg/L was applied as mist. [Evidence Data] (1) LC50 for rats (4 hours): 500 ppm (2.46 mg/L) (ACGIH (7th, 2020)) (2) Vapor pressure of this substance: 0.3 mmHg (20 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 1.94 mg/L)
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It was classified in Category 2 from (1) - (4). [Evidence Data] (1) An undiluted or 1% solution caused moderate irritation (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). (2) It was reported to be irritating in a skin irritation test with rabbits (ACGIH (7th, 2020)). (3) Exposure to this substance caused skin and eye irritation in humans (AICIS (formerly, NICNAS) IMAP (2015)). (4) Moderate irritation was observed for this substance in humans and animals (GESTIS (Access on May 2020)). [Reference Data, etc.] (5) Short-term exposure irritated the eye and skin, and erythema, pains, and severe burns in the eye and erythema and burns in the skin were seen (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2A from (1) - (4). [Evidence Data] (1) Short-term exposure irritated the eye and skin, and erythema, pains, and severe burns in the eye and erythema and burns in the skin were seen (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). (2) In an eye irritation test by application of this substance to the rabbit eye, there was corneal irritation which persisted for more than 24 hours, and the effects were reversed within 21 days after the treatment (AICIS (formerly, NICNAS) IMAP (2015), REACH registration dossier (Access on July 2020)). (3) Exposure to this substance caused skin and eye irritation in humans (AICIS (formerly, NICNAS) IMAP (2015)). (4)Exposure to this substance caused severe painful irritation but not corrosion (GESTIS (Access on May 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) An undiluted or 1% solution caused moderate irritation and sensitization, exposure to vapor was likely to cause hypersensitivity than contact with liquid, and long-term or repeated contact might cause skin sensitization (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). (2) In a skin sensitization test in guinea pigs (maximization test), it was sensitizing, and the positive rate was reported to be 60% (ACGIH (7th, 2020)). (3) This substance caused skin sensitization in humans upon contact with its vapor or liquid (AICIS (formerly, NICNAS) IMAP (2015)). (4) Intradermal administration of this substance to guinea pigs triggered sensitization (GESTIS (Access on May 2020)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test with mice and micronucleus tests in bone marrow cells from mice/hamsters. And it was reported to be positive and negative in chromosomal aberration tests in bone marrow cells from mice/hamsters and DNA damage tests using somatic cells from rats/mice (IARC 121 (2019), ACGIH (7th, 2020)). (2) As for in vitro, there were multiple reports that it was positive in bacterial reverse mutation tests, gene mutation tests with cultured mammalian cells, micronucleus tests using human peripheral blood and mammalian somatic cells, and chromosomal aberration tests and sister chromatid exchange tests using human peripheral blood (same as the above).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There was no sufficient report on the carcinogenicity of exposure to this substance in humans. It was classified in Category 1B based on IARC's latest assessment in (1) and its rationale, information in (2) - (4). [Evidence Data] (1) As for classification results by domestic and international organizations, It was classified in Group 2A by IARC (IARC 121 (2019)), Group 2A by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH)) (proposed in 1992, reviewed in 2018)), A3 by ACGIH (ACGIH (7th, 2020)), R (Reasonably anticipated to be human carcinogens) by NTP (NTP RoC (14th, 2016)), and 1B in EU CLP (EU CLP classification (Access on May 2020)). (2) In a carcinogenicity test by 2-year gavage administration of this substance to male and female mice, significant increases in incidences of squamous cell papilloma and carcinoma of the forestomach in males and females, and hepatocellular adenoma or carcinoma (combined) in males were observed (IARC 121 (2019)). (3) In two carcinogenicity tests by 2-year gavage administration of this substance to male and female rats, significant increases in incidences of squamous cell papilloma and carcinoma of the forestomach in males and females were observed in both the tests, and a significant increase in the incidence of benign mammary tumors in males was seen in one test (IARC 121 (2019)). (4) This substance is an electrophile. There is strong evidence in humans that it forms DNA adducts and is genotoxic. This mechanism can also operate in humans (IARC 121 (2019)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), although deaths of dams were observed, the number of death cases was unknown. However, serious effects in fetuses (an increase in preimplantation embryo loss) were observed. Therefore, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a test in which female rats were exposed to this substance by vapor inhalation during a three-week pregestational period, from a three-week pregestational period through days 1 to 19 of gestation, or on gestational days 1 to 19, all dams died on the day of exposure at 300 ppm (1,470 mg/m3). At 100 ppm (490 mg/m3) at which maternal toxicity (death (the number of death cases not stated), reduced body weight gain) was observed, an increase in preimplantation embryo loss, decreases in fetal weight and length, and an increased incidence of retarded ossification of the sternebrae and occipital bones were observed (IARC 60 (1994), Environmental Risk Assessment for Chemical Substances Vol. 4: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). [Reference Data, etc.] (2) In a developmental toxicity study with female rabbits exposed by inhalation on days 1 to 24 of gestation, an increase in post-implantation embryo loss was observed at a dose at which maternal toxicity (death (4/24 cases)) was observed (IARC 60 (1994), Environmental Risk Assessment for Chemical Substances Vol. 4: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). The IARC 60 (1994) reported that maternal toxicity was observed only at the highest dose at which 19 out of 24 rabbits died.
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (respiratory organs) and Category 3 (narcotic effects). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) Severe damages may occur due to direct contact with the respiratory tract (ACGIH (7th, 2020)). (2) Massive exposure of humans may cause an irritation of the respiratory tract, toxic lung edema, nausea, and central nervous depression (GESTIS (Access on August 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified" in the oral route. However, no data was available in the other administration routes, and it was classified as "Classification not possible." Human data, which was the rationale for the previous classification, could not be confirmed. The classification was based on the data from animal experiments, and the classification results were changed from the previous classification. [Evidence Data] (1) In a 24-week repeated dose toxicity study with rats dosed by gavage (3 days/week), at the lowest dose of 180 mg/kg/day (converted guidance value: 144 mg/kg/day, exceeding Category 2), liver cell hyperplasia and renal tubular degeneration were observed; and at or above 1,500 mg/kg/day (converted guidance value: 1,200 mg/kg/day, exceeding Category 2), an increase in mortality was observed, and in the animals that died, basal cell hyperplasia and hyperkeratosis of the forestomach, lesions in the liver, and renal tubular epithelial degeneration or necrosis were observed (AICIS (previous NICNAS) IMAP (2015)). (2) In a 20-week repeated dose toxicity study with mice dosed by gavage (3 days/week), basal cell hyperplasia and hyperkeratosis of the forestomach, and hyperplasia of the liver were observed at or above 600 mg/kg/day (converted guidance value: 480 mg/kg/day, exceeding Category 2) (AICIS (previous NICNAS) IMAP (2015)). (3) In a 52-week repeated dose toxicity study with rats dosed by gavage and a 20-week repeated dose toxicity study with mice dosed by gavage (3 days/week), lesions in the forestomach were observed at doses within the range for Category 2 or exceeding Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 4: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), AICIS (previous NICNAS) IMAP (2015)). (4) In a 104-week repeated dose toxicity study with rats and mice dosed by gavage, reduced body weight gain and a decrease in survival rate were observed at doses exceeding Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 4: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, kinematic viscosity was calculated as 1.9 mm2/sec at 20 deg C in (1), and kinematic viscosity at 40 deg C was 14 mm2/s or less, but other information could not be obtained. [Reference Data, etc.] (1) Kinematic viscosity was 1.9 mm2/s at 20 deg C (calculated from viscosity at 20 deg C: 1.99 mPa*s (HSDB (Access on July 2020)) and density of 1.05 g/cm3 (HSDB (Access on July 2020))).

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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 1.9 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified in Category 3 because it was rapidly degradable (a 2-week degradation rate by BOD: 81% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1988)) and due to 21-day NOEC = 0.14 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it was rapidly degradable (a 2-week degradation rate by BOD: 81% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1988)) and due to a low bioaccumulation estimate (log Kow = 1.61 (SRC PhysProp Database)), despite 96-hour LC50 = 8.8 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)). By drawing a comparison between the above results, it was classified in Category 3.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not 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.

To GHS Information