NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	556-52-5
Chemical Name	2,3-Epoxy-1-propanol
Substance ID	m-nite-556-52-5_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	Classified into Category 4 (GHS criteria: flash point >60 degC and <=93 degC) from flash point 72 degC (closed-cup) (ICSC (J) 2005)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Classification is not possible since no data are available though it is known that the substance contains stained ring (epoxides) and causes extremely violent polymerization reaction on contact with metal salts (Hommel (1996)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified	- -	-	-	Auto-ignition point is 415 degC (ICSC (J) (2005), Ullmanns (E) (6th, 2003), Hommel (1996)) exceeding 70 degC.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. High quality steel, aluminum, glass and enamel have a durability as containers (Hommel (1996)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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	Based on LD50 values of 850 mg/kg, 760 mg/kg (male), 640 mg/kg (female) (PATTY (5th, 2001) and 550 mg/kg (DFGOT vol. 20 (2003)) for rats, the substance was classified into Category 4.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on a LD50 value of 1980 mg/kg for rabbits (ACGIH (2001)), the substance was classified into Category 4.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on LC50 values of 580 ppm/8h (820 ppm/4h) (ACGIH (2001)) and 500 ppm/8h (707 ppm/4h) (DFGOT vol. 20 (2003)) for rats, the substance was classified into Category 3. Since the LC50 value was lower than 90% of saturated vapour pressure concentration (1188 ppm), the classification criteria for gas (ppm) was adopted.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on results of "moderately irritating" (ACGIH (2001), PATTY (5th, 2001)) and irritation score of 4.5 (maximal value: 8.0) (PATTY (5th, 2001)) in a rabbit test, the substance was classified into Category 2. In EU classification, the substance is classified into Xi; R36/37/38 (EU-Annex I (access on May 2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Based on a report of severe but reversible corneal disorder following application to rabbit eyes (ACGIH (2001), PATTY (5th, 2001)), the substance was classified into Category 2A. In EU classification, the substance is classified into Xi; R36/37/38 (EU-Annex I (access on May 2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	Based on positive results in a bone marrow micronucleus test by intraperitoneal administration to mice and a chromosomal aberration test by intraperitoneal administration to rats and mice (in vivo somatic cell mutagenicity tests) (DFGOT vol. 20 (2003)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of a positive Ames test, a positive mouse lymphoma test, and positive CHO cell and human lymphocyte chromosomal aberration tests (DFGOT vol. 20 (2003), ACGIH (2001)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on the classifications of "2A" in IARC (IARC vol.77 (2000)), "2A" in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)) and "Category 2" in EU classification (EU-Annex I (access on May 2009)), the substance was classified into Category 1B. In a 103-week oral test in rats, the incidences of gliomas of the brain and forestomach tumours were increased in both sexes. The incidence of mesotheliomas of the tunica vaginalis/peritoneum, and tumours in the intestine, Skin thyroid, and Zymbal gland were increased in male rats, and the incidences of tumours of the clitoral gland, mammary gland, oral mucosa and leukaemia were increased in female rats. In a 103-week oral test in mice, the incidence of Harderian gland tumours was increased in both sexes, and increased incidences of tumours of the forestomach, lung, liver and skin in males, the mammary gland and subcutis in females were observed (IARC vol. 77 (2000)). In a 104-week inhalation test in rats, the incidences of nasal cavity tumor and peritoneal tumor were significantly increased in males, and the incidences of nasal cavity tumor and uterine tumor were increased in female. The results are considered to be clear evidence of carcinogenic activity of 2,3-Epoxy-1-propanol for male and female F344/DuCrlj (Fischer) rats. In a mouse test, the incidences of nasal cavity tumor, subcutaneous tissue tumor and peripheral nervous system tumor were increased in males, and the incidences of nasal cavity tumor, uterine tumor and mammary gland tumor were increased in females. The results are considered to be clear evidence of carcinogenic activity of 2,3-Epoxy-1-propanol for male and female Crj/BDF1 mice (Results from Carcinogenicity tests (Ministry of Health, Labour and Welfare) (2002)). The Ministry of Health, Labour and Welfare has made a public announcement on guidelines in order to prevent the impairment of worker's health based on Industrial Safety and Health Act Article 28-3 (2006).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Since in a mouse test (route not stated), resorptions and fetal deaths and anomalies were increased at a maximum tolerated dose for parent animals (IARC 77 (2000)), the substance was classified into Category 2. Injections of the substance into the amniotic cavity of pregnant rats on day 13 of gestation resulted in embryonal deaths and to a significant increase in the incidence of malformations of the fore and hind limbs (DFGOT vol. 20 (2003)). This result was not used as the basis for the determination of classification since the exposure level is considered to be much higher than that expected by conventional exposure routes.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In acute oral toxicity tests in rats and mice (LD50 values: 850 mg/kg for rats, 450 mg/kg for mice), symptoms of intoxication were initial depression of the CNS followed by hypersensitivity to sound with muscular tremors and facial muscular fibrillation. Some rats showed terminal convulsions (PATTY (5th, 2001)). In an acute dermal toxicity test in rabbits (LD50 value: 1980 mg/kg) and acute inhalation tests in rats and mice (vapour, LC50 values (4-hour equivalence): 1.36 - 1.78 mg/L), effects on the central nervous system were reported (DFGOT vol. 20 (2003), PATTY (5th, 2001)). Additionally, by inhalation, lung irritation, pneumonia and emphysema were also detected (PATTY (5th, 2001), ACGIH (2001)). Since these adverse effects are estimated to occur near or below the LD50 value (LC50 value) and the inhalation LC50 value is within the guidance value range for Category 1, the substance was classified into Category 1 (central nervous system, respiratory system).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 2 (central nervous system, spleen, testis)	Warning	H373	P260 P314 P501	In 13-week oral tests with rats and mice (NTP TR374 (1990)) and a 16-day oral test with mice (NTP TR374 (1990)), demyelination in the medulla of the brain (both species) and necrosis of the cerebellum (rat only) were observed. One of these findings occurred at a dose level of 300 mg/kg/day (90-day equivalence: 53.3 mg/kg/day) in the 16-day oral test with mice. In the 13-week oral tests with rats and mice (NTP TR374 (1990)), a 40-week oral test in mice (NTP GMM-13 (2007)) and a 16-day oral test with rats (NTP TR374 (1990)), degeneration of the epididymal stroma, atrophy of the testis, granulomatous inflammation of the epididymis occurred and sperm count and sperm motility were reduced. These effects were observed at dose levels of 100 mg/kg/day and higher in the 13-week test with rats, and 19 mg/kg/day and higher concentrations in the 13-week test with mice. In a 2-year oral test with rats (37.5 - 75 mg/kg/day), fibrillation in the spleen was observed in both sexes (NTP TR374 (1990)). As above, since the adverse effects were observed at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (central nervous system, testis, spleen). As target organs, the liver was excluded and the testis was included due to priority modification of the documents and data addition.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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-EC50 = 53310 microg/L for algae (Pseudokirchneriella subcapitata) (AQUIRE, 2010).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified into Not classified since it is rapidly degradable (BOD degradation rate: 85% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)) and low bioaccumulative potential is estimated (log Kow = -0.95 (PHYSPROP Database, 2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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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