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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	51-79-6
Chemical Name	Urethane
Substance ID	23B5504
Classification year (FY)	FY2011
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
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	There is information that it is combustible (ICSC (J) (2010)), but there are no data in the prescribed test.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is a compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

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	It was classified in Category 4 based on an LD50 value of 1,809 mg/kg for rats (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	It was classified in Category 4 based on an LD50 value of 1,800 mg/kg for rats (Initial Risk Assessment Report, Ministry of Health, Labour and Welfare (Access on August 2011), corresponding to List 1).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Data are lacking. Besides, it is described that it causes erythema and pain when in the eyes (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), but the details are unknown.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	There are many reports of micronucleus tests with bone marrow or peripheral blood after oral or inhalation administration to mice (in vivo somatic cell mutagenicity tests), most of which gave positive results (JECFA 1125 (2006)). Therefore, it was classified in Category 2. Besides, as for other in vivo tests, a dominant lethal test with mice and a specific locus test with mice (in vivo heritable germ cell mutagenicity tests) were reported to be negative (JECFA 1125 (2006)), and a chromosomal aberration test, a sister chromatid exchange test, and an unscheduled DNA synthesis test with somatic cells were reported to be positive (JECFA 1125 (2006)). As for in vitro tests, it is reported that it was negative or positive in Ames tests, positive in a chromosomal aberration test with human peripheral lymphocytes, and negative in a chromosomal aberration test with CHO cells (Initial Risk Assessment Report, Ministry of Health, Labour and Welfare (Access on August 2011), JECFA 1125 (2006), NTP DB Study ID 588195 (1987)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 1B because IARC classified it in Group 2A for carcinogenicity (IARC 96 (2010)). Besides, it was classified in Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2004)), and Carc. Cat.2; R45 by the EU (EC-JRC (ESIS) (Access on Aug. 2011)). Furthermore, it is reported that in a lifetime drinking water administration test with mice, the tumors showing clear dose-dependence were tumors of the lung (mainly adenomas and adenocarcinomas) and hemangioendotheliomas (mainly in the liver) in both sexes and mammary gland carcinomas in females (JECFA 1125 (2006)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a test by inhalation exposure of mice on a gestational day 9, significant increases in external anomalies (cleft palate, polydactyly) and abnormal spines were reported in fetuses after 24-hour or 36-hour exposure (Initial Risk Assessment Report, Ministry of Health, Labour and Welfare (Access on August 2011)), although there are no descriptions of general toxicity in maternal animals. Furthermore, after oral administration of 1,000 mg/kg to pregnant rats, decreased food consumption and reduced weight gain were observed as general toxicity in maternal animals, on the other hand, as reproductive effects, in addition to decreased body weight and increased resorptions in fetuses, malformations of absent tails and exencephaly brain were seen after administration on gestational days 6-12, and increases in skeletal abnormalities in the vertebrae and sternebrae were found after administration on gestational days 0-5, 6-12, or 13-19 (JECFA 1125 (2006)). Based on the above reports, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	In humans, it is reported that inhalation causes loss of consciousness, and ingestion causes nausea, vomiting, and loss of consciousness (Initial Risk Assessment Report, Ministry of Health, Labour and Welfare (Access on August 2011)). Furthermore, it is described that a dose of 1,000 mg/kg bw causes anesthesia in an oral administration test with rodents (JECFA WHO 930 (2006)). Therefore, it was classified in Category 3 (narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Category 2 (hematopoietic system)	Warning	H373	P260 P314 P501	In 13-week repeated oral administration tests (drinking water) with rats and mice, in rats, decreases in leukocytes and lymphocytes at or above 11-23 mg/kg/day and lymphoid depletion in the spleen and lymph nodes at or above 78-114 mg/kg/day, corresponding to the guidance values for Category 2, were observed, and although the doses were above the guidance value range, a significant decrease in bone marrow cell counts in rats and lymphoid depletion in the spleen, lymph nodes, and thymus and a decrease in bone marrow cell counts in mice were found (Initial Risk Assessment Report, Ministry of Health, Labour and Welfare (Access on August 2011)). Based on the above report, it was classified in Category 2 (hematopoietic system). Besides, as other effects, there is a report of hepatocellular vacuolization in the liver, an increased incidence of nephropathy, lung inflammation, etc., but all were findings at doses exceeding the upper limit of the guidance value range.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 96-hour LC50 = 5,240 mg/L for fish (Pimephales promelas) (AQUIRE, 2012, etc.).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (water solubility = 480,000 mg/L (PHYSPROP Database, 2009)), and it was classified as "Not classified" in acute toxicity.
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.

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