NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	96-48-0
Chemical Name	gamma-Butyrolactone
Substance ID	m-nite-96-48-0_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 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	Not classified	- -	-	-	Its flash point reported 98 degC (closed-cup) (ICSC (J) (2000)) is >= 93 degC.	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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	Since its autoignition temperature is 455 degC (ICSC (2000)), 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 or hydrogen.	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	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	Based on the rat LD50 values of 800 - 1600 mg/kg (IARC 11 (1976)) and 1800 mg/kg (NTP TR 406 (1992)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the guinea pig LD50 value of approximately 5600 mg/kg (IARC 11 (1976)), the substance was classified as "Not classified".	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)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on the results of the study in rats (GLP-compliant) that exposure of 5.1 mg/L caused no mortality and the LC50 value of > 5.1 mg/L (IUCLID (2000)), the substance was classified as "Not classified". Since the test concentration (5.1 mg/L) was higher than the saturated vapor pressure concentration (2.08 mg/L), the criterion values for mist were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	In the rabbit test, application of undiluted substance for 20 hours caused no irritating effects (HSDB (2008)). In other rabbit test, slightly, hardly perceptible or moderate erythema and hardly perceptible edema occurred and resulted as "mildly irritating" (HSDB (2008)). Based on the information, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 3 in the UN-GHS classification). As relevant notes, application of undiluted technical-grade of the test substance to rabbits caused moderate to severe erythema with edema in 3 of 4 animals, and one animal revealed apparent erythema without edema formation after 72 hours of application. Therefore, test substance was concluded as moderate to severe irritating to the skin (HSDB (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In several reports of rabbit tests, there was only one information of the study in conformity with OECD TG 405 and GLP from the "List 1" information source designated in the GHS classification guidance for the Japanese government. The substance was classified as Category 2A based on the report in which the modified maximum average score (MMAS) was 43.9 (maximum score was 110) equivalent to AOI 30 - 80 (ECETOC TR 48 (1998)). In other rabbit tests, some results were reported as follows: irritation effects containing inflammatory irritation and slight corneal opacity (HSDB (2008)), corrosive effects containing severe irritation with conjunctive necrosis, radial damage, corneal opacity and ulceration (HSDB (2008)) and irritation of the conjunctiva, iris and cornea and recovery within 7 days after treatment in 5 of 6 animals (HSDB (2008)).	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	Classification not possible	- -	-	-	In the guinea pig test, skin sensitization was not evident (KemI-Riskline (2004)), however, details of test methods and results were not reported. Therefore, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The classification was concluded as "Not classified" due to negative results in both of two micronucleus test data using bone marrow cells obtained from the mice intraperitoneally administered (in vivo mutagenicity test in somatic cells) (IARC 71 (1999)). As relevant information, as for in vitro studies, negative results in the Ames test (IARC 71 (1999)) and positive results in the chromosome aberration test using Chinese hamster ovary cells (NTP DB (Access on Jul. 2010)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was concluded as "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment (IARC suppl. 7 (1987)). As relevant information, in the 2-year oral administration study in rats and mice, as for rats, no evidence of carcinogenicity of the substance was noted because no increase in the incidence of neoplastic lesions associated with the administration in both sexes was observed. As for mice, ambiguous evidence of carcinogenicity was shown because the incidences of hyperplasia and pheochromocytoma of the adrenal medulla slightly increased in males at low dose, but no evidence of carcinogenicity in females (NTP TR 406 (1992)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the oral administration study using pregnant rats during the organogenetic period, no embryotoxicity were seen (NTP TR 406 (1992)). In the inhalation study using pregnant rabbits during the organogenetic period (OECD TG 414, GLP-compliant), no signs of maternal toxicity and embryotoxicity were observed, and there was no evidence of treatment-related teratogenicity (IUCLID (2000)).　However, because no information was provided regarding sexual functions and fertility of parental animals, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system), Category 3 (narcotic effects)	Warning	H371 H336	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	As for acute toxic effects based on human cases, the following symptoms were described: bradycardia, hypothermia, depression of central nervous system, prolonged unconsciousness, confusion, aggression, torpor, and ataxia (KemI-Riskline (2004)). In fact, unconsciousness was reported in numerous cases who ingested the substance or its products, and the signs concurrently observed included coma, narcosis, convulsions and hypopnea (KemI-Riskline (2004), HSDB (2000)). In the animal study, signs of sedation and loss of righting reflex were described in rats (LD50 value: 1800 mg/kg) following single oral administration (NTP TR 406 (1992)). With regard to the results described above, since information on humans were collected from the "List 2" information source designated in the GHS classification guidance for the Japanese government and the findings of rats corresponded to Category 2 within the range of the guidance values, the substance was classified as Category 2 (central nervous system). Moreover, narcotic effects were also described, so that Category 3 (narcotic effects) was added.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 13-week repeated oral dose studies in rats and mice, deaths occurred at the highest dose level in both species (900 mg/kg/day for rats, 1050 mg/kg/day for mice), suppression of body weight gain and lateral position were found in rats at 450 mg/kg/day or higher, and in mice at 525 mg/kg/day or higher. No toxic effects were seen in rats at 225 mg/kg/day and in mice at 262 mg/kg/day, except for slight to moderate inactivity (NTP TR 406 (1992)). In addition, the NOEL values in the 90-day feeding studies in both rats and dogs were reported as 0.8% (400 mg/kg/day) that exceeded the range of the guidance values (IUCLID, 2000). According to these documents, the classification is considered as equivalent to "Not classified" category in oral route. However, since no sufficient data was available for the other routes (inhalation, dermal), the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible".	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)	Not classified	- -	-	-	Classified as "Not classified" since all LC50 and EC50 values exceeded 100 mg/L in acute toxicity tests for fish, crustacea and algae (IUCLID, 2000).	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 its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility = 1000 g/L (PHYSPROP Database, 2011)).	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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