NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	88-09-5
Chemical Name	2-Ethylbutanoic acid
Substance ID	24A6064
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and 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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	It corresponds to Category 4 from a flash point of 87 deg C [closed-cup] (Ullmanns (E) (6th, 2003)) > 60 deg C and <= 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 345 deg C (Ullmanns (E) (6th, 2003)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that there were no dead animals in a test by the administration of 2,000 mg/kg to rats (OECD TG401, GLP), and an LD50 value was > 2,000 mg/kg (JECDB (2001)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	There is a description of an LD50 value of 480 mg/kg for rabbits (PATTY (5th, 2001)), which was questionable because it means much higher toxicity compared to oral toxicity, but it was impossible to confirm the original article, and the details are unknown. Therefore, it was classified as "Classification not possible."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Data are lacking. Besides, it is reported that there were no deaths after 8-hour exposure to the saturated vapour in rats (PATTY (5th, 2001)), but the category cannot be determined. Therefore, it was classified as "Classification not possible."
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification) because it is described that it was a mild irritant in a test by a 24-hour application of 10 mg of the test substance to the rabbit skin (PATTY (5th, 2001)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It was classified in Category 1 because it is described that an application of a 5% solution to the rabbit eye caused severe burns (PATTY (5th, 2001)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after oral administration to mice [OECD TG 474, GLP] (in vivo somatic cell mutagenicity test) (JECDB (2004)). Besides, as for in vitro tests, it is reported that it was negative in an Ames test (JECDB (2001)), positive in a chromosomal aberration test with CHL/IU cells derived from Chinese hamster lung (JECDB (2001)), and negative in a chromosomal aberration test with Chinese hamster fibroblasts (PATTY (5th, 2001)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 422, GLP), in the high dose (250 mg/kg) group in which transient salivation, a slight decrease in leukocytes, and an increase in kidney weights were observed as repeated dose toxicity, a decrease in the number of live borns as well as significant decreases in the birth index and live birth index were shown, and the number of live pups on day 4 of lactation decreased (JECDB (2001)). Therefore, it was classified in Category 2. Besides, there are no reports on adverse effects on the development of offspring including teratogenicity in a test by oral administration to pregnant rats during the organogenesis period, or a test by subcutaneous administration to pregnant mice on gestational day 8 (PATTY (5th, 2001)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In an acute toxicity test by oral administration of 2,000 mg/kg to rats (OECD TG401: GLP), transient salivation in 3/10 animals and rale in 4/10 animals were observed within 1 hour after administration, and as for rale, one animal showed it for several days, and rale occurred later in one animal, but rale stopped by the time of necropsy. No anomalies related to the administration of this substance were found at necropsy conducted on day 15 of observation (JECDB (2001)). From the above, because no serious toxicity effects were observed at 2,000 mg/kg, it corresponds to "Not classified" in the oral route. However, because effects in the other routes are unknown due to no data, it was classified as "Classification not possible" for specific target organ toxicity (single exposure).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 422, GLP), at the examination at the time of necropsy, leukocyte count slightly decreased in males at or above 50 mg/kg/day (converted guidance value: about 25 mg/kg/day), platelet count decreased in males, and kidney weights slightly increased in males and females at 250 mg/kg (converted guidance value: about 125 mg/kg/day), but no anomalies were observed at histopathological examination (JECDB (2001)). From the above, because all the found changes were slight, no treatment-related anomalies were seen, and no findings suggesting adverse effects were obtained within the guidance value range, it corresponds to "Not classified" in the oral route. However, because effects in the other routes are unknown due to no data, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure). Besides, there is a report on a 90-day diet administration test with rats, and it is only described that it caused reductions in food consumption and weight gain at or above 1.25% (converted guidance value: 625 mg/kg/day) (PATTY (5th, 2001)).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available. Besides, because this substance is a liquid at normal temperatures, and the kinematic viscosity was 3.6 mm2/s at 20 deg C, it may correspond to Category 2 in UN GHS classification.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 70 mg/L for crustacea (Daphnia magna) (SIAP (Conclusions Agreed in SIAM 23, 2006)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, there are data: 72-hour NOEC = 39 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000); SIAP (Conclusions Agreed in SIAM 23, 2006)). However, it is rapidly degradable (readily biodegradable, BOD: 93% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law)), and low bioaccumulation is estimated (LogKow = 1.68 (NITE, 2012)). Therefore, it is classified as "Not classified." If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, there are data: 96-hour LC50 = 85 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, 2000)). However, it is rapidly degradable (readily biodegradable, BOD: 93% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2001)), and low bioaccumulation is estimated (LogKow = 1.68 (NITE, 2012)). Therefore, it is classified as "Not classified." From the above results, it was classified as "Not classified."
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.

To GHS Information