NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	149-57-5
Chemical Name	2-Ethylhexanoic acid
Substance ID	m-nite-149-57-5_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.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified	- -	-	-	Not classified because of its flash point: 118 to 120degC	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified	- -	-	-	Flash point: 371degC (ICSC (J), 1996; Solvent Pocket Book , 1997)	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 metaloids(B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen (but not chlorine and fluorine) chemically bonded only to carbon and hydrogen (but not to other elements).	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no -0-0- structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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)	Not classified	- -	-	-	LD50 value of the oral administration test employing a rat 1,600-3,200 mg/kg (ACGIH (7th, 2001)), There is description with 1,600 mg/kg (Patty (5th, 2001)), 3,640 mg/kg, 3,270 mg/kg, and 2,043 mg/kg (IUCLID (2000)). There are much data in which LD50 value 2,043 mg/kg of GLP based test falls within the range of "Not classified" and exists "Not classified". Although LD50 value 2,043 mg/kg corresponded to the U.N. GHS acute toxicity Category 5, it fell under unadopted category in Japan and was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	It describes LD50 value 1,140 mg/kg (ACGIH (7th, 2001)) and 1,260 mg/kg (Patty (5th, 2001)) of the dermal administration test employing a rabbit, and describes LD50 value >2,000 mg/kg (IUCLID (2000)) of the dermal administration test employing a rabbit (OECD TG 402, GLP). Although there was a result pursuant to OECD TG and corresponding to "Not classified", since there were two or more data equivalent to Category 4 in the information source of List1, it was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	It is a liquid whose saturated vapor pressure level at 20degC is 0.23 mg/L.. Since it is written that there was no mortality even if rats were exposed to saturated steam for 8 hours in the 8-hour inhalation exposure test employing rats (ACGIH (7th, 2001)), 4-hour equivalent LC50 value is >0.46 mg/L when applying the vapor standard, and classification cannot be specified, and classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	It is a liquid whose saturated vapor pressure level at 20degC is 0.23 mg/L.. Since it is written that there was no mortality even if rats were exposed to 2.36 mg/L for 6 hours in the 6-hour inhalation exposure test employing rats (Patty (5th, 2001)), 4-hour equivalent LC50 value is >3.54 mg/L. when applying the mist standard. Since classification cannot be specified, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	There are descriptions, "Although undeluted liquid caused slight edema, erythema and necrosis, deluted liquid by 20% caused no or very slight edema and slight to moderate reddening" (Patty (5th, 2001)) in the study of 24 hour dermal administration to guinea pig and "slight necrosis in 5 animals and subsequent formation of slight to moderate crusts ," also in the 4 hour administration of undeluted liquid to 6 rabbits. Furthermore, there are descriptions "corrosive" in 3 cases of the 24 hour dermal stimulation study of rabbits, one of which is the result of the rabbits study in 1986 mentioned above. Although there is a description, on the other hand, "not irritating" in the dermal stimulation study (OECD TG 404, GLP) using rabbits in IUCLID (2000), delution conditions are unknown, because the primary document is a company report. Since there was a dose-dependent datum on guinea pig in the year 1955 and the existence of 3 cases in IUCLID (2000) where data were evaluated as "corrosive" without any description about recoverability could not be neglected, it was classified in Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In ACGIH (7th, 2001), there is a description of "This substance was evaluated to Level 5 at ten steps of classifications from the research results of two cases on the eye damage on a rabbit." In IUCLID (2000), there are descriptions of "irritating at 5% and only trace injury at 1%" in the eyes irritation test where the diluent was trickled into the eye of a rabbit and of "not irritating " in the irritation to eyes of a rabbit /corrosion test (OECD TG 405, GLP). On the other hand, as a human case, there is also a description of "Although there was one case of conjunctival injury, it recovered quickly. " (Patty (5th, 2001)). Since the examination in conformity to OECD TG was a corporate data and the dilution ratio was unknown, it was not classified finely and was classified into "Category 2". In addition, as for the eye irritation test employing another rabbit, although there is a description of "severe corneal necrosis" in ACGIH (7th, 2001), there are descriptions of "irritating" in IUCLID (2000) and of "severe corneal irritation" Patty (5th, 2001), and the evaluations are divided. As for this data, the evaluations are divided depending on the information source and primary literature J.Ind.Hyg.Toxicol.26 (1944) also has described as "Accuracy is not sufficient since it is a Range Finding Test", it is not adopted.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification is not possible because there is no data of in vivo examination. In addition, in an in vitro mutagenicity test, there are descriptions of "positive", in chromosome aberration test and SCE test employing the CHO culture cells (NTP DB (Access on January 2009)) and "negative" (Patty (5th, 2001)) in the Ames test employing Salmonella typhimurium.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	Since no evaluation by major international evaluation agencies is made and there is no data, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There was a description as follows in the study where it was orally administered in the form of drinking water as sodium salt in 100-600mg/kg to rats of 6-19 day pregnancy, " Although decrease in mother animals' body weight was observed at a high dose level, there was no effect below that level, and abnormalities in the bone structure such as club fold, hyperdactylia and fibular deficiency were dose dependently observed among fetuses" (Patty (5th, 2001)). When the primary literature of this study (Fundam. Appl. Toxicol. 19 (1992)) was thoroughly reviewed, there was a description as follows, "Although the number of fetuses per litter whose bone structure deformation was observed dose dependently increased compared with the control group, clubbed feet are the most serious bone structure deformation, "and NTP-CERHR (2000) describes as follows regarding this study, "There was no deformation other than clubbed feet thet showed statistically significant increase. Wavy ribs as skeletal variants increased in all administered groups." Furthermore, there is a description as follows in the study where it was administered in the form of drinking water as sodium salt in 100-600mg/kg to female rats from 2weeks before mating and during the periods of pregnancy and nursing and for 10 weeks to male rats before mating, "Among females in the highest dose group effects were hardly observed other than decrease in food consumptions and body weight and no histopathological change was observed in males' epididymis, testis, prostate and seminal capsule and non-pregnant females' ovaria, uterus and vagina. When mating with males of the highest dose group, however, conception was delayed and the number of fetuses per litter decreased" (Patty (5th, 2001)). For the reasons stated above, we classified it as Category 1B. Incidentally, there is a description as follows in Patty (5th, 2001) and ACGIH (7th, 2001), "Although neither teratogenicity nor fetal toxicity was observed in (S) body, (R) body showed high rate of exencephalia expression and the racemic body showed effects of an intermediatary degree between the two"in the study that administered to mice respective sodium salt of (R) body, (S) body and the racemic body into the ventral cavity once in the daytime and once at night on the 7th and 8th days of pregnancy, which relates the difference of fetal toxicity levels with the fact that this substance is the racemic body.. EU Classification is Repr.Cat.3; R63 (EU-Annex I).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	ACGIH (7th, 2001) has descriptions that "transient weakness was foreseen" in the trial which asks for oral lethal dose of rats, and that "clinical signs were not seen" within the limits of guidance value of Category 2 in the trial which carried out inhalation exposure by the saturation vapor pressure pressures higher concentrations in rats. On the other hand, the paragraph of the human impacts of HSDB (2008) which is the information source of List 2 has a description that "possibility that the dropsy of the larynx by inhalation and a bronchus, a spasm and chemical pneumonia, and a lung blister are fatal", therefore, it classified into Category 2 (respiratory systems).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 13 weeks mixed feed administration test employing rats and mice, the weight, weight gain, and intakes declined slightly" in both of rat and the mouse out of the range of the guidance value of Category 2, and the hepatocellular hypertrophy and eosinophilia of liver were seen. There is a description that the basophilic leukocytosis in the cytoplasm of a proximal convoluted tubule in mice and the acanthosis and hyperkeratosis of proventriculus in male mice have been seen."(Patty (5th, 2001)). Although material impacts are not seen in the oral route, since the influence on the inhalation route and dermal route are unknown, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	It was classified into Category 3 from 48-hour EC50=85.4mg/L of Crustacea (Daphnia magna) (IUCLID, 2000).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Classified into Category 3, since acute toxicity was Category 3 and rapid degradability is unknown, though supposed less bio-accumulative (log Kow=2.64 (PHYSPROP Database, 2005)).	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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