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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	104-76-7
Chemical Name	2-Ethyl-1-hexanol
Substance ID	25B0055
Classification year (FY)	FY2013
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	FY2010
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
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 was classified in Category 4 from a flash point of 73 deg C (closed-cup) (GESTIS (Access on December (2013))).
7	Flammable solid	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 231 deg C (HSDB (Access on December (2013))).
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 in the molecule.
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	- -	-	-	There are reports on six LD50 values for rats of 2,053 mg/kg, 3,200 mg/kg, 3,250 mg/kg, 3,730 mg/kg, 3,200-6,400 mg/kg, and 2,049-7,000 mg/kg (JECFA FAS32 (1993), DFGOT vol. 20 (2003), PATTY (6th, 2012)), and it was classified as "Not classified" (Category 5 in UN GHS classification) to which four of them corresponded.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	There are reports on LD50 values for rats of > 2,000 mg/kg and > 3,000 mg/kg (DFGOT vol. 20 (2003)) and LD50 values for rabbits of 1,986 mg/kg, > 2,000 mg/kg, and > 2,600 mg/kg (JECFA FAS32 (1993), DFGOT vol. 20 (2003), PATTY (6th, 2012)), and it was classified as "Not classified" to which most data corresponded. Data in JECFA FAS32 (1993) and PATTY (6th, 2012) were added, and the category was reviewed.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that there were no deaths in vapour inhalation tests with rats, at 0.89 mg/L (4 hours) (DFGOT vol. 20 (2003), IUCLID (2000)), or by exposure to the saturated vapour (0.953 mg/L) (8 hours) (converted 4-hour equivalent value: 1.35 mg/L) (JECFA FAS32 (1993), PATTY (6th, 2012)), but the classification is not possible because these data did not enable determining to which category an LC50 value corresponded. Besides, because the above values were higher than 90% of the saturated vapour pressure concentration of 0.953 mg/L, a reference value in the unit of mg/L was applied as a vapour with mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that there were no death cases at 1.2 mg/L (6 hours) (converted 4-hour equivalent value: 1.8 mg/L) (JECFA FAS32 (1993), DFGOT vol. 20 (2003), PATTY (6th, 2012)), and all animals died at 5.3 mg/L (a mixture of aerosol/vapour) (4 hours) (DFGOT vol. 20 (2003), IUCLID (2000)), but the classification is not possible because these data did not enable determining to which category an LC50 value corresponded. Besides, because the above values were higher than the saturated vapour pressure concentration of 0.953 mg/L, a reference value in the unit of mg/L was applied as mist.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It is reported in DFGOT vol. 20 (2003) that in a test (OECD TG 404) in which the undiluted test substance was applied to rabbit skin for 4 hours, there was severe irritation with reddening, edema, and scar formation, and the skin irritation score was 6.75/8.0, and that slight reddening and edema formation after 24 hours and marked peeling after eight days were observed in a 20-hour occlusive exposure test with rabbits. It was classified in Category 2 based on the above information.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is reported in DFGOT vol. 20 (2003) that in a test in which 0.1 mL of the undiluted test substance was applied to rabbit eyes (OECD TG 405), there was moderate to severe irritation of the cornea, iris, and conjunctiva, and the eye irritation score was 28.59/110. And it is reported in ECETOC TR48 (1998) that in a test in which 0.1 mL of the undiluted test substance was applied to the conjunctival sac of rabbit eyes, corneal opacity, iritis, and redness and chemosis in the conjunctiva were observed after 24 hours, the eye irritation score (MMAS) was 51.3/110, and these disappeared after 7-14 days. It was classified in Category 2A based on the above information.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that in a skin sensitization test in 29 volunteers by the Kligman method (a maximization test), no one showed sensitization reactions, and it is described that the occupational medicine department of a manufacturing and processing company reported that this substance was not a skin sensitizer (DFGOT vol. 20 (2003)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a dominant lethal test with mice and negative in a micronucleus test with mouse bone marrow cells and a chromosomal aberration test with rat bone marrow cells (DFGOT vol. 20 (2003)). As for in vitro, it was negative in all of a bacterial reverse mutation test, an hprt gene mutation test, a mouse lymphoma test, and a chromosomal aberration test with cultured mammalian cells (DFGOT vol. 20 (2003), IUCLID (2000), JECFA (1998), NTP DB (Access on September 2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There was no classification for the carcinogenicity of this substance by international organizations. Besides, in carcinogenicity tests (US-TSCA guideline) with male and female rats and mice, by oral administration for two years for rats, and 18 months for mice, it is concluded that this substance was not carcinogenic (JECFA FAS32 (Access on September 2013), DFGOT vol. 20 (2003), IUCLID (2000)). And there are no inhalation test data.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	After oral administration to rats on day 12 of gestation, there was no report on maternal toxicity, but an increased incidence of malformed fetuses such as hydronephrosis, tail anomalies, and malformed limbs was observed (DFGOT vol. 20 (2003)). Furthermore, in a developmental toxicity test by oral administration during the organogenesis period of rats, an increase in skeletal malformations was found in addition to clear increases in resorptions and post-implantation losses and an increase in fetuses with dilatation of the renal pelvis and hydroureter at the dose where maternal animals showed deaths, general symptoms, decreased food consumption, and reduced weight gain. And it is concluded that this substance was teratogenic only at doses that caused maternal embryo/fetotoxicity (DFGOT vol. 20 (2003)). Therefore, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs), Category 3 (narcotic effects)	Warning	H371 H336	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	It is reported that occupational exposure to this substance causes headaches, dizziness, fatigue, intestinal disorders, and a slight decrease in blood pressure in humans (PATTY (6th, 2012)). In animals tests, it is reported that in a single inhalation administration test with mice, rats, and guinea pigs (1.8 mg/L/4 hours, mist (converted from exposure to 227 ppm for 6 hours)), lung hemorrhage, reversible central nervous system depression, and irritation of the mucous membranes of the eyes, nose, throat, and respiratory passages were observed (JECFA FAS32 (1993), DFGOT vol. 20 (2003)). Therefore, it was classified in Category 2 (respiratory system), Category 3 (narcotic effects, respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	From descriptions in DFGOT vol. 20 (2003), PATTY (6th, 2012), and JECFA FAS 32 (1996), no toxicity effects were seen at the doses within the range for Category 1-2 in any of 13-week or 2-year gavage administration or 13-week diet administration tests with rats, and an 18-month gavage administration test with mice, and effects on the liver (increased weights, peroxisome proliferation, etc.), kidney (cortical degeneration), and forestomach (hyperplasia of the epithelium) were observed at the doses above the range for Category 2. On the other hand, in a 90-day inhalation test with rats exposed to the vapour of this substance, no toxicity effects were found at up to the highest concentration (120 ppm; 0.65 mg/L), but the test concentrations did not cover the guidance value range for Category 2, toxicity effects at the upper limit of the guidance values are unknown, therefore it was judged as insufficient data to use for the classification. And there are no data on dermal exposure available for classification. From the above, it corresponds to "Not classified" in the oral route. However, because of insufficient toxicity information on the other routes, it was classified as "Classification not possible" due to lack of data as a whole.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 10 mg/L for fish (Lepomis macrochirus) (AQUIRE, 2013).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified in Category 2 in acute toxicity. However, it is rapidly degradable (a degradation rate by BOD = 99.9, 79.0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)), and low bioaccumulation is estimated (LogPow = 2.28 (IUCLID, 2000)). Therefore, 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.

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