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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	103-24-2
Chemical Name	Bis(2-ethylhexyl) azelate; Bis(2-ethylhexyl) nonanedioate
Substance ID	25A0064
Classification year (FY)	FY2013
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)	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	Not classified	- -	-	-	From a flash point of 211 deg C (unknown test method) (SDS by Tokyo Chemical Industry Co., Ltd. (2013)) above 93 deg C, it was classified as "Not classified."
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 this substance does not ignite at normal temperatures from autoignition temperatures of 340 deg C for di-(ethyl-2-hexyl) adipate (GESTIS (Access on August 2013)) and 400 deg C for bis(2-ethylhexyl) sebacate (GESTIS (Access on August 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	- -	-	-	It was classified as "Not classified" based on reports on LD50 values for rats of > 2,000 mg/kg (JECDB (Access on October 2013), SIDS (2004)) and 7,978 mg/kg (PATTY (6th, 2012)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on a report on an LD50 value of 18,300 mg/kg for rabbits (PATTY (6th, 2012)).
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.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported in HSDB (Access on October 2013) that slight irritation (1 on a scale of 1-10) was observed 24 hours after application of this substance to rabbits, but the details are unknown.
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.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There are no in vivo data, and as for in vitro, it was negative in a bacterial reverse mutation test and a chromosomal aberration test with cultured mammalian cells (JECDB (Access on September 2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422) with rats in the oral route (gavage), no reproductive/developmental effects were observed except that prolongation of estrus cycle was found in females at 1,000 mg/kg/day as fertility effects. Because the finding was seen at the dose where increased weights of the liver and kidney were observed (JECDB (Access on October 2013)), adverse fertility effects were thought to exist. However, it was judged to be not sufficient to assign a category for reproductive toxicity because it is a screening test. Furthermore, because there are no sufficient reports on developmental toxicity, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is described that no toxic signs were observed after gavage administration (2,000 mg/kg) to rats (JECDB (Access on October 2013)). Therefore, it corresponds to "Not classified" in the oral route. However, due to no information on the other routes, it was classified as "Classification not possible."
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats by gavage administration, only effects on the liver (increased weights, centrilobular hypertrophy of hepatocytes) were observed at the dose (467 mg/kg/day (converted guidance value)) above the guidance value range for Category 2 (JECDB (Access on October 2013)). Therefore, it corresponds to "Not classified" in the oral route. However, because of no toxicity information on the other routes, the classification is not possible due to lack of data.
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)	Not classified	- -	-	-	It was classified as "Not classified" due to 72-hour ErC > 0.08 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 > 0.093 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 0.072 mg/L for fish (Oryzias latipes) (all from Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)), and because acute toxicity is not reported at concentrations near the water solubility.
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 95% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2004)), 96-hour NOEC > 0.08 mg/L for algae (Pseudokirchneriella subcapitata), and 21-day NOEC > 0.064 mg/L for crustacea (Daphnia magna) (SIDS, 2008). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, there are data: 96-hour LC50 > 0.072 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, 2002)). It is rapidly degradable (a degradation rate by BOD: 95% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2004)), but high bioaccumulation is estimated (log Kow = 11.9 (> 4.0, SIDS, 2008)). 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.

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