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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	68439-46-3
Chemical Name	Ethoxylated alcohols(C=9-11)
Substance ID	R03-A-004-METI, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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 for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point is 125 deg C (closed cup) (REACH (Accessed May 2021)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 311 deg C (REACH (Accessed May 2021)).
10	Pyrophoric solids	Not classified (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 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).
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.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: between 4,000 mg/kg to 10,000 mg/kg (HERA (2009)) [Reference Data, etc.] (2) LD50 of ethoxylated alcohol (C=6-12) (CAS RN 68439-45-2), which was a mixture containing this substance, in rats (males) (OECD TG 401): > 5,050 mg/kg (REACH registration dossier (Accessed May 2021)) (3) LD50 of ethoxylated alcohol (C=6-12) (CAS RN 68439-45-2), which was a mixture containing this substance, in rats (females) (OECD TG 401): 5,130 mg/kg (REACH registration dossier (Accessed May 2021)) (4) LD50 of ethoxylated alcohol (C=10-16) (CAS RN 68002-97-1), which was a mixture containing this substance, in rats (OECD TG 401): > 5,050 mg/kg (REACH registration dossier (Accessed May 2021))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (HERA (2009)) [Reference Data, etc.] (2) LD50 of ethoxylated alcohol (C=10-16) (CAS RN 68002-97-1), which was a mixture containing this substance, in rabbits: > 2,000 mg/kg (REACH registration dossier (Accessed May 2021)) (3) LD50 of ethoxylated alcohol (C=6-12) (CAS RN 68439-45-2), which was a mixture containing this substance, in rats: > 2,000 mg/kg (REACH registration dossier (Accessed May 2021))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), no category could be identified and classification was not possible. [Evidence Data] (1) LC50 for rats (mist, 4 hours): > 0.22 mg/L (AICIS IMAP (2019), HERA (2009)) [Reference Data, etc.] (2) LC50 of ethoxylated alcohol (C=10-16) (CAS RN 68002-97-1), which was a mixture containing this substance, in rats (aerosol, 4 hours): > 1.6 mg/L (REACH registration dossier (Accessed June 2021))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, application for 4 hours under occluded conditions) for ethoxylated alcohol (C=11, the number of moles of ethylene oxide added was 9 (EO9)) contained in this substance with rabbits, slight irritation was observed but reversed within 6 days (AICIS IMAP (2019)). (2) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, GLP, application for 4 hours under semi-occluded conditions, observation for 72 hours) for ethoxylated alcohol (C=9-11，EO8) contained in this substance with rabbits (n=3), erythema was observed after 24 hours in two cases but completely resolved within 7 days. The primary irritation index (PII) was reported to be 0.6 (HERA (2009)). (3) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, GLP, application for 4 hours under semi-occluded conditions, observation for 72 hours) for ethoxylated alcohol (C=10) (CAS RN: 26183-52-6) contained in this substance with rabbits (n=6), slight erythema was observed but completely resolved within 48 hours (mean erythema score: 0.2, mean edema score: 0) (REACH registration dossier (Accessed May 2021)). [Reference Data, etc.] (4) It was reported that, in a skin irritation test (occlusive application for 24 hours) for ethoxylated alcohol (C=9-11, EO5 to 6) contained in this substance with rabbits, moderate to severe irritation was observed with an undiluted solution, slight to moderate irritation was observed with a 10% diluted solution, and slight irritation was observed with a 1% diluted solution (AICIS IMAP (2019)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) In an eye irritation test (GLP, observation for 14 days) for ethoxylated alcohol (C=9-11, EO6) contained in this substance with rabbits (n=6), all animals developed corneal opacities which were not completely cleared within 14 days after treatment. It was reported that an overall eye irritation index was 41.3 and the maximum irritation score was 53.5 on day 3 (HERA (2009)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a Buehler test (GLP, topical administration: 1% solution) for ethoxylated alcohol (C=9-11, EO6) contained in this substance with guinea pigs (n=10), no skin sensitization reaction was observed (HERA (2009)). (2) It was reported that, in a Buehler test (OECD TG 406, GLP, topical administration: 100% solution) for ethoxylated alcohol (C=11, EO9) contained in this substance with guinea pigs (n=10), no skin sensitization reaction was observed (HERA (2009)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In an in vitro mammalian chromosomal aberration test (single oral dose, 250 to 3,400 mg/kg) (OECD TG 473, GLP) for ethoxylated alcohol (C=12-15, EO3-9) analogous to this substance using hamster or rat bone marrow cells, negative results were reported (AICIS IMAP (2019), HERA (2009)). (2) In a micronucleus test using the bone marrow cells of mice (single-dose intraperitoneal administration, up to 100 or 50 mg/kg) for ethoxylated alcohol (C=12-15, EO3 and C12-14, EO9) analogous to this substance, negative results were reported (HERA (2009)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a two-year study with rats dosed by feeding (concentration: up to 1%) of ethoxylated alcohol (C=12-13, EO6.5 and C=14-15, EO7) analogous to this substance, no increase in tumor incidence was observed (AICIS IMAP (2019), HERA (2009)). (2) In an 18-month dermal toxicity study (up to 5%, 3 times/week) for ethoxylated alcohol (C=12-13, EO6.5) analogous to this substance with mice, no treatment-related neoplastic lesions were observed (AICIS IMAP (2019), HERA (2009)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, in (1) and (2), no reproductive toxicity was observed, but these tests were by dermal administration. In addition, there was no data available on developmental toxicity effects. [Evidence Data] (1) It was reported that, in a two-generation reproduction toxicity study for ethoxylated alcohol (C=9-11, EO6) contained in this substance used as a test substance by dermal administration to rats, no reproductive toxicity was observed (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in a two-generation reproduction toxicity study (GLP) for ethoxylated alcohol (C=9-11, EO6) contained in this substance used as a test substance by dermal administration to rats, no reproductive toxicity was observed (HERA (2009), AICIS IMAP (2019)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified" in the oral route and dermal route. However, classification was not possible due to lack of data since there was no information on toxicity in the inhalation route. [Evidence Data] (1) It was reported that, in a 90-day repeated oral toxicity study with rats dosed by feeding, no signs of toxicity were observed at 3,000 ppm (150 mg/kg/day, in the range corresponding to “Not classified”) (REACH registration dossier (Accessed May 2021), HERA (2009)). (2) It was reported that, in a 90-day repeated oral toxicity study with rats dosed by feeding, lower body weight gain and decreased food intake were observed at 10,000 ppm (400 mg/kg/day, in the range corresponding to “Not classified") (HERA (2009)). (3) It was reported that, in a subchronic dermal toxicity: 90-day study (OECD TG 411, GLP, 3 days/week) with rats, dry, flaky skin, and epidermal thickening with hyperkeratosis were observed at the treated area at or above 10% (approx. 80 mg/kg/day, within the range for Category 2), and relative kidney weight increased at 25% (approx. 200 mg/kg/day, within the range for Category 2) (AICIS IMAP (2018), HERA (2009)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 2.5 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because sufficient data on rapid degradability were not obtained, and it was classified in Category 2 in acute toxicity.
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.
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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