NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	68131-39-5
Chemical Name	Poly(oxyethylene) alkyl ether (limited to those the alkyl group is C=12-15 and mixtures thereof)
Substance ID	R03-B-040-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	Revised
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 165.56 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 235 deg C (REACH (Accessed May 2016)).
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 5,000 to 10,000 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 rats: > 2,000 mg/kg (Hazard Assessment Report (CERI, NITE, 2007), 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] Classification not possible due to lack of data.
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	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) It was reported that, as for multiple substances (poly (oxyethylene) = alkyl ether (C=12-14, ethylene oxide addition mole number 6 (EO6), C=12-14, EO3 and C=13, EO3)) contained in this substance, in an acute dermal irritation/corrosion test (OECD TG 404, 4-hour application, observation for 14 days) with rabbits, severe irritation was observed, and the primary irritation index (PII) was 6.3 to 7.1 (AICIS IMAP (2019), HERA (2009)). [Reference Data, etc.] (2) In a skin irritation test with rabbits, 0.5 mL of undiluted solution was applied on the sheared back under occluded conditions. The treated area was washed after 24 hours, and observations for skin reactions were conducted. After 72 hours, re-observations were conducted. It was reported that moderate to severe irritation was observed as a result (Hazard Assessment Report (CERI, NITE, 2007)). (3) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, GLP, semiocclusive, 4-hour application, observation for 21 days) with rabbits (n=3), the mean erythema score was 1.4, and the mean edema score was 0 in all the animals (REACH registration dossier (Accessed May 2021)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It was reported that, as for poly (oxyethylene) = alkyl ether (C=12-13, EO6 and C=14-15, EO7) contained in this substance, in an eye irritation test with rabbits, 0.1 mL of undiluted solution was instilled into the conjunctival sac, and observations were conducted an hour later and everyday until day 7, then every week until recovery, and as a result, severe irritation was observed, and it did not recover even on day 35 (Hazard Assessment Report (CERI, NITE, 2007)). (2) It was reported that, in an eye irritation test with rabbits, an undiluted solution was applied, and severe irritation was observed (AICIS IMAP (2019)). [Reference Data, etc.] (3) It was reported that, in an acute eye irritation/corrosion test (equivalent to OECD TG 405, observation for 7 days) with rabbits (n=3), conjunctival redness was observed, but it was reversible within 7 days (REACH registration dossier (Accessed May 2021)).
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), it was classified as "Not classified." [Evidence Data] (1) It was reported that, as for poly (oxyethylene) = alkyl ether (C=12-15) contained in this substance, in a maximization test (OECD TG 406, intradermal administration: 0.05% solution) with guinea pigs (n=20), the positive rate was 0% both at 24 hours and 48 hours after challenge (REACH registration dossier (Accessed May 2021)). [Reference Data, etc.] (2) It was reported that, as for poly (oxyethylene) = alkyl ether (C=12-13, EO6 and C=14-15, EO7) contained in this substance, 0.5% aqueous solution of this substance was tested for 176 and 144 volunteers respectively, by 3-week (24-hour, every other day, 3-day/week) occlusion applied induction and challenge after 17 days from the last induction. Results of dermal reaction observation after 48 and 96 hours, only 1 volunteer positive at C12-13AE6 application and all volunteers negative at C14-15AE7 application. C12-13AE6 positive volunteer occupationally used cleaning agent containing C12-13AE6 and negative for patch testing of the agent. From the result, the author considered the former positive result was fales positive and concluded the sensitization risk was very low at normal utillization concentration (0.1% was recommended by manufacturer). (Hazard Assessment Report (CERI, NITE, 2007)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of rats or hamsters (250 to 3,400 mg/kg, single oral dose), negative results were reported (AICIS IMAP (2019)). (2) In a bacterial reverse mutation test, negative results were reported (REACH registration dossier (Accessed May 2021), Hazard Assessment Report (CERI, NITE, 2007)). (3) As for poly (oxyethylene) = alkyl ether (C=12-14) contained in this substance, negative results were reported in a mammalian erythrocyte micronucleus test using the bone marrow cells of mice (corresponding to OECD TG474, GLP) (REACH registration dossier (Accessed May 2021)). (4) The view was indicated that comprehensively judging based on the test results available, this substance is not genotoxic (AICIS IMAP (2015)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for poly (oxyethylene) = alkyl ether (C=12-13) and (C=14-15) contained in this substance, in a 2-year feeding administration test with rats, there was no increase in the incidence of neoplastic lesions at doses up to a dose of 1% (10,000 ppm: equivalent to 500 mg/kg/day) (AICIS IMAP (2015), Hazard Assessment Report (CERI, NITE, 2007)). (2) As for poly (oxyethylene) = alkyl ether (C=12-13) contained in this substance, in an 18-month dermal application test with mice, there were no treatment-related lesions at doses up to a dose equivalent to 250 mg/kg/day (AICIS IMAP (2015), Hazard Assessment Report (CERI, NITE, 2007)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was reported that, in a repeated dose 104-week oral toxicity study with rats dosed by feeding, using poly (oxyethylene) = alkyl ether (C=12-13) contained in this substance as the test substance, an increasing tendency in absolute liver weight (males), a decrease in absolute heart weight (females), and increases in relative weight of the liver, kidney, and brain (females) were observed at 250 mg/kg/day (in the range corresponding to "Not classified"), and decreases in absolute weight of the heart and kidney (males), an increase in relative liver weight (males), and a decrease in absolute kidney weight (females) were observed at 500 mg/kg/day (in the range corresponding to "Not classified") (Hazard Assessment Report (CERI, NITE, 2007)). (2) It was reported that, in a repeated dose 104-week oral toxicity study with rats dosed by feeding, using poly (oxyethylene) = alkyl ether (C=14-15) contained in this substance as the test substance, a decrease in absolute brain weight (males) was observed at 250 mg/kg/day (in the range corresponding to "Not classified"), and increases in relative weights of the liver, gonad, and thyroid, a decrease in absolute adrenal gland weight (males), an increase in relative brain weight (males), decreases in absolute weights of the liver, kidney, heart, and thyroid (females), and increases in relative kidney and heart weights (females) were observed at 500 mg/kg/day (in the range corresponding to "Not classified") (Hazard Assessment Report (CERI, NITE, 2007)). (3) It was reported that, in a repeated dose 18-month dermal administration test with mice (3 days/week) using poly (oxyethylene) = alkyl ether (C=12-13) contained in this substance as the test substance, there were no dose-dependent effects at 10 mg/kg/day (converted guidance value: 4.29 mg/kg/day, within the range for Category 1) (Hazard Assessment Report (CERI, NITE, 2007)). (4) It was reported that, in a repeated dose 13-week dermal administration test with rabbits (5 days/week) using poly (oxyethylene) = alkyl ether (C=12-13) contained in this substance as the test substance, moderate skin irritation was observed at 20 mg/kg/day (converted guidance value: 14.3 mg/kg/day, within the range for Category 1), and moderate to severe skin irritation with erythema, edema, fissure, scale formation, and desquamation was observed at 50 mg/kg/day (35.7 mg/kg/day, within the range for Category 2) (Hazard Assessment Report (CERI, NITE, 2007)). (5) It was reported that, in a repeated dose 13-week dermal administration test with rabbits (5 days/week) using poly (oxyethylene) = alkyl ether (C=14-15) contained in this substance as the test substance, mild skin irritation was observed at 50 mg/kg/day (converted guidance value: 35.7 mg/kg/day, within the range for Category 2) (Hazard Assessment Report (CERI, NITE, 2007)).
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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour EC50 = 0.7 mg/L for algae (Raphidocelis subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN) and it was classified in Category 1 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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