NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	9002-92-0
Chemical Name	Poly(oxyethylene) dodecyl ether
Substance ID	R03-A-017-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	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
5	Gases under pressure	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
6	Flammable liquids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
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	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
10	Pyrophoric solids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
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)	- -	-	-	Classification not possible since its physicochemical properties are unknown.
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 4. [Evidence Data] (1) LD50 for rats (females) (OECD TG 423, GLP): in the range from 300 to 2,000 mg/kg (REACH registration dossier (Accessed May 2021)) (2) LD50 for rats: 1,190 mg/kg (REACH registration dossier (Accessed May 2021)) (3) LD50 for rats: 1,000 mg/kg (REACH registration dossier (Accessed May 2021))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats (OECD TG 402, GLP): > 2,000 mg/kg (REACH registration dossier (Accessed May 2021)) (2) LD50 for rats (OECD TG 402): > 2,000 mg/kg (REACH registration dossier (Accessed May 2021))
1	Acute toxicity (Inhalation: Gases)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible since its physicochemical properties are unknown.
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	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 an acute dermal irritation/corrosion test (OECD TG 404, GLP, semiocclusive, 4-hour treatment, 72-hour observation) with rabbits (n=3), no skin irritation was observed (erythema score：0/0/0, edema score：0/0/0) (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, occlusive, 4-hour treatment, 14-day observation) with rabbits (n=3), slight erythema was observed in all the animals at 24 hours after removal of the patch, but it disappeared after 48 hours (erythema score: 0.3/0.3/0.3, edema score: 0/0/0) (REACH registration dossier (Accessed May 2021)). [Reference Data, etc.] (3) It was reported that, in an in vitro skin irritation test (OECD TG 439), the cell viability was R = 2.7% (REACH registration dossier (Accessed May 2021)).
3	Serious eye damage/eye irritation	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 an acute eye irritation/corrosion test (OECD TG 405, GLP, 14-day observation) with rabbits (n=3), effects on the conjunctiva were observed in all the animals until 7 days later, but they disappeared after 14 days (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 1.7/1.7/2, chemosis score：1/1.3/1) (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, 21-day observation) with rabbits (n=3), corneal opacity and effects on the conjunctiva were observed in all the animals (corneal opacity score: 0.7/0.7/0.7, iritis score: 0/0/0, conjunctival redness score: 1/1.7/1.7, chemosis score: 1/1/1) (REACH registration dossier (Accessed May 2021)). [Reference Data, etc.] (3) It was reported that, in an in vitro eye irritation test (OECD TG 492), the mean tissue viability was 34.4% (classified as unpredictable) (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, in a patch test (10%, 15%, 20% solution, occlusive) for 51 subjects, no positive reactions were observed (REACH registration dossier (Accessed May 2021)). [Reference Data, etc.] (2) It was reported that, in a Draize test (intracutaneous injection: 0.02% or 0.1% solution) with guinea pigs (n=7), no skin reactions were observed after a challenge (REACH registration dossier (Accessed May 2021)). (3) It was reported that, in a skin sensitization test (epicutaneous, occlusive: 1% solution) with rabbits (n=12), no skin reactions were observed after a challenge (REACH registration dossier (Accessed May 2021)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (3-day intraperitoneal injection), negative results were reported (REACH registration dossier (Accessed May 2021), Hazard Assessment Report (CERI, NITE, 2007), NTP CEBS (Accessed May 2021)). (2) In a chromosomal aberration test using the bone marrow cells of mice (single-dose intraperitoneal injection), negative results were reported (NTP CEBS (Accessed May 2021)). (3) In a bacterial reverse mutation test, negative results were reported (REACH registration dossier/NTP CEBS (Accessed May 2021), Hazard Assessment Report (CERI, NITE, 2007)). (4) In a gene mutation test using the mouse lymphoma cells, negative results were reported (REACH registration dossier/NTP CEBS (Accessed May 2021), Hazard Assessment Report (CERI, NITE, 2007)). (5) In a chromosomal aberration test using the cultured mammalian cells (CHO), negative results were reported (REACH registration dossier/NTP CEBS (Accessed May 2021)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Based on the data of (1), it was classified as "Not classified", however, in consideration of (2), it was classified as "Classification not possible." [Evidence Data] (1) It was reported that, in a 2-year carcinogenicity study of this substance (ethoxylated dodecyl alcohol) with rats and mice dosed by feeding, the results were negative in both females and males (Haseman et al., Environ. Health Perspect., 74 (1987), Hazard Assessment Report (CERI, NITE, 2007)). (2) The results in (1) were based on the Testing Report (TR-264) of NTP, however, they were considered to be insufficient as a test report, and the relevant TR was already deleted from the DB of NTP (NTP DB (Accessed May 2021)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in two two-generation reproduction toxicity studies with rats dosed by feeding and by dermal application, no reproduction toxicity was observed (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in a two-generation reproduction toxicity study with rats dosed by feeding using this substance (C12, EO6) as the test substance, no reproduction toxicity was observed (Hazard Assessment Report (CERI, NITE, 2007)). (3) It was reported that, in a developmental toxicity study with rats dosed by feeding (days 6-15 of gestation), no developmental toxicity was observed (REACH registration dossier (Accessed May 2021)). (4) It was reported that, in a test (from pre-mating through the mating, gestation, and lactation periods) with rats by oral administration of this substance (C12, EO4) as the test substance, no abnormalities were observed in mating, gestation, delivery, and lactation (Hazard Assessment Report (CERI, NITE, 2007)). (5) It was reported that, in a developmental toxicity study with rats and rabbits by oral administration of this substance (C12, EO4) as the test substance, teratogenicity and fetal toxicity were not observed (Hazard Assessment Report (CERI, NITE, 2007)).
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3 (narcotic effects). [Evidence Data] (1) It was reported that, in an acute oral toxicity test with rats, mild lethargy (6/6 animals), and soiled anal region by diarrhea and feces and urine were observed at 300 mg/kg (within the range for Category 1); mild lethargy (1/3 animals), mild to moderate lethargy (2/3 animals), ataxia, and abnormal breathing were observed at 2,000 mg/kg (within the range for Category 2); and wet area around anal region, and red discoloration of all lobes in the lungs were observed at the necropsy in two rats that died (REACH registration dossier (Accessed May 2021)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was no information on toxicity in the other routes. [Evidence Data] (1) It was reported that, in a repeated dose 28-day oral toxicity study with rats dosed by feeding, no toxicity effects were observed at 590 mg/kg/day (in the range corresponding to "Not classified") (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 72-hour ErC50 = 0.237 mg/L for algae (Desmodesmus subspicatus) (REACH registration dossier, 2021, Bull. Environ. Contam. Toxicol., 2006 76:218-225).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it was not rapidly degradable (a 14-day degradation rate by BOD in standard method: 38% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law (Ministry of Economy, Trade and Industry (METI), 1982))) and due to 72-hour NOEC = 0.07383 mg/L for algae (Desmodesmus subspicatus) (Bull. Environ. Contam. Toxicol., 2006 76:218-225).
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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