NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	61791-26-2
Chemical Name	Ethoxylated tallow alkylamines
Substance ID	R03-A-015-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)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), although it was not classified in Categories 1 to 3, no category could be identified. Therefore, classification was not possible. [Evidence Data] (1) LD50 for rats: > 864 mg/kg (EFSA (2015))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), although it was not classified in Categories 1 to 3, no category could be identified. Therefore, classification was not possible. [Evidence Data] (1) LD50 for rabbits: > 907 mg/kg (EFSA (2015))
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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) This substance is a skin irritant (EFSA (2015)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1), it was classified in Category 2A in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) This substance is severely irritant to the eyes (EFSA (2015)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) This substance is skin sensitizing (EFSA (2015)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Classification not possible." [Evidence Data] (1) In a micronucleus assay using the bone marrow cells of mice, negative results were reported (EFSA (2015)). (2) In a bacterial reverse mutation test, negative results were reported (EFSA (2015)). (3) It was reported that, in an in vitro test, DNA damage was induced at high-dose concentrations causing cytotoxicity (EFSA (2015)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1B. [Evidence Data] (1) It was reported that, in three reproduction toxicity studies (non-guideline) with rats, at a dose (NOAEL: 38 mg/kg/day) at which no general toxicity effects were observed in parental animals, a decrease in the number of implantations and a decrease in litter size were observed in parental animals and lower survival rate in the F1 pups were observed. The NOAEL for parental reproductive toxicity and offspring effects was judged to be 12 mg/kg/day (EFSA (2015)). [Reference Data, etc.] (2) It was reported that in a developmental toxicity study with rats dosed by gavage, no developmental toxicity was observed (Government of Canada, Draft screening assessment (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) and (2), 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. The histological lesions of the intestinal mucosa observed in (1) were considered to be local effects due to irritation and not adopted as a rationale. [Evidence Data] (1) It was reported that, in a repeated dose 90-day oral toxicity study with rats dosed by feeding, histological lesions of the intestinal mucosa were observed and the NOAELs were 19.9 mg/kg/day (males) and 24.1 mg/kg/day (females) (EFSA (2015)). (2) It was reported that, in a repeated dose 14-week oral toxicity study with dogs, lower blood calcium and protein concentrations were observed and the NOAEL was 21 mg/kg/day (EFSA (2015)).
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)	Classification not possible	- -	-	-	Based on expert judgment, there is no data that can be adopted as evidence of classification, and the classification is not possible.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Based on expert judgment, there is no data that can be adopted as evidence of classification, and the classification is not possible.
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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