NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	112-75-4
Chemical Name	N,N-Dimethyltetradecan-1-ylamine
Substance ID	R02-A-007-METI, MOE
Classification year (FY)	FY2020
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 was 151 deg C (closed-cup) (GESTIS (Accessed June 2020)).
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 (ECHA (Accessed June 2020)).
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	Classification not possible	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] From (1) - (3), the category with higher hazard was adopted, and it was classified in Category 4. [Evidence Data] (1) LD50 for rats (females) (OECD TG401, GLP): 1,320 mg/kg (REACH registration dossier (Accessed June 2020)) (2) LD50 for rats (males) (OECD TG401, GLP): > 1,600 mg/kg (REACH registration dossier (Accessed June 2020)) (3) LD50 for rats (OECD TG401, GLP): 2,116 mg/kg (REACH registration dossier (Accessed June 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (NICNAS IMAP (2017))
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 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It was classified in Category 2 from (1) - (4). Besides, irreversible effects on the skin surrounding the eye were observed in eye irritation tests in (3) (4), but by judging comprehensively, including data in skin irritation tests in (1) (2), it was classified in Category 2. [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 14-day observation), skin irritation was seen (erythema/eschar score: 2.7/3/2.7, edema score: 1.7/1.3/1.3) (REACH registration dossier (Accessed June 2020)). (2) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 16-day observation), skin irritation was found (erythema/eschar score: 1.7/1/1.3, edema score: 2.3/2/2) (REACH registration dossier (Accessed June 2020)). (3) It is reported that in an eye irritation test with a rabbit (n = 1) (OECD TG 405, GLP, 14-day observation), the conjunctiva showed swelling up to 72 hours, with half-closed or more than half-closed lids, and hyperemia up to a diffuse crimson discoloration. Eye irritation effects completely disappeared within 14 days. Eschar formation was observed on the skin around the eye at 72 hours or later, with 2 cm of the surrounding area, accompanied by a hardening of the skin and total hair loss after 7-14 days. After detaching of eschar, the skin showed a coarsely porous appearance, and the hair roots seemed to be irreversibly damaged. Due to the severe effects on the skin surrounding the eye, these results were interpreted as irreversible damage (corneal opacity score: 0, iritis score: 0, conjunctival redness score: 1.7, chemosis score: 3.7) (REACH registration dossier (Accessed June 2020)). (4) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 22-day observation), skin damage around the eye (hair loss, exfoliation/sloughing) was seen, and conjunctival redness and skin damage around the eye were not fully reversible within 22 days (corneal opacity score: 0/0/0.3, iritis score: 0/1/1, conjunctival redness score: 0.3/1/3, chemosis score: 1.3/0.7/3) (REACH registration dossier (Accessed June 2020)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 22-day observation), skin damage around the eye (hair loss, exfoliation/sloughing) was seen, and conjunctival redness and skin damage around the eye were not fully reversible within 22 days (corneal opacity score: 0/0/0.3, iritis score: 0/1/1, conjunctival redness score: 0.3/1/3, chemosis score: 1.3/0.7/3) (REACH registration dossier (Accessed June 2020)). [Reference Data, etc.] (2) It is reported that in an eye irritation test with a rabbit (n = 1) (OECD TG 405, GLP, 14-day observation), the conjunctiva showed swelling up to 72 hours, with half-closed or more than half-closed lids, and hyperemia up to a diffuse crimson discoloration. Eye irritation effects completely disappeared within 14 days. Eschar formation was observed on the skin around the eye at 72 hours or later, with 2 cm of the surrounding area, accompanied by a hardening of the skin and total hair loss after 7-14 days. After detaching of eschar, the skin showed a coarsely porous appearance, and the hair roots seemed to be irreversibly damaged. Due to the severe effects on the skin surrounding the eye, these results were interpreted as irreversible damage (corneal opacity score: 0, iritis score: 0, conjunctival redness score: 1.7, chemosis score: 3.7) (REACH registration dossier (Accessed June 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Evidence Data] (1) In a bacterial reverse mutation test, negative results were reported (REACH registration dossier (Accessed May 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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	Category 2 (systemic)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] Based on (1) to (2), no target organ could be identified from the signs in the oral route. Therefore, it was classified as Category 2 (systemic toxicity). [Evidence Data] (1) It was reported that in an acute oral toxicity test (OECD TG401, GLP) with rats, at 1,250 to 1,600 mg/kg (within the range for Category 2), reduced spontaneous activity, ruffled fur, crouched posture, irregular breathing, reduced respiratory frequency, uncoordinated gait, bloody crusted eye lids and diarrhea were observed (REACH registration dossier (Accessed June 2020)). (2) It was reported that in an acute oral toxicity test (OECD TG401, GLP) with rats, at 2000 mg/kg (within the range for Category 2), 2/5 male rats and 2/5 female rats died, in which ante mortem signs such as underactivity, staggering gait, hyperpnea, piloerection, ungroomed appearance, pigmented staining of the snout, pigmented orbital secretion and hunched posture were observed, and in surviving animals, similar signs were observed with the addition of hair loss (REACH registration dossier (Accessed June 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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 LC50 = 0.18 mg/L for fish (Oncorhynchus mykiss) (REACH registration dossier, 2021).
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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