NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	112-18-5
Chemical Name	N,N-Dimethyldodecan-1-ylamine
Substance ID	H30-B-005-METI, MOE
Classification year (FY)	FY2018
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	FY2008
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point is 118 deg C (closed cup) (GESTIS (Accessed Sept. 2018)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	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 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 applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

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) and (2), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 1,890 mg/kg (male), 1,450 mg/kg (female) (SIDS (2004), Environmental Risk Assessment for Chemical Substances vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)) (2) LD50 for rats: 1,000-1,250 mg/kg (NICNAS IMAP (Accessed Oct. 2018))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, the USCh, the information source used in the previous classification, has already been closed to the public, and evidence data could not be confirmed.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)
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)-(3), it was classified in Category 1 according to the GHS Classification Guidance for the Japanese Government. Besides, although Category 1A is suggested from the information in (2), sub-categorization was not conducted since the information in (3) was also obtained. [Evidence Data] (1) It is reported that this substance is severely irritating to human skins (Environmental Risk Assessment for Chemical Substances vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (2) There is a report that in a skin irritation test (OECD TG 404) with rabbits, both of the two products with different purities (the content of this substance: 95%, 70%) were corrosive after application for 4 hours or 3 minutes (SIDS (2004)). (3) There are reports that in the skin irritation test (OECD TG 404) with rabbits, in all of two tests showing corrosivity and one test showing irritation, in which a 3-minute or 4-hour application was followed by a 1-hour observation, the erythema scores were lower than 4, and the criteria of Category 1A were not met (NICNAS IMAP (Accessed Oct. 2018)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Because this substance was classified in Category 1 in Skin corrosion/irritation and based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It is reported that this substance is severely irritating to human eyes (Environmental Risk Assessment for Chemical Substances vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (2) It is reported that this substance showed severe eye irritation in a test (Draize test) with rabbits (NICNAS IMAP (Accessed Oct. 2018)).
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] Based on (1)-(3), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) A negative result is reported in an in-vivo micronucleus test with mice (SIDS (2004)). (2) As for in vitro, a negative result is reported in a bacterial reverse mutation test (SIDS (2004), NITE Toxicity and Eco-toxicity Tests (2001)). (3) As for in vitro, a negative result is reported in a chromosomal aberration test with cultured mammalian cells (NITE Toxicity and Eco-toxicity Tests (2001)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] As for carcinogenicity, there is no available report on humans. Animal test result is limited to (1). Therefore, classification was not possible due to lack of data. [Evidence Data] (1) There is a report that in a test in which drinking water supplemented with 0.18% of this substance alone or with a combination of 0.18% of this substance and 0.2% of sodium nitrite was orally administered to rats for 80 weeks, no increase in a tumor incidence was observed in the group supplemented with this substance alone. On the other hand, a significant increase in tumor incidence of the urinary bladder and forestomach in the sodium nitrite supplemented group was observed, and the authors considered that combined use produced the carcinogen, nitrosamine (CIR (Cosmetic Ingredient Review) (2009)). (2) There are no classification results by domestic and international organizations.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] In (1), developmental toxicity effects such as embryo/fetal death and growth suppression in the womb of maternal animals were observed in the 150 mg/kg/day administration group. However, because they are findings at the dose with mortality in maternal animals: 20% (mortality of parental animals: above 10%), there is the high possibility that they are secondary effects of maternal toxicity. Therefore, it is considered inappropriate to consider this result as evidence of the classification. There is no other information available for classification. Therefore, classification was not possible due to lack of data. In the previous classification, it was classified in Category 2 based on (1), but as for the results for this study, it was considered inappropriate as evidence since the mortality of the parental animals exceeded 10%, and the classification results were changed. [Reference Data, etc.] (1) There is a report that in a reproductive/developmental toxicity screening test (OECD TG421) with rats dosed by gavage, deaths of parental animals were observed, and in the group of 150 mg/kg/day, 2 maternal animals died, and that in the group of 150 mg/kg/day, other than this, increased pre-implantation embryonic loss in parental animals, and in pups, decreased number of pups alive at birth, increased number of stillbirths, and decreased birth weight of male pups were observed. Moreover, mortality of maternal animals was high, and no offspring was obtained at doses higher than this (SIDS (2004), Environmental Risk Assessment for Chemical Substances vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010), NICNAS IMAP (Accessed Oct. 2018)).
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). Besides, in (1), the doses where symptoms are manifested are not clear, but since the LD50 values are 1,000-1,250 mg/kg, symptoms are assumed to be within the range of Category 2. [Evidence Data] (1) There is a report that in a single oral administration test with rats, symptoms below sublethal doses were lethargy, diarrhea, piloerection, and changes of activity, and that symptoms at sublethal doses in other test were bloody crust of the eyelids and mouths, labored breathing, and diarrhea. The LD50 value is found to be between 1,000 and 1,250 mg/kg (NICNAS IMAP (Accessed Oct. 2018)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] The target organs cannot be identified from (1) and (2) in the oral route, and there is no toxicity information on other routes. Therefore, it was classified as "Classification not possible" due to lack of data. Besides, according to (1), effects on the heart were observed at doses within the range of Category 1, but no relevant changes were observed in the guideline study (2) in which the higher doses were administered, so the heart is not adopted as the target organ. In addition, findings on the forestomach and the glandular stomach observed in (1) are considered to be effects by local irritation, and these are also not adopted as the target organ. According to (2), there were death cases at doses within the range of Category 2, but histopathological examination of survivors did not reveal any findings that could be used to estimate the cause of death or to identify the target organ. [Evidence Data] (1) There is a report that in a 28-day test (OECD TG 407) with rats dosed by gavage, focal myocardial degeneration or fibrosis in males, proliferation of squamous epithelium of the forestomach mucosa in females at or above 20 mg/kg/day (converted guidance value: 6.2 mg/kg/day) within the range of Category 1, similar findings for the forestomach in males and females, and thickening of wall, erosion, and edema in deeper layer in the forestomach, and increased leukocytes in the glandular stomach mucosa in both sexes at 100 mg/kg/day (converted guidance value: 31.1 mg/kg/day) within the range of Category 2 were observed (NITE Toxicity and Eco-toxicity Tests (Accessed Oct. 2018), Environmental Risk Assessment for Chemical Substances vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). (2) There is a report that in a 28-day test (OECD TG 407) with rats dosed by gavage, behavior such as rubbing their noses against the bedding material was observed at 150 mg/kg/day (converted guidance value: 46.7 mg/kg/day) within the range of Category 2, and similarly, at 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day) within the range of Category 2, deaths of 3/5 of females were observed, but no abnormalities in histopathological examination were found in the survival animals (SIDS (2004), Environmental Risk Assessment for Chemical Substances vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010), NICNAS IMAP (Accessed Oct. 2018)).
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 (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour EC50 (growth rate) = 0.014 mg/L for algae (Desmodesmus subspicatus) (OECD SIDS: 2001).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to rapid degradability (readily biodegradable, an average degradation rate by BOD: 74% (J-CHECK, 1999)), and 72-hour NOEC (growth rate) < 0.0026 mg/L for algae (Desmodesmus subspicatus) (OECD SIDS: 2001).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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.

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