NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	1643-20-5
Chemical Name	N,N-Dimethyldodecylamine N-oxide
Substance ID	m-nite-1643-20-5_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (N-oxides) present in the molecule, and the calculated oxygen balance (value: -296) is less than the criteria: -200. However, because there are no data on exothermic decomposition energy and onset temperature, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (N-oxides) present in the molecule, but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	Because its use is surfactant, it is estimated that it does not ignite in contact with the air at normal temperatures, but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on a reported LD50 value of 1,267 mg/kg for rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)), it was classified in Category 4. Based on the high priority information, the category was revised.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that the LC50 value (4 hours) was 5.3 mg/L (a converted value equivalent to this substance: 0.016 mg/L) when rats were exposed by inhalation to the mist of a hair spray containing 0.3% of this substance (water: 85-95%, PVP/VA copolymer: 1-5%, cocamide DEA: 0-2%, polyquaternium-11: 0-2%, other: <1%) (SIDS (2007)). However, the category cannot be specified only with this data. Besides, based on the description that the hair spray was supplied by aerosol in the test, a reference value of mist was applied.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that in a skin irritation test with rabbits, severe irritation was observed as a result of the application of this substance for 24 hours (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), HSDB (Access on October 2015)), but this was not used for the classification because it was a test of application for 24 hours.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a report that in an eye irritation test with rabbits, severe irritation was observed after a 1% solution of this substance was applied (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In other eye irritation tests with rabbits, it is reported that mild irritation was observed by applying this substance at 30% and no irritation was observed by the application of this substance at 0.3% (SIDS (2007)). It is reported in SIDS (2007) that oxidized amine compounds including this substance do not show any irritation at low concentrations, but severe irritation was seen at around 30% concentration (SIDS (2007)). From the above, based on the report that severe irritation was observed, it was classified in Category 2A.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	There is a report that no sensitization was observed in the maximization test with guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), and there are multiple reports that in patch test reports on human (84, 101, 141 subjects), no sensitization was seen (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). It was concluded in SIDS (2007) that this substance did not show sensitization (SIDS (2007)). From the above, it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a mouse dominant lethal test was negative. As for in vitro, bacterial reverse mutation tests were negative (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Therefore, it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In carcinogenicity tests in which female and male rats were orally dosed (drinking water) with this substance at 1,000 ppm for 93 weeks, a combined administration group of 1,000 ppm of this substance and 2,000 ppm of sodium nitrite, in addition to the 1,000 ppm dose group of this substance alone, was set, and the presence or absence of carcinogenicity was compared. As a result, no evidence of an increase in tumor incidence was shown in the single administration group compared with the untreated control group, whereas in the combined group of this substance and sodium nitrite, an increased incidence of liver tumors (hepatocellular adenoma) was observed when compared with the group dosed with sodium nitrite alone (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Other than this, there are reports of a 2-year feeding study with rats and a 2-year dermal application test with mice using the test substance (C10-16 AO (CAS RN: 70592-80-2)), which is a 27% aqueous solution product which is a commercially available product of alkyldimethyl N-aminoxide (AO), and contains 95% or above of C10-C16 linear alkylaminoxide and C12 as the main component. In the high-dose group, it was administered at up to the doses where a decreased body weight gain was seen in the feeding test and where a thickening of skin due to skin irritation was seen in the dermal application test. And neither showed evidence of carcinogenicity (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). From the above, there was no evidence of carcinogenicity either for rats in the oral route (drinking water) of this substance, or for rats in the oral route, or for mice in the transdermal route of a commercially available aqueous solution containing this substance. In drinking water administration in rats, an increased incidence of hepatocellular adenoma in the liver was observed when this substance and the nitrite were dosed concomitantly. It is difficult to evaluate the carcinogenicity of this substance from the result of the combined administration with a nitrite, and it is considered that the possibility of carcinogenicity in this substance itself is low from the result of the single administration. However, there is only one report from a test of dosing this substance of certain purity and this is the drinking water administration (1,000 ppm) in rats. The information on such as dose response relationship and the difference between animal species is missing, so it is not possible to classify due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a two-generation reproductive toxicity test in which this substance was administered orally (feeding) to rats, since a reduced body weight was seen 6.5 weeks after starting administration to F0 parent animals, the doses were reduced; the parent animals of F0 and F1 generations were dosed at doses equivalent to 11-40 mg/kg/day and the test was continued until the weaning of the F2 pups. As a result, a suppressed weight gain was observed in the parent animals, but there were no adverse effects on fertility and in the pups of F1 and F2, only a transition of low body weight during the lactation period was seen from the low dose group (SIDS (2007)). As for a developmental toxicity study, in a study in which this substance was administered by gavage to pregnant rats at up to 200 mg/kg/day on gestational days 7-17, 2/3 of animals were caesarean sectioned on day 20 of gestation, the fetuses of which were observed; the remaining animals were allowed to deliver naturally, F1 animals were mated with each other at 10 weeks of age after breeding, and sacrificed on day 20 of gestation, a suppressed body weight gain (slightly, <10%) and a decreased water consumption at 200 mg/kg/day in F0 maternal animals, a reduction of the placenta weight at 200 mg/kg/day in F1 maternal animals, and a reduced fetal body weight and an ossification delay at 200 mg/kg/day in fetuses (F1) were observed (SIDS (2007)). Similarly, in a test in which this substance was administered by gavage to pregnant rabbits at 40-160 mg/kg/day on gestational days 6-18, suppressed body weight gain and decreased food and water consumption at or above 40 mg/kg/day in maternal animals were observed, and at 80 and 160 mg/kg/day, each 3 cases were dead or euthanized due to moribundity, but no abnormalities were observed in fetuses of the surviving animals (SIDS (2007)). As described above, in the reproductive and developmental toxicity tests by the oral route of this substance, there were no adverse effects on the fertility of the parent animals and only minimal developmental effects were seen in the fetuses or pups at doses where maternal toxicity was manifested. No toxicity information available for classification was obtained, and it was judged that information was insufficient to classify it as "Not Classified." Therefore, it was classified as "Classification not possible" due to lack of data for this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for the test report in which this substance was administered, there is only the test report of drinking water administration (0.1%) with rats shown below. The information such as the dose response relationship and difference between animal species is missing. Therefore, it could not be classified due to lack of data. No toxic effects were observed in a test in which 0.1% of this substance (equivalent to 250 mg/kg/day) was administered by drinking water to rats for 93 weeks (SIDS (2007)). Other than this, in a 104-week feeding study, although it is not an administration of this substance alone, an aqueous solution product containing 27% of alkyldimethylamine oxides (AO, alkyl chain length C12-C16, and dodecyl (C12) as a main component) (however, the proportion of DDNO contained in AO is unknown) administered to rats showed a suppressed body weight gain, observed in females and males in the 0.2% administration group (100 mg/kg/day as AO). In addition, in a 104-week study in which the same aqueous solution product containing 27% of alkyldimethylamine oxides (AO, alkyl chain length C12-C16, dodecyl (C12) as a main component) was dermally administered to mice, thickening of the skin was observed, but no systemic toxicity was seen (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). In a study in which the product containing 0.3% of this substance was applied to rabbits at 2 mL/kg/day, 5 days/week for 4 weeks, there were only local effects at the application site, and systemic toxicity was not observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2007)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	From 72-hour EC50 = 0.1 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Due to being not rapidly degradable (4-week BOD: 54, 52, 82%, TOC: 68, 54, 81%, LC-MS: 100, 100, 100% (Official Bulletin of Ministry of International Trade and Industry, 1995)), and 72-hour NOEC (r) = 0.004 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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