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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	947-04-6
Chemical Name	Dodecane-12-lactam
Substance ID	25A0017
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/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 by the Japanese Government (July, 2013)
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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solid	Classification not possible	- -	-	-	No data available.
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	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 320-330 deg C (SIDS (2005)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	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 applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification) based on a report on LD50 values for rats of 2,330 mg/kg (OECD TG 401) and 2,600 mg/kg (SIDS (2005), Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on a report on an LD50 value of > 2,000 mg/kg for rats (SIDS (2005)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because it was assessed to be not irritating in a 4-hour application test with rabbits (OECD TG 404) in SIDS (2005).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It was classified as "Not classified" because it was assessed to be not irritating in two application tests with rabbits (OECD TG 405) in SIDS (2005).
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	It is reported in SIDS (2005) that it was negative in a maximization test with guinea pigs (OECD TG 406), which was conducted with the number of animals according to the guideline (20). However, because there was no positive control, it was judged to be a limited test, and it was classified as "Classification not possible."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There are no in vivo data. As for in vitro, it was negative in a bacterial reverse mutation test, a chromosomal aberration test with human lymphocytes, and a gene mutation test with cultured mammalian cells (SIDS (2005)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, in a developmental toxicity test with rats in the oral route (gavage), developmental toxicity was not seen even at the doses where maternal toxicity was observed (SIDS (2005), Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). No reports on fertility were obtained.
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system, digestive system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	After oral administration to rats (OECD TG 401), within the guidance value range for Category 2 (500-1,990 mg/kg), mainly symptoms that are thought to be via the central nervous system were observed, including crouched posture, closed eyes, salivation, prone position, lateral position, staggering, tremor, convulsion, straub tail reaction, and vocalization when being touched, and the symptoms remained by day 11 after the dose (SIDS (2005)). Necropsy of dead animals showed hyperemia of the gastrointestinal tract, hyperemia of the lung, light-colored spots on the liver and liver congestion, and hyperemia of the gastrointestinal tract was also found in the necropsy of the surviving animal. Therefore, it was classified in Category 2 (central nervous system, digestive system).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 90-day oral exposure test with rats, ground-glass appearance of centrilobular hepatocytes in the liver was observed at the dose (25 mg/kg/day) within the guidance value range for Category 2 (SIDS (2005), IUCLID (2000)), but there were no changes in liver weights or serum enzyme. It was judged that it was an adaptive change to the foreign body rather than a toxicity effect (SIDS (2005), IUCLID (2000)). Furthermore, also in a 13-week or 14-week diet administration test with dogs, effects on the liver were found at the dose (350 mg/kg/day) above the guidance value for Category 2 (SIDS (2005), IUCLID (2000)). Therefore, it corresponds to "Not classified" in the oral route. However, because of no toxicity information on the other routes, it was classified as "Classification not possible" due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	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 3	- -	H402	P273 P501	From 24-hour EC50 = 41 mg/L for crustacea (Daphnia magna) (SIDS, 2005), it was classified in Category 3.
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (a 4-week degradation rate by BOD = 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1988)), and 21-day NOEC (reproduction) = 14 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1988)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (a 4-week degradation rate by BOD = 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1988)), and 96-hour LC50 = 55 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998)). By drawing a comparison between the above results, it was classified in Category 3.
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.

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