NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	111-82-0
Chemical Name	Methyl dodecanoate; Methyl dodecanoate; Methyl laurate
Substance ID	m-nite-111-82-0_v2
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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	A flash point is 125 deg C (closed cup) (GESTIS (Access Dec. 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 220 deg C (GESTIS (Access Dec. 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2018	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 liquid substances are not available.	FY2018	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).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2018	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.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2018	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)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 20,000 mg/kg (OECD TG 401, GLP) (SIAR (2013), REACH registration dossier (Accessed Dec. 2018)) (2) LD50 for rats: > 2,000 mg/kg (OECD TG 401) (JECDB (Accessed Dec. 2018), SIAR (2013), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)) (3) LD50 for rats: > 2,000 mg/kg (OECD TG 401, GLP) (SIAR (2013), REACH registration dossier (Accessed Dec. 2018))	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, since the test concentration of 5.6 mg/L (639 ppm) was much higher than the saturated vapor concentration (5.45 ppm) and test air is judged to be a mist, the reference value of a mist was applied. [Evidence Data] (1) LC50 (4 hours) for rats: > 5 mg/L (OECD TG 436, GLP) (SIAR (2013), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017))	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified" (corresponding to Category 3 in UN GHS classification) according to the GHS Classification Guidance for the Japanese Government. Besides, the Draize score in (3) corresponds to Category 3 and PII to Category 2, but it was judged to be "Not classified" after considering comprehensively. Also, after considering the new data, the category was changed from the previous classification. [Evidence Data] (1) There is a report that in a skin irritation test (OECD TG404, GLP-compliant, n=3) with rabbits, as a result of 4-hour semi-occlusive application of the undiluted liquid of this substance, the mean scores of erythema and edema after 24-72 hours were 2.0-2.3 and 1.0-2.3 and they resolved within 7 days (SIAR (2013), REACH registration dossier (Accessed Dec. 2018)). (2) There is a report that in a skin irritation test (OECD TG 404, GLP-compliant, n=6) with rabbits, as a result of 4-hour occlusive application of the undiluted liquid of this substance, only slight erythema was observed in 2/6 animals after 4 and 48 hours, but no edema was observed (SIAR (2013), REACH registration dossier (Accessed Dec. 2018)). (3) There is a report that in a skin irritation test (OECD TG404, GLP-compliant, n=3) with rabbits, as a result of 4-hour application of this substance, the mean scores of both erythema and edema after 24-72 hours were 2, but both resolved within 14 days. Based on this, PII (primary irritation index) is calculated to be 3.89 (SIAR (2013), ECETOC TR 66 (1995)). [Reference Data, etc.] (4) There is a report that when 10-100% solution of this substance was applied to the skin on the inside of the forearms (3 cm diameter) of 60 human volunteers for 30 minutes, no skin irritation was observed (SIAR (2013), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)). (5) There is information that this substance showed negative results in four in-vitro tests including the EpiDerm method and the Episkin method (SIAR (2013)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Besides, as a result of a review of the scores of the test results, this substance is judged not to be irritating. Therefore, the category was changed from the previous classification. [Evidence Data] (1) There is a report that in an eye irritation test (OECD TG 405, GLP-compliant, n=3) with rabbits, as a result of application of this substance, a 0.66 erythema score was observed in 1/3 animals, but the animal recovered within 72 hours, and irritation (corneal opacity, iritis, conjunctival edema, lacrimation) was not observed in 2/3 animals (SIAR (2013), REACH registration dossier (Accessed Dec. 2018)). (2) There is a report that in an eye irritation test (OECD TG 405, GLP-compliant, n=3) with rabbits, as a result of application of this substance, all scores for corneal opacity, iritis, and conjunctival edema were 0 (SIAR (2013), REACH registration dossier (Accessed Dec. 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, because data with n=10 are limited to (1), it is impossible to conclude whether it is sensitizing or not. [Reference Data, etc.] (1) There is a report that in a Maximization test (OECD TG406, GLP-compliant) with guinea pigs (n=10), no positive reaction was observed when induction and challenge were conducted by intradermal injections and epidermal application of solutions of this substance (SIAR (2013), REACH registration dossier (Accessed Dec. 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, bacterial reverse mutation tests, chromosome aberration tests with cultured mammalian cells or human lymphocytes, and mouse lymphoma tests were all negative (JECDB (Accessed Dec. 2018), SIAR (2013), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] It is reported in (1) that no adverse effects on the reproductive performance of parental animals and development of pups were observed even after oral administration up to the limit dose. However, it was impossible to classify it as "Not classified" with only this result since this test was a screening test. In addition, there are also no data from teratogenicity tests. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, no adverse effects on the reproductive performance of parental animals and development of pups were observed even by administration up to the limit dose (1,000 mg/kg/day) (JECDB (Accessed Dec. 2018), SIAR (2013), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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), since transient lethargy was observed, it was classified in Category 3 (narcotic effects). [Evidence Data] (1) In a single exposure study in which rats were exposed by inhalation to 5 mg/L (measured value: 5.6 mg/L) of the aerosol of this substance for 4 hours, lethargy, hunched posture, and labored respiration were observed at 1 hour after exposure, and hunched posture persisted until Day 2 (SIAR (Accessed Dec. 2018), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it is considered to correspond to "Not classified" in the oral route. However, there is no toxicity information on other routes. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage (treatment period: 47 days for males, 41-55 days for females), no treatment-related effects were observed even at a dose of 1,000 mg/kg/day (converted guidance value: 456-611 mg/kg/day) (JECDB (Accessed Dec. 2018), SIAR (2013), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, based on (1) and (2), adverse effects on the respiratory organs by aspiration of this substance are suggested. However, since (1) is not based on specific case reports, and is a content described in precautions for health-care workers, it was not used for the classification. [Reference Data, etc.] (1) There are descriptions that massive inhalation of aerosols or aspiration possibly triggers lung damage, and that ingestion of this substance at high concentrations will probably trigger gastrointestinal disorders and aspiration risk (GESTIS (Accessed Dec. 2018)). (2) The kinematic viscosity at 40 deg C is 2.4 mm2/sec (GESTIS (Accessed Dec. 2018)).	FY2018	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	It was classified in Category 1 from 72-hour ErC50 = 0.017 mg/L for algae (Raphidocelis subcapitata) (SIAR, 2013).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it was rapidly degradable (a 28-day degradation rate by BOD: 78% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1995)) and due to 72-hour NOErC = 0.003 mg/L for algae (Raphidocelis subcapitata) (SIAR, 2013).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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.

To GHS Information