NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	2082-79-3
Chemical Name	n-Octadecyl 3-(4'-hydroxy-3',5'-di-t-butylphenyl) propionate
Substance ID	m-nite-2082-79-3_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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 350 deg C (GESTIS (Access on June 2016)).	FY2016	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.	FY2016	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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	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.	FY2016	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	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data.	FY2016	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	- -	-	-	Based on the LD50 value (OECD TG 401) of > 5,000 mg/kg for rats (SIDS (2006)), the substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value (OECD TG 402) of > 2,000 mg/kg for rats (SIDS (2006)), the substance was classified as "Not classified."	FY2016	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)	FY2016	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)	FY2016	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, although it is reported that LC50 (4 hours) for rats is > 1,811 mg/m3 (converted value: 1.811 mg/L)(SIDS (2006)), it is not possible to identify classification only with this value.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is described that in a skin irritation study (OECD TG 404) using rabbits exposed to an undiluted solution of this substance for 24 hours, no irritation was observed (SIDS (2006)). Therefore, this substance was classified as "Not classified" based on the description that this substance is not regarded as a skin irritant (SIDS (2006)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In an eye irritation study (OECD TG 405) using rabbits, no irritation was observed (SIDS (2006)). Therefore, this substance was classified as "Not classified" based on the description that this substance is not regarded as an eye irritant(SIDS (2006)) .	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	It is reported that in a skin sensitization study (optimization study) using guinea pigs, no sensitization potential was found (SIDS (2006)) but this study was not in accordance with OECD test guidelines. For humans, it is reported that in a skin patch by the challenge after 9-time exposure to this substance in 50 human subjects (Caucasian, 26 males and 24 females, age 22-50 years), no evidence of sensitization was found (SIDS (2006)). However, because there is no negative data other than this report, it was classified as "Classification not possible" due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo data, a dominant lethal assay using mice was negative, and both micronucleus assay and chromosome aberration test using Chinese hamster bone marrow cells were negative (SIDS (2006)). As for in vitro data, the bacterial reverse mutation test was negative (SIDS (2006)). From the above, the substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	No carcinogenicity data available for humans. As for experimental animals, in a 2-year oral administration study (feeding) using rats or mice no increased incidence of tumours related to treatment was found (SIDS (2006)). However, because there is no classification by other organizations for carcinogenicity, and no carcinogenicity information on other exposure routes (such as inhalation) than oral route is available, the substance was classified as "Classification not possible" due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two generation study using rats administered (feeding) by the oral route, in the F0 and F1 generation parent animals, reduction in body weight gain and in feed consumption (F0), increased relative liver weights (F0, F1) and centrilobular hepatocyte enlargement (F1) etc. were observed at high doses (5,000 ppm), but no effects on fertility were found (SIDS (2006)). However, in F1 and F2 generation pups, a decrease in live pups per litter at birth (F1) and a decrease in survival index on Day 4 (F1, F2) postpartum were observed at 5,000 ppm, and effects on development of offspring were indicated (SIDS (2006)). 　On the other hand, as a result of gavage administration to pregnant rats or pregnant mice at up to 1,000 mg/kg/day during the organogenesis period, only a decrease in feed consumption in maternal animals and minor developmental effects in the fetus (lower foetal body weight, delayed ossification) were observed in rats (SIDS (2006)). 　From the above, the substance was classified in Category 2 because in a two generation study using rats developmental effects on offspring were observed at doses where general toxicity in parental animals is manifested.	FY2016	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. 　There is no single exposure data of this substance in humans. As for experimental animals, it is reported that in a single-dose study by inhalation using rats, ruffled fur and ventral posture were observed at 0.5 mg/L/4h, which is within Guidance value range of Category 1 (SIDS (2006)). Moreover, it is reported that in a single-dose study by oral administration using rats, diarrhoea, sedation, dyspnoea and hunched posture were observed at 5,000 mg/kg, which is above Guidance value of Category 2 (SIDS (2006)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data available for humans. 　As for experimental animals, in an inhalation toxicity study using rats and repeated dose toxicity studies using rats, mice or dogs administered by feeding, hepatocyte hypertrophy and an increase in liver microsomal enzymes etc., considered to be an adaptive response, were observed (SIDS (2006)). However, no effects which become classification basis were observed within the range of up to Category 2. Therefore, the classification is not possible.	FY2016	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.	FY2016	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)	Not classified	- -	-	-	From 72-hour EbC50 of > 11.3 mg/L for algae (Desmodesmus subspicatus), 24-hour EC50 of > 100 mg/L for crustacea (Daphnia magna), and 96-hour LC50 of > 100 mg/L for fish (Lepomis macrochirus) (all SIDS, 2007), it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 21-39 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)), 72-hour EbC10 of < 0.5-1 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2007). 　If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because the data of acute toxicity either for crustacea or for fish corresponds to "Not classified," it is not rapidly degradable (a degradation rate by BOD: 21-39 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)), and it is estimated to be low bioaccumulative (BCF was < 1.2-8.4, < 12- when test concentration was set to be 0.5 mg/L and 0.05 mg/L (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)). 　It was classified in Category 2 by drawing a comparison between the above results.	FY2016	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.	FY2016	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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