NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	25339-17-7
Chemical Name	Isodecanol (Isodecyl alcohol)
Substance ID	m-nite-25339-17-7_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)	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.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" based on a flash point of >102 deg C (closed cup) (GESTIS (Accessed June 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 275 deg C (GESTIS (Accessed June 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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) to (6), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 6,500 mg/kg (EFSA (2012)) (2) LD50 for rats: 5,400 mg/kg (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018)) (3) LD50 for rats: 6,400 mg/kg (HSDB in PubChem (Accessed Aug. 2021)) (4) LD50 for rats: 9,800 mg/kg (HSDB in PubChem (Accessed Aug. 2021), Patty (2012)) (5) LD50 for rats: 5,210 mg/kg (GESTIS (Accessed Aug. 2021)) (6) LD50 for rats: 4,720 mg/kg (Patty (2012))	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: 3,150 mg/kg (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018)) (2) LD50 for rabbits:> 2,400 mg/kg (Patty (2012)) (3) LD50 for rabbits:> 2,400 mg/kg (Patty (2012))	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Also, the exposure concentration was higher than the saturated vapor pressure concentration (0.091 mg/L) and it was judged as being in a mist state. [Reference Data, etc.] (1) LC50 (8 hours) for rats:> 0.18 mg/L (converted 4-hour equivalent value: 0.36 mg/L) (PubChem (Accessed Aug. 2021), Patty (2012)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. Besides, since the qualitative findings were obtained from the information source of the List 1, the classification result was changed. [Evidence Data] (1) It was reported that, in a skin irritation test with rabbits, the substances of the oxo alcohols C9 to C13 category were moderately irritating to the skin of rabbits (SIAP (2006), EFSA (2012)). [Reference Data, etc.] (2) It was reported that, in a skin irritation test with rabbits (24-hour application), this substance caused a moderate or severe irritation (HSDB (Accessed July 2021), Patty (6th, 2012)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) It was reported that this substance was a severe eye irritant to rabbits (Patty (6th, 2012)). [Reference Data, etc.] (2) It was reported that the substances of oxo alcohols C9 to C13 category were generally irritating (non-irritating to severely irritating) to the eyes of rabbits (SIAP (2006), EFSA (2012)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) Based on limited data, there was no indication of skin sensitizing potential for the compounds in the oxo alcohols C9 to C13 category (SIAP (2006), EFSA (2012)). (2) In a modified Draize test (intradermal administration: 0.1% solution) with guinea pigs, no skin sensitization reaction was observed (GESTIS (Accessed July 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Also, based on the new findings, classification was changed. [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells of rats, negative results were reported (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018)). (2) As for in vitro, in a bacterial reverse mutation test and in a chromosomal aberration test using cultured mammalian cell (V79 cells), negative results were obtained (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018), HSDB (Accessed July 2021)). [Reference Data, etc.] (3) As for 1-dodecanol (C12 linear alcohol), which is a compound of category members, a micronucleus test with mice was negative. In addition to the results of an in vitro test, compounds of the oxo alcohols C9 to C13 category were considered to be unlikely to present any genotoxic potential (EFSA (2012)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Also, no developmental toxicity effects were observed in (1) and (2), and there was no data about effects on fertility. [Evidence Data] (1) It was reported that, in a developmental toxicity study with rats dosed by gavage (days 6 to 15 of gestation), at the highest dose at which marked general toxicity effects (death/sacrifice in extremis in 4/10 animals) were observed in parental animals, increased embryo resorptions and postimplantation embryo loss, as well as lower body weight, skeletal retardations, skeletal malformations, and a rare malformation (lacked external genitalia) in pups were observed, but at a medium dose, no developmental effects were observed in pups (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018), EFSA (2012), Patty (6th, 2012)). (2) It was reported that, in a different developmental toxicity study from (1) with rats dosed by gavage (days 6 to 15 of gestation), no developmental effects were observed (EFSA (2012)). [Reference Data, etc.] (3) It was reported that, in a combined repeated dose developmental/reproductive toxicity study with the analog 1-dodecanol as a test substance with rats, no reproductive toxicity was observed (SIAP (2006), EFSA (2012)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Since it was reported that central nervous effects were observed in the range thought to be "Not classified" in (1), that irritation to the respiratory tract were observed in (2), and additionally, that it could produce irritation and narcosis in (3), it was classified in Category 3 (narcotic effects, respiratory tract irritation). With the additional new information sources, classification results were changed. [Evidence Data] (1) It was reported that, in an acute oral toxicity test with rats, central nervous effects such as staggering, narcosis, and apathy were observed. Also, the LD50 was between 4,720 mg/kg to 6,400 mg/kg (GESTIS (Accessed Aug. 2021)). (2) It was reported that, in an acute inhalation toxicity test with rats, mice, and guinea pigs (mist, for 6 hours), there was severe irritation to the mucous membrane of the eyes, nose, throat, and respiratory tract at 6.25 mg/L (converted 4-hour equivalent value: 9.38 mg/L, in the range corresponding to "Not classified") (GESTIS (Accessed Aug. 2021), Patty (2012)). (3) There was no report on adverse effects in humans, but it was reported that excessive exposure could produce local irritation and narcosis (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, since (1) was a report on the screening test results, it was not adopted as evidence data. [Reference Data, etc.] (1) It was reported that, in a 14-day oral administration test with rats dosed by gavage, at 168 mg/kg/day (converted guidance value: 26.1 mg/kg/day, within the range for Category 2), there were no effects on body weight, the liver, relative weight of testes, plasma cholesterol, triglyceride, liver tissues and enzyme activity. However, this test was a screening test and the evaluated items were limited to the liver and testes (EFSA (2012), SIAP (2009), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 3.51 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified in Category 3 due to being rapidly degradable (a degradation rate by BOD (similar substances): 88-89% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI)), and 21-day NOEC = 0.7 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified as "Not classified" due to being rapidly degradable, and a low bioaccumulation estimate (log Kow = 3.94 (<4.0, Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2019))), despite 96-hour LC50 = 5.87 mg/L for fish (Oryzias latipes). By drawing a comparison between the above results, it was classified in Category 3. The classification result was revised from the previous classification by changing how to classify it in chronic toxicity and using new information.	FY2021	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.	FY2021	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.

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