NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	112-53-8
Chemical Name	Dodecan-1-ol
Substance ID	m-nite-112-53-8_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)	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)	- -	-	-	Solid (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)	- -	-	-	Solid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	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 (Not applicable)	- -	-	-	Solid (GHS definition)	FY2018	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 250 deg C (ICSC (J) (2013)).	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 solid (melting point <= 140 deg C) 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)	- -	-	-	Solid (GHS definition)	FY2018	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.	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	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.	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), it was classified as "Not classified." [Evidence Data] (1) LD50 value for rats: >12.8 mL/kg (about 10,600 mg/kg) (SIDS (1995), PATTY (6th, 2012))	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 value for guinea pigs: >10 mL/kg (about 8,300 mg/kg) (SIDS (1995))	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] Solid (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)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, although the LC50 value is difficult to calculate, there is information on it (1). [Reference Data, etc.] (1) Rats were exposed by inhalation to this substance at 1.05 mg/L for 1, 6 or 18 hours, but no death in animals was observed (SIDS (1995)). Besides, although it is a solid according to the definition of GHS classification, it may have been treated as a liquid in the test because it has a melting point of 24 deg C. There is no description of the test conditions, and it cannot be determined whether the test was performed on the dust or the mist.	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" (Category 3 in UN GHS classification). Besides, since the application period in (4) is short and in (5), the applications of the melt by rising temperature, they were not used for classification. [Evidence Data] (1) There is a report that no irritation was observed in a patch test (OECD TG 404, GLP) in which the undiluted liquid of this substance (Lorol C12-98) was applied semi-occlusively to 20 subjects (22-53 years old (average of 34.9 years old)) for 4 hours (SIDS Dossier (2006), REACH registration dossier (Accessed Oct. 2018), DEFGOT (2006)). (2) There is a report that as a result of getting a 4% solution of this substance in petrolatum in contact with the skin of 25 volunteers for 48 hours, no irritation was observed (PATTY (6th, 2012), HSDB (2015)). (3) There is a report that in a skin irritation test (OECD TG 404, GLP) with rabbits, when a 10% solution of this substance (Kalcol 2098) was semi-occlusively applied for 4 hours, the erythema score was 1, the edema score was 0.3, and the primary irritation index (PII) was 1.3, and since they resolved after 7 days, it corresponds to Category 3 in UN GHS classification (SIDS Dossier (2006)). [Reference Data, etc.] (4) There is a report that in a Burckhardt test in which the undiluted liquid of this substance (Lorol C 12-98) was applied to 20 subjects for 1 hour, no irritation was observed (SIDS Dossier (2006)). (5) There is a report that in a skin irritation test (OECD TG404, GLP) with rabbits, this substance (Kalcol 2098), having melted at 40 deg C, was applied semi-occlusively for 4 hours, and as a result, the erythema score was 2, the edema score was 1.7 and the primary irritation index (PII) was 3.5, and these resolved after 7 days (SIDS Dossier (2006)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1), it was classified in Category 2B. Besides, as for (2) and (3), since the details of the test substance were unknown, they were not used for classification. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits (OECD TG405, GLP, n=6), as a result of application of the undiluted liquid of Neodol 91 (C8: <1%, C9: 18%, C10: 48%, C11: 38%, C12: 1%), an iris score of 0, a corneal opacity score of 0.17, a conjunctival score of 0.39, and a conjunctival edema score of 0.5 were obtained. All symptoms resolved within 7 days, and the Maximum mean total score (MMTS) was 8.8/110 (REACH registration dossier (Accessed Oct. 2018)). [Reference Data, etc.] (2) There is a report that in an eye irritation test (OECD TG405) with rabbits, this substance (technical grade) did not show irritation (DFGOT vol.22 (2006)). (3) There is a report that in an eye irritation test with rabbits (OECD TG405, GLP, n=6), as a result of application of the undiluted liquid of this substance (purity, etc. unknown), although slight to moderate corneal opacity, erythema and conjunctival edema were observed, 5 animals recovered within 72 hours, the remaining one animal became worse and also showed slight iritis (REACH registration dossier (Accessed Oct. 2018)). (4) There is a report that in an eye irritation test with rabbits, as a result of application of the commercial products A or B (both of C10-C18 mixtures) containing 63.3% or 68.9% of this substance (n=3 (unwashed), 3 (washed)), mainly slight irritation symptoms of the conjunctiva were observed in both products after one hour, and while most scores became zero within 3-4 days, one animal required 14 days to recover (SIDS (1995)).	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	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." Besides, it was difficult to judge the presence or absence of sensitization since a mixture was used in (5) and irritant reactions were also included in (6) and (7), therefore, they were not used for classification. The category was changed from the previous category by adopting the new information sources. [Evidence Data] (1) There is a report that in a Maximization test with 25 human volunteers, no sensitization was observed after application of a 4% petrolatum preparation (SIDS (1995), HSDB (2015), PATTY (6th, 2012)). (2) There is a report that in a Maximization test with guinea pigs (OECD TG406, GLP, test group 10 animals/group, control group 5 animals/group), no sensitization was observed after occlusive application of 10% of this substance (Kalcol 2098: C12 >98%) (SIDS Dossier (2006), REACH registration dossier (Accessed Oct. 2018)). (3) There is a report that in a Maximization test with guinea pigs (OECD TG406, test group 20 animals/group, control group 10 animals/group), no sensitization was observed after application of 25% of this substance (Dobanol 23: C12-13) (REACH registration dossier (Accessed Oct. 2018)). (4) There is a report that in a Maximization test with guinea pigs (OECD TG406, test group 20 animals/group, control group 10 animals/group), no sensitization was observed after application of 2.5% of this substance (Dobanol 25; C12-16) (REACH registration dossier (Accessed Oct. 2018)). [Reference Data, etc.] (5) There is a report that in a Buehler test (OECD TG406, GLP) with guinea pigs, although 2 tests were conducted with Neodol 91 (C8: < 1%, C9: 18%, C 10: 48%, C 11: 38%, C 12: 1%) and Neodol 23 (C 11: < 1%, C 12: 41%, C 13: 58%, C 14: < 1%), no irritation was observed (REACH registration dossier (Accessed Oct. 2018)). (6) When a 5% or 10% petrolatum preparation of this substance was applied to 1,664 eczema patients, 4 positive reactions were observed in 5% and 15 positive reactions were observed in 10%. However, there is a report that it is difficult to make a judgment based on the result of this test since irritation reactions are considered to be also included (SIDS (1995)). (7) There is a report that as a result of application of a 30% preparation of this substance to 51 patients with contact allergy to wool wax alcohol (lanolin alcohol), 22 patients showed positive reactions, 9 of whom showed erythema, redness, bullous papula, etc. of grade 2+ or 3+ at 24, 48 and 72 hours after application (SIDS (1995)).	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] Based on (1) and (2), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) It was negative in an in vivo micronucleus test with mouse bone marrow (OECD TG474, GLP, single oral administration, 5,000 mg/kg) (SIDS (1995)). (2) As for in vitro, it was negative in a bacterial reverse mutation test (SIDS (1995)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] As for carcinogenicity, there are no available reports on humans. (1) and (2) are not test results through the normal exposure route. In addition, there are no classification results by domestic and international organizations. Therefore, classification was not possible due to lack of data. [Reference Data, etc.] (1) As a result of intraperitoneal administration of this substance to mice three times a week for 8 weeks (total dose: 2,400, 12,000 mg/kg), pulmonary tumors were observed in the treated group, but there was no significant increase in the incidence, and no increase in the incidence of tumors was also observed in other organs (SIDS (1995)). (2) In a 440-day (10 mg/times) dermal application test with mice to evaluate the potential of this substance as a co-carcinogen in combination with a known carcinogen initiator, no significant increase in the skin tumor incidence was observed in combination with the initiator, and no skin tumor incidence was observed in the group of this substance alone (SIDS (1995)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to the data in (1), reproductive and developmental effects were not detected at doses up to the limit dose in the oral administration, but it was not possible to classify as "Not classified" because it is a screening test. Also, since no other data are available for classification, it was classified as "Classification not possible." [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by feeding, although a tendency to decrease the fertility rate was observed at 2,000 mg/kg/day, the highest dose, there was no significant difference, and reproductive and developmental effects were not detected even at the limit dose (SIDS (1995)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] According to (1), effects on the lung were observed within the dose range of Category 1-Category 2. Since there is no description of the time when the symptoms were found, the category with the higher hazard was adopted, and it was classified in Category 1 (respiratory organs). The category was changed from the previous classification. Besides, as for (1), there is no description of the test conditions and it cannot be determined whether the test was conducted on the dust or the mist. [Evidence Data] (1) In a single inhalation exposure test with male rats given 1.05 mg/L of this substance for 1-18 hours (converted 4-hour equivalent value: 0.27 mg/L-4.7 mg/L), there were no dead animals, and as for symptoms, decreased general activity, slight dyspnea, and scattered hemorrhage in the lung of a few animals at necropsy were observed (SIDS (1995)).	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), in oral administration, no toxicological findings were observed by which the target organ can be identified within or lower than the dose range of Category 2. Other than this, there are no data available for classification. 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 feeding for 41-45 days in males and for about 54 days in females, at or above 100 mg/kg/day (converted guidance value: at or above 46 mg/kg/day), within the range of Category 2, although a slight decrease in the total leukocyte counts was observed, there was no change in the percentage of leukocytes, and it is described that the toxicological significance is unclear. In addition, a decrease in erythrocyte counts was observed at or above 500 mg/kg/day (converted guidance value: at or above 228 mg/kg/day) exceeding the range of Category 2 (SIDS Dossier (2006), SIDS (1995), PATTY (6th, 2012)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] There is no finding in humans. Therefore, classification was not possible due to lack of data. Besides, it is a primary normal alcohol composed of carbon atoms of not less than 3 and 13 or less and (1)-(3) show an aspiration hazard to experimental animals, so it corresponds to Category 2 in UN GHS classification. [Evidence Data] (1) A 0.2 mL (188 mg/animal) of this substance was dosed in the mouth of male rats, and aspirated. As a result, 9/10 animals died, 7 of which died within 30 minutes. There is a report that the cause of death was massive, extensive, and severe pulmonary hemorrhage (SIDS (1995), PATTY (6th, 2012)). (2) In rats, a small amount of this substance behaves like a hydrocarbon solvent, causing death due to pulmonary edema (HSDB (2015)). (3) The kinematic viscosity of this substance is 21.7 mm2/s (20 deg C) (ISCS (J) (2013)) and is expected to be 14 mm2/s or less also at 40 deg C.	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 96-hour LC50 = 0.9 mg/L for crustacea (Nitocra spinipes) (OECD SIDS: 2002).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	It was classified in Category 3 due to rapid degradability (readily biodegradable, judged by comparison with degradability of related compounds (J-CHECK, 2012)), and 96-hour EC10 (unknown effects) = 0.73 mg/L for algae (Desmodesmus subspicatus) (OECD SIDS: 2002).	FY2018	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.	FY2018	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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