NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	112-02-7
Chemical Name	Hexadecan-1-yl(trimethyl)ammonium chloride
Substance ID	H30-B-003-METI, MOE
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2008
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 solids	Classification not possible	- -	-	-	No data available. Besides, it is described that it is poorly flammable (GESTIS (Accessed Sept. 2018)).
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	Classification not possible	- -	-	-	No data available.
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 chlorine (but not fluorine or oxygen) which is ionically bonded to the element other than carbon or hydrogen (N) and does not contribute to oxidization.
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. [Evidence Data] (1) LD50 for mice: between 400-600 mg/kg (deaths in 3/10 animals at 400 mg/kg, and 10/10 animals at 600 mg/kg) (Hazard Assessment Report (CERI, NITE, 2009), NICNAS IMAP (Accessed Sept. 2018)) (2) LD50 for mice: 400-500 mg/kg (GESTIS (Accessed Sept. 2018))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" (Category 5 in UN GHS classification). [Evidence Data] (1) There is a report that in a study in which 4.3 mL/kg (approximately 4,160 mg/kg (specific gravity: 0.968)) of this substance was dermally applied to rabbits, 3 of 6 animals (2/3 males and 1/3 female) died, and the LD50 is estimated to be about 4,160 mg/kg (Hazard Assessment Report (CERI, NITE, 2009)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. Besides, as for (3), since the application time is long, it cannot be used for classification judgment. [Evidence Data] (1) In a patch test in which 0.2 mL of a 25% solution of this substance was applied occlusively to the skin of 14 human volunteers for 4 hours, a positive reaction was observed in 5/14 subjects, and the substance was determined to be slightly irritating to the skin (Hazard Assessment Report (CERI, NITE, 2009)). (2) 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 a 24-26% solution of this substance, at 14 days, edema was observed in one animal, but the mean score for erythema of 24, 48 and 72-hour readings was 3.0, and the mean score for edema was 1.9 (SCCS (2010)). [Reference Data, etc.] (3) There is a report that slight to severe skin primary irritation was observed in correlation with the applied concentration in a test in which 0.1-2.5% solutions of this substance were applied to the skin of male rabbits for 24 hours (Hazard Assessment Report (CERI, NITE, 2009), GESTIS (Accessed Sept. 2018)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1)-(5), it was classified in Category 1. Besides, the category was changed by use of new information sources. Other than these, although there are also the data in (6), the degree of irritation is unknown and cannot be used for classification judgment. [Evidence Data] (1) There is a report that in an eye irritation test (OECD TG405, GLP-compliant, n=3) with male rabbits, as a result of application of 0.1 mL of a 24-26% solution of this substance, corneal opacity, conjunctival redness, and conjunctival edema were observed for 21 consecutive days. The mean scores at 24, 48, and 72 hours were 2.8, 2.4, and 4.0, respectively (SCCS (2010)). (2) There is a report that in an eye irritation test (OECD TG405, n=3) with rabbits, as a result of application of 0.1 mL of a 28-30% solution of this substance, corneal opacity and conjunctival edema were observed after 7, 14, and 21 days, and iritis was continuously observed for 7 days. The mean scores at 24, 48, and 72 hours were 1.9, 3.7, and 2.3, respectively (SCCS (2010)). (3) In a Draize test (n=6) with rabbits, 0.1 mL of a 2.5% solution of this substance was instilled in the eyes, and the irritation scores for the eyes were rated at 3 hours after application, and between the next day and 35 days. As a result, against a perfect score of 110 points, it showed 60.3 points 3 hours after application, and a mean score of between 1 day and 35 days after application showed 93.0 points. Therefore, it was determined to be severely irritating (Hazard Assessment Report (CERI, NITE, 2009)). (4) There is a report that when 0.1-2.5% solutions of this substance were instilled in the eyes of male rabbits (n=6/group), slight to severe eye irritation was observed in correlation with the applied concentration (Hazard Assessment Report (CERI, NITE, 2009)). (5) This substance is judged to be strongly irritating to the eyes from the combination of the animal test results and in vitro test results (GESTIS (Accessed Sept. 2018)). [Reference Data, etc.] (6) There is a description that the vapor and liquid of this substance show eye irritation in humans (HSDB (2003)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] While there is (4) which shows a false positive result, (1)-(3) show negative results. Therefore, it was classified as "Not classified." [Evidence Data] (1) There is a report that when a 0.25% solution of this substance was applied to the skin of 114 human volunteers for 24 hours/time, 3 times/week for 3 weeks for induction, and a 0.25% solution was reapplied after 17 days, there was no evidence of skin sensitisation, although positive reactions were seen in several subjects (Hazard Assessment Report (CERI, NITE, 2009), GESTIS(Accessed Sept. 2018)). (2) There is a report that in a Maximisation test (OECD TG406, GLP-compliant) with guinea pigs, in which induction was done by application of a 0.125% solution of this substance on the first day followed by 48-hour dermal application of a 3% solution 1 week later, and a challenge conducted with a 0.5% solution on the 21st day, no positive reaction was shown (SCCS (2010)). (3) There is a report that in a Buehler test (OECD TG406, GLP-compliant) with guinea pigs, in which a 4% solution of this substance was applied 3 times for 6 hours/time on days 1, 8 and 15 for induction, and a 1% solution was reapplied at Day 29, no positive reaction was shown (REACH registration dossier (Accessed Sept. 2018), SCCS (2010)). [Reference Data, etc.] (4) In an LLNA test with mice, when 3.5, 8.8 and 17.5% solutions of this substance were applied once a day for 3 days, the stimulation index (SI) were 3.0, 3.0 and 1.1, respectively. However, since no dose-response relationship was observed and cut-off values (3.0) were shown at low and mid doses, it was judged to be a false positive (Hazard Assessment Report (CERI, NITE, 2009)).
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, the results of bacterial reverse mutation tests and mammalian cell chromosomal aberration tests were all negative (Hazard Assessment Report (CERI, NITE, 2009)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to (1) and (2), it is reported that no developmental effect was observed in dermal application tests with rabbits. In addition, there is no study on fertility. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It is reported that in a developmental toxicity test in which 0.5-2.0% solutions of this substance were dermally applied at 2 mL/kg/day during the organogenesis period (gestational Day 7-18) of pregnant rabbits, 1-2 animals died in the control group, 1.0 or 2.0% administration groups, and surviving maternal animals showed dose-related skin irritation findings but no systemic effects, and no effect was observed in fetuses (Hazard Assessment Report (CERI, NITE, 2009)). (2) There is a report that in a developmental toxicity test with pregnant rabbits dermally applied, neither fetotoxicity nor teratogenicity were observed at administration doses up to 40 mg/kg/day (GESTIS (Accessed Sept. 2018)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3 (respiratory tract irritation). Besides, according to (2), effects on the lungs were observed. However, since these are effects at doses exceeding the range of Category 2, it was not used for classification. [Evidence Data] (1) There is a description that the vapor of this substance is irritating to the human throat (HSDB (2003)). [Reference Data, etc.] (2) There are descriptions that in a study in which 4.3 mL of this substance (about 4,160 mg/kg (specific gravity: 0.968)) was applied occlusively to the skin of rabbits for 24 hours, skin irritation symptoms became strong after 24 hours, and 3 of 6 animals died between 5 and 13 days after the application, and that in necropsy of the dead animals, a brown fluid around the nose and mouth, adhesion between the chest wall and lungs, and whitening of the lung were observed (Hazard Assessment Report (CERI, NITE, 2009), GESTIS (Accessed Sept. 2018)). (3) There is a description that in a test in which mice were given a single oral dose of a 4.8% solution of this substance, at 400-500 mg/kg in the vicinity of LD50, symptoms of severe nervous system toxicity (severe ataxia, hyporeflexia) were observed before death. However, as a result of necropsy of dead animals, severe irritation findings were observed in the gastrointestinal tract, and it is considered that deaths were not caused by neurotoxicity of the nervous system but by mucosal irritation (Hazard Assessment Report (CERI, NITE, 2009), GESTIS (Accessed Sept. 2018)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] No information is available on the effects of repeated exposure to humans. In addition, there are no repeated dose toxicity test reports other than (1), and there is no available information for this hazard class. Therefore, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) As for experimental animals, in a test in which 10 mg/kg/day of this substance was dermally applied to the abraded skin of rabbits for 4 weeks, skin irritation symptoms were observed in all the animals, and also histopathologically, slight to moderate acanthosis, keratinization of the skin, exudate, and necrosis of the epidermis and hair follicles were observed, but no signs of systemic effects were observed (Hazard Assessment Report (CERI, NITE, 2009), GESTIS (Accessed Sept. 2018)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour LC50 = 0.01 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2009)).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Chronic toxicity data were not obtained. Because it is not rapidly degradable, and it was classified in Category 1 in acute toxicity, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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