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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	68424-85-1
Chemical Name	Alkyl(C=12-16)(benzyl)(dimethyl)ammonium chloride
Substance ID	R02-A-095-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (MOLBASE Encyclopedia (Accessed Dec. 2020)).
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.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen), which is chemically bonded to the element other than carbon or hydrogen (N). However, because this is an ionic bond and does not contribute to oxidization, it was classified as "Not classified."
15	Organic peroxides	Not classified (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.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] it was classified in Category 3 from (1). [Evidence Data] (1) LD50 for rats: about 304.5 mg/kg (males: about 510.9 mg/kg, females: about 280.8 mg/kg) (EPA Pesticides RED (2006))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1), (2). [Evidence Data] (1) LD50 for rats: about 930 mg/kg (males: about 1100 mg/kg, females: about 704 mg/kg) (EPA Pesticides RED (2006)) (2) LD50 for rats: about 2,848 mg/kg (AICIS (formerly, NICNAS IMAP) (2015))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
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)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1). [Evidence Data] (1) LC50 for rats (4 hours): between 0.054-0.51 mg/L (EPA Pesticides RED (2006))
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1), (2). [Evidence Data] (1) It was corrosive in a skin irritation test with rabbits (EPA Pesticides RED (2006), Regul. Toxicol. Pharmacol., 116 (2020)). (2) It is reported that in a skin irritation test with rabbits (n = 6) (occlusive, 24-hour application, 72-hour observation), as a result of applying this substance to the abraded skin and intact skin, severe erythema and edema were observed, and the primary dermal irritation index (PDII) was calculated as 6.29 (REACH registration dossier (Accessed Dec. 2020), Regul. Toxicol. Pharmacol., 116 (2020)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1). [Evidence Data] (1) It was classified in Category 1 in skin corrosion/irritation.
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] It was classified as "Not classified" from (1). [Evidence Data] (1) This substance is not a skin sensitizer (EPA Pesticides RED (2006), Regul. Toxicol. Pharmacol., 116 (2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a chromosomal aberration test using the bone marrow cells of mice (dosed once by gavage, purity: 80%), negative results were reported (Regul. Toxicol. Pharmacol., 116 (2020)). (2) In a bacterial reverse mutation test (OECD TG 471, purity: 49.2%), negative results were reported (Regul. Toxicol. Pharmacol., 116 (2020)). (3) In an in vitro mammalian cell gene mutation test (purity: 80%), negative results were reported (Regul. Toxicol. Pharmacol., 116 (2020)). (4) In a chromosomal aberration test using the human lymphocytes (OECD TG 473, purity: 49.2%), negative results were reported (Regul. Toxicol. Pharmacol., 116 (2020)). [Reference Data, etc.] (5) The database for mutagenicity of this substance was considered sufficient, and based on that, this substance was not considered to be mutagenic or genotoxic (EPA Pesticides RED (2006)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, the EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report (2019): Classification in 1999). (2) In a two-year carcinogenicity study for this substance (C12-C16 ADBAC) of high purity (purity: 81%) and low purity (purity 50%) with rats (OECD TG 453), no evidence of carcinogenicity was observed up to the highest dose at which reductions in body weight and food consumption were observed (Regul. Toxicol. Pharmacol. (2020)). (3) In a 78-week carcinogenicity study for this substance of high purity (purity: 81%) with mice, no evidence of carcinogenicity was observed up to the highest dose at which a decrease in body weight was observed (Regul. Toxicol. Pharmacol. (2020)). [Reference Data, etc.] (4) Based on the studies with rats and mice, it was concluded that this substance was not carcinogenic (EPA Pesticides RED (2006)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (from 10 weeks before mating until weaning of F2), no effect on fertility was observed in parental animals and only lower body weight was observed in F1 and F2 pups (Regul. Toxicol. Pharmacol. 166 (2020)). (2) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (OECD TG 416, from 10 weeks before mating of F0 until weaning of F2), at doses at which general toxicity effects (reduced body weight gain, a reduction in food consumption, a decrease in liver weight, dilation of the cecum or colon) were observed in parental animals, only a decrease in spleen weight, lower body weight, reduced body weight gain, and dilation of the cecum (only F2) were observed in F1 and F2 pups (Regul. Toxicol. Pharmacol. 166 (2020)). (3) It was reported that in a developmental toxicity study with rats dosed by gavage (days 6-15 of gestation), no developmental toxicity was observed (Regul. Toxicol. Pharmacol. 166 (2020)). (4) It was reported that in a developmental toxicity study with rabbits dosed by gavage (days 6-18 of gestation), no developmental toxicity was observed (Regul. Toxicol. Pharmacol. 166 (2020)). (5) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG 414, days 6-28 of gestation), no developmental toxicity was observed (Regul. Toxicol. Pharmacol. 166 (2020)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) It was reported that in a 13-week oral toxicity study with rats dosed by feeding (OECD TG408), liver effects (decreases in absolute and relative liver weight) (males), and decreases in white blood cell count, lymphocytes, and monocytes (females) were observed at 5,000 ppm (166 mg/kg/day (males), 188 mg/kg/day (females), in the range corresponding to "Not classified") (Regul. Toxicol. Pharmacol., 116 (2020)). (2) It was reported that in a 13-week oral toxicity study with rats dosed by feeding, a trend toward decreased food consumption and body weight was observed at 1,000 ppm (62 mg/kg/day (males), 77 mg/kg/day(females), within the range for Category 2); and congestion and edema of the gastrointestinal tract and hemorrhaging in the brain and lungs were observed at 4,000 ppm (200 mg/kg/day (males), 200 mg/kg/day (females), in the range corresponding to "Not classified") (Regul. Toxicol. Pharmacol., 116 (2020)). (3) It was reported that in a 13-week oral toxicity study with mice dosed by feeding, a reduction in body weight was observed at 1,000 ppm (174 mg/kg/day (males), 210 mg/kg/day (females), in the range corresponding to "Not classified") (Regul. Toxicol. Pharmacol., 116 (2020)). (4) It was reported that in a 78-week oral toxicity study with mice dosed by feeding, reductions in body weight and body weight gain were observed at 1,500 ppm (229 mg/kg/day (males), 289 mg/kg/day (females), in the range corresponding to "Not classified") (Regul. Toxicol. Pharmacol., 116 (2020)). [Reference Data, etc.] (5) It was reported that in a 13-week dermal toxicity study with rats, slight hyperkeratosis was observed at 2 mg/kg/day (within the range for Category 1) (Regul. Toxicol. Pharmacol., 116 (2020)). (6) It was reported that in a 21-day dermal toxicity study with guinea pigs, slight reductions in body weight and food consumption were observed at 40 mg/kg/day (converted guidance value: 9.33 mg/kg/day, within the range for Category 1) (Regul. Toxicol. Pharmacol., 116 (2020)).
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 Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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