NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	121-54-0
Chemical Name	Benzethonium chloride
Substance ID	m-nite-121-54-0_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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified	- -	-	-	Although the substance is an organic compound containing chlorine and oxygen, this chlorine does not have oxidizing property for its ionic bonds to quaternary amine. The substance was classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the five LD50 values for rats of 368 - 665 mg/kg (NTP TR 438 (1995)), 368, 420 plus or minus 20, 450 and 665 mg/kg (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol. 4, No. 5, (1985)), the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	The mouse LD50 value of > 280 mg/kg was reported (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol. 4, No. 5 (1985)). Since this value did not provide the basis for classification, the classification was not possible.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In the rabbit test, application of 2 mL (0.1% solution) of the test substance to the skin caused no irritation. And in the mouse test, single application of 35 - 280 mg/kg to skin caused no irritation in low dose, but caused severe local reaction with blisters (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 4, Number 5 (1985)). In the human case of 100 volunteers, occlusive application of 5% aqueous solution for 48 hours caused erythema with neither blister nor permeation, but symptoms were all reversible after 24 hours of patch removal (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 4, Number 5 (1985)). It was concluded that the substance may cause irritation to skin by more than 5%. Thus, the substance was classified as Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In the rabbit test, there were some description that the threshold of irritation was more than 0.03%, that the substance actually had irritation effect, and that maximum tolerated dose that neither conjunctival nor iris injury caused after 7 days of application was 0.1 mL of 0.5% solution (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol.4, No. 5 (1985)). Based on this document, the substance was classified as Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, 12 in 42 people treated with the mixture containing benzethonium chloride revealed sensitization (Acta Otolaryngol. 100: 414 (1985)). One case report that worker who handled benzethonium chloride showed sensitization, and two other case reports that persons who used hygiene spray containing benzethonium chloride showed sensitization, were reported (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol. 4, No. 5 (1985)). In addition, in the sensitization test (repeated insult patch test), treatment of the detergent containing 0.5% of this substance to 100 subjects caused slight skin reactions in 7 subjects after induction. And after elicitation, skin reaction was observed in 6 subjects. As a result of re-elicitation to 3 of these 6 subjects, one showed slight reaction according to the abrasive character of the detergent. Thus, it was concluded that the substance was slightly irritable, but did not have the sensitization potential (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol. 4, No. 5 (1985)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro mutagenicity tests, negative results in the Ames test (NTP DB (Access on Oct. 2010), JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol. 4, No. 5, (1985)) and the chromosome aberration test using CHO cells (NTP DB (Access on Oct. 2010)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, in the 2-year dermal application test using rats and mice, no evidence of carcinogenicity in both animal species was concluded (NTP TR438 (1995)). No data other than dermal application test were obtained, therefore, the classification was concluded as "Classification not possible". As old information, in the 2-year dietary administration test using rats in 1954, no tumors in relation to the dosing were found, however, a small number of animals (10 animals/dose group/sex) were used, so that no detailed data were known.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the oral administration study using pregnant rats during the organogenetic period, increased incidences of delayed ossification in fetuses were observed at doses at which decreased weight gain was observed in maternal animals, however, no adverse effects on the development of offspring were reported (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY vol. 4, No. 5 (1985)). However, since no information was provided regarding sexual functions and fertility of parental animals, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 2-year feeding study in rats, marked dilatation of the cecum was found in the dose groups at 1000 ppm (converted value as the actual intake: 50 mg/kg/day) or higher, and thinning of cecum wall was revealed histologically (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 4, Number 5 (1985)). With regard to the findings in the cecum, there were no related changes and no other abnormalities, and no reports other than this result existed even extending to that of the other animal species. Thus, the change was not adopted as the basis of classification due to the unclearness of toxicological significance. Meanwhile, no abnormalities were found up to the highest dose level of 500 ppm (13 mg/kg/day) in the 1-year feeding study in dogs (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 4, Number 5 (1985)), and no systemic effects except for suppression of body weight gain were noted in the 13-week dermal toxicity studies in rats and mice (NTP TR 438 (1995)). The doses examined in all of these studies were lower values within the guidance values. Overall, as a conclusion, "Classification not possible" was adopted due to lack of sufficient data.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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	Classified into Category 2 from its 96h-LC50 = 1.4 mg/L for fish (Lepomis macrochirus) (AQUIRE, 2011; HSDB, 2010).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Classified into Category 2 since its acute toxicity is Category 2 and the bioaccumulation potential is estimated to be high (Log Kow = 4.0 (PHYSPROP Database, 2011)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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