GHS Classification Result

Chemical Name：Benzethonium chloride
CAS：121-54-0

Result：
ID: 22A4103
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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.
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 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".
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		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.
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.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		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.
3 Serious eye damage/eye irritation Category 2 Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection. 		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.
4 Respiratory sensitization Classification not possible - - - - No data available.
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)).
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.
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.
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".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 96h-LC50 = 1.4 mg/L for fish (Lepomis macrochirus) (AQUIRE, 2011; HSDB, 2010).
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		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)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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