Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Carcinogenicity

A 2-year chronic oral feeding study was conducted using albino rats. Benzethonium Chloride was mixed in the diet to give concentrations of 0, 50, 200, 1000, 2500, and 5000 ppm. One group of 10 males and one of 10 females were fed each dietary concentration. Rats that died and those killed at termination were necropsied and tissues were examined microscopically. Three mammary gland fibroadenomas were found; none occurred in the 2 highest dose groups. The investigators commented that this tumor occurrence of 6.5 percent was low for rats of that age. One subcutaneous reticulum cell sarcoma was found in a male of the 200 ppm group after 53 weeks, but the occurrence of this tumor was unrelated to treatment because no such tumors were found in higher dose groups over a longer period of time. No evidence of carcinogenicity of Benzethonium Chloride was found in further studies with mice and rats.

Source:

CIR-Report (Lit: Journal of the American College of Toxicology, Volume 4, Number 5, 1985, Mary Ann Liebert, Inc., Publishers)

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

According to the GHS criteria, the test item does not require classification as carcinogenic.

Additional information