Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In the combined chronic toxicity/carcinogenicity study with rats, no neoplastic lesions were found up to concentrations of 20000 ppm (82000 mg/m3).

Key value for chemical safety assessment

Carcinogenicity: via inhalation route

Endpoint conclusion
Dose descriptor:
NOAEC
82 000 mg/m³

Justification for classification or non-classification

Based on the absence of neoplastic lesions in rats exposed to concentrations up to 20000 ppm (82000 mg/m3) for 2 years, classification of 1-chloro-1,1-difluoroethane for carcinogenicity is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information

The carcinogenicity of 1 -chloro-1,1 -difluoroethane was evaluated in the combined chronic toxicity/carcinogenicity study conducted by Bio/dynamiacs Inc. Male and female rats were exposed for 2 years for 6 hours/day, 5 days/week to an atmosphere of 1-chloro-1,1-difluoroethane at concentrations up to 20000 ppm (82000 mg/m3). No treatment-related effects on mortality, body weight, hematology, clinical chemistry, urinalysis and ophtalmological examinations, histopathological evaluation of selected tissues or statistical analysis of neoplasms incidences were found. Neoplastic findings in animals that died during the study or in survivors to termination were similar in control and all exposed groups and compromised predominantly tumours of the mammary and subcutaneous tissues in females and pituitary and adrenal adenomas in both sexes. No treatment-related increases in tumours of the respiratory tract were noted.