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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The NOAEL for repeated dose toxicity is higher than 41000 mg/m3 in rats exposed for a period of 3 months and higher than 82000 mg/m3 in rats exposed for a period of 2 years.

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
82 000 mg/m³

Additional information

In accordance with section 2 of REACH Annex XI, studies via the oral and dermal route do not need to be conducted as the substance is a gas.

 

In the 90-day near-guideline inhalation study with rats, exposed via whole body to 1000 and 10000 ppm 1-chloro-1,1-difluoroethane for 6 hours/day, 5 days/week for 13 weeks, no treatment-related effects upon mortality, body weight, hematology, clinical chemistry, urinalysis or histopathological evaluation of selected tissues were observed. No target organs were identified. A NOAEL of 10000 ppm (41000 mg/m3) was established. The same results were obtained with dogs exposed by the same procedure.

 

In a combined chronic toxicity/carcinogenicity study conducted by Bio/dynamiacs Inc., rats were exposed for 2 years for 6 hous/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. Non-neoplastic microscopic pathology findings at final sacrifices were similar in treated and control groups and were confined to degenerative lesions typical of old rats of the strain used in the study.

 

Overall the NOAEL for repeated dose toxicity is higher than 41000 mg/m3 in rats exposed for a period of 3 months and higher than 82000 mg/m3 in rats exposed for a period of 2 years.

Justification for classification or non-classification

Based on the NOAEL of 41000 mg/m3 in a 90-days subchronic toxicity study with rats and the NOAEL of 82000 mg/m3 in a two years study with rats, classification of 1 -chloro-1,1 -difluoroethane for repeated dose toxicity 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.