Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

According to Annex XI No. 2 the testing for oral repeated dose toxicity is technically not possible (not feasible): testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance, e.g. high volatibility. The method described by Annex B.26 - Subchronic oral toxicity - is not applicable.

According to Annex XI No. 2 the testing for dermal repeated dose toxicity

is technically not possible (not feasible): testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance, e.g. high volatibility. The method described by Annex B.28 - Subchronic dermal toxicity - is not applicable.

In a test on inhalative repeated dose toxicity eighty male and eighty female Alderley Park Swiss mice per group were exposed to concentrations of 0, (two groups) 1000, 10,000 or 50,000 ppm (0, 3500, 35,000, 175,000 mg/m3) chlorodifluoromethane, 5 hr/d, 5 d/wk for up to 83 weeks (females) and 94 weeks (males). The only consistent finding was hyperactivity in male mice exposed to 50,000 ppm chlorodifluoromethane. No effects were noted on mortality, body weight gain, haematology and biochemistry nor in histopathology. The No Observed Adverse Effect Concentration (NOAEC) for chlorodifluoromethane in this study was 10,000 ppm (35,000 mg/m3).

Justification for classification or non-classification

The testing of chlorodifluoromethane on oral repeated dose toxicity

is technically not feasable, so this endpoint for this classification can not be determined.

The testing of chlorodifluoromethane on dermal repeated dose toxicity

is technically not feasable, so this endpoint for this classification can not be determined.

The testing of chlorodifluoromethane on inhalative repeated dose toxicity with Alderley Park Swiss mice gave as

only consistent findings hyperactivity in male mice exposed to 50,000 ppm chlorodifluoromethane. No effects were noted on mortality, body weight gain, haematology and biochemistry nor in histopathology. So a NOAEC for chlorodifluoromethane in this study was derived as 10,000 ppm (35,000 mg/m3) which gives no reason for classification.