Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Short description of key information:
No toxicity concern was found for fertility in the existing repeated dose toxicity studies and in a prenatal developmental toxicity test. Therefore based on REACH, a two generation test does not need to be conducted.

Effects on developmental toxicity

Description of key information
There was no evidence for developmental abnormalities at any level. Decreased body weight gain and food consumption was reported for the dams exposed to 90 and 180 ppm of CTFE. Decreased fetal weight and delayed ossification was seen in pups from dams exposed to 180 ppm. Based on these, the NOAEC for developmental toxicity was considered as 90 ppmV. However, even at the highest concentration 180 ppm, there was no evidence for developmental abnormalities.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
428.72 mg/m³
Additional information

A prenatal toxicity test (Gary M. Hoffman, B.A. 2005) was conducted according to OECD test guideline 414, which was compliant with GLP. In the test, groups of 25 time-mated female rats were exposed once daily for 6 hours/day, 7 days/week during gestation days 6-19 and euthanized and necropsied on gestation day 20. Exposure levels were monitored using an on-line IR sampling procedure. Exposure at 180 ppm resulted in significant body weight loss in the dams. As a consequence, exposure to this group was terminated prior to the final scheduled exposure. However the rats were evaluated at the end of the gestation period along with the rats from the other groups. There was no evidence for developmental abnormalities at any level. Decreased body weight gain and food consumption was reported for the dams exposed to 90 and 180 ppm of CTFE. There was also slight reduction in the state of ossification of the fetal skeleton at the 180 ppm exposure level, but for the sporadic incidences of other fetal variants and abnormalities there was no indication of association with test substance exposure.

Based on above results, exposure at 30 ppm was considered as the no-observed-adverse-effect-level ((NOAEL) for maternal toxicity, exposure at 90 ppm as NOAEL for developmental toxicity, and 180 ppm as NOAEL for teratogenicity. The key value was selected as 90 ppm for developmental toxicity corresponding to 428.72 mg/m3in air at 25°C and 760 Torr..

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Justification for classification or non-classification

There was no evidence for developmental abnormalities at any level set in the test. Furthermore no toxic concern for fertility was found in repeated dose toxicity test, neither in the prenatal toxicity test. Therefore CTFE dose not meet any criteria for reproductive toxicity classification under Regulation (EC) No 1272/2008.