Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-201-8
CAS number: 79-38-9
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
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.
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..
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Damit Sie die Website optimal nutzen können, verwenden wir Cookies.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again