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EC number: 204-126-9
CAS number: 116-14-3
According to the REACH "Guidance on information requirements and
chemical safety assessment" , a leading DN(M)EL needs to be derived for
every relevant human population and every relevant route, duration and
frequency of exposure, if feasible. As the substance is a gas, oral and
dermal routes of exposure are considered to be irrelevant, therefore no
DNELs were derived for these routes. The substance is not classified for
acute toxicity, and according to REACH "Guidance on information
requirements and chemical safety assessment" (R.188.8.131.52), no acute/short
term exposure DNELs need to be derived.
No NOAEL could be derived for carcinogenic effects in the 2 year NTP
study in rats and mice since tumours were observed at the lowest level
of exposure for rats, 156 ppm (638 mg/m3). Whilst TFE is carcinogenic in
both mice and rats, there is no evidence that it has genotoxic
properties. It is concluded, therefore, that the effects are due to a
non-genotoxic mechanism and that risk characterisation can proceed using
a DNEL based on the assumption of a threshold mechanism.
Table A. Calculation of DNEL for long-term exposure - carcinogenic /
systemic effects in workers is derived as follows:
DNEL for workers (based on ECHA Guidance = 6.4 mg/m3 (1.6 ppm)
DNEL value derived for chronic exposure would have to be adapted in case
of a different shift system (= daily exposure time). In that case the
amended DNEL would result in virtually the same value under the
condition that the weekly exposure time would be almost identical.
A DNEL for TFE can be
derived using the LOAEL of 156 ppm (638 mg/m3) for renal tubular
degeneration in the rat as the starting point and using the default
approach proposed in the ECHA Guidance.
Table B. Calculation of DNEL for long-term exposure - carcinogenic /
systemic effects in the general population is derived as follows:
Relevant dose descriptor
Corrected LOAEL 159 mg/m3 (39 ppm)
Correct for exposure time (from 6 hour rat to 24 hour human): 6/24 = 0.25.
Corrected LOAEL = 638 x 0.25 = 159 mg/m3 (39 ppm)
Route to route extrapolation
Inhalation to inhalation
Scaling factor animal to man
No allometric scaling per REACH R.184.108.40.206
Other interspecies differences
Mechanistic and comparative metabolism studies show that humans likely to be less sensitive to the effects of TFE than rats and mice and are unlikely to be more sensitive.
A default assesment factor for the general population, as proposed in the REACH Guidance (R 220.127.116.11)
Chronic to chronic
Quality of the database
No developmental and limited reproductive data
For general population
159 / (1 x 1 x 1 x 10 x 1 x 5 x 2) = 1.59 mg/m3
DNEL for general population (based on ECHA Guidance = 1.59 mg/m3
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.
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