Registration Dossier
Registration Dossier
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EC number: 201-201-8 | CAS number: 79-38-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.77 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 138.14 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 69.42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA REACH Guidance R.8. methodology, the dose descriptor starting point (NOAEC, rat) is corrected for taking into account:
- Differences in human and experimental exposure conditions (8 hours/day exposure for workers vs 6 hours/day exposure for rat).
- Differences in respiratory volumes between experimental animals (at rest) and workers (light activity)
Corrected NAEC (human) = 138.14 mg/m3 (NOAEC rat) x 6.7 m 3 / 10 m 3 x 6 (h/d) / 8 (h/d) = 69.42 mg/m3
Where:
6.7 m3: respiratory volume during no physical activity
10 m3: respiratory volume during light physical activity
6 h/day: exposure duration rat
8 h/day: exposure duration workers
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEC / Data support the confidence in the dose descriptor.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC was derived from a sub-chronic test. Default AF according to REACH guidance R.8.4.3.1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since the adjusted starting point was in mg/m3
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to REACH guidance R.8.4.3.1
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers according to REACH guidance R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- CTFE was tested by inhalation for subacute and subchronic toxicity in several studies and on several species.
The selected key study was valid and reliable. Results of the key study are supported by consistent findings observed in other subacute and subchronic studies conducted on rat. - AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 65.62 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 485.89 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 820.31 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA REACH Guidance R.8. methodology, the dose descriptor starting point (NOAEC, rat) is corrected for taking into account differences in respiratory volumes between experimental animals (at rest) and workers (light activity):
NAEC (4h, human) = 485.89 mg / m3 (NOAEC, 4h rat) x 6.7 m3/ 10 m3= 325.54 mg/m3
Where:
6.7 m3: respiratory volume during no physical activity
10 m3: respiratory volume during light physical activity
The corrected dose descriptor for the exposure duration of 15 minutes is extrapolated from the NAEC (4h, human) by the mean of the modified Haber’s equation (ECHA Guidance R.8). The use of the Haber’s equation is considered valid as the acute toxic effects of CTFE are observed to be dose related. Being no data available for CTFE on concentration-time ratio for exposure time shorted than 3 hour, the modified Haber’s law: Cnx t = k is applied with a default n=3 (ECHA Guidance R.8).
NAEC (15 min, human) = [NAEC (4h, human)3x 4h / 15 min ] 1/3 = [ 325.543x 4 / 0.25 ] 1/3 = 820.31 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEC.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since the adjusted starting point is in mg/m3
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to REACH guidance R.8.4.3.1
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers according to REACH guidance R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- Several acute toxicity studies (K2 or K4) through the inhalation route are available, performed on several species (rat, mouse, guinea pig, rabbit, dog).
The dose descriptor starting point derives form a reliable study (K2) conducted on the preferred species (rat).
Key and supporting studies provide consistent information. - AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.69 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 138.14 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 34.535 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA REACH Guidance R.8. methodology, the dose descriptor starting point (NOAEC, rat) is corrected for taking into account: differences in human and experimental exposure conditions (24 hours/day exposure for general population vs 6 hours/day exposure for rat).
Corrected NAEC (human) = 138.14 mg/m3 (NOAEC rat) x 6 h/d / 24 h/d = 34.535 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEC / Data support the confidence in the dose descriptor.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC was derived from a sub-chronic test. Default AF according to REACH guidance R.8.4.3.1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since the adjusted starting point was in mg/m3
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for workers according to REACH guidance R.8.4.3.1
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for workers according to REACH guidance R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- CTFE was tested by inhalation for subacute and subchronic toxicity in several studies and on several
species.
The selected key study was valid and reliable. Results of the key study are supported by consistent findings observed in other subacute and subchronic studies conducted on rat. - AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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