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EC number: 200-893-9 | CAS number: 75-71-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 656.6 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8 283.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation to inhalation
- AF for dose response relationship:
- 1
- Justification:
- NOAEC available
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling per REACH R.8.4.3.1 (inhalation)
- AF for other interspecies differences:
- 1
- Justification:
- Mechanistic and comparative metabolism data show that humans likely to be less sensitive to the effects of CFC-12 than rats and mice and are unlikely to be more sensitive.
- AF for intraspecies differences:
- 5
- Justification:
- A default assesment factor for workers, as proposed in the REACH Guidance (R 8.4.3.1)
- AF for the quality of the whole database:
- 1
- Justification:
- General assignment, long term studies available.
- AF for remaining uncertainties:
- 1
- Justification:
- Route to route extrapolation; Inhalation to inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Workers
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.8.4.3.1), no acute/short term exposure DNELs need to be derived.
A NOAEC can be derived for carcinogenic effects in the 2 year study in rats and mice since no effects were observed in the study. A DNEL for CFC-12 can be derived using the NOAEC:5000 ppm = 2.4726e+4 mg/m3 in the rat as the starting point and using the default approach proposed in the ECHA Guidance.
Calculation of DNEL for long-term exposure - carcinogenic / systemic effects in workers is derived as follows:
Description | Value | Remark |
Relevant dose descriptor | Corrected NOAEC 8283.2 mg/m3 (1675.0 ppm) | NOAEC:5000 ppm = 2.4726e+4 mg/m3 Correct for respiratory volume (from resting rat to active human): 6.7 m3/10m3 = 0.67. Correct for exposure time (from 4 hour rat to 8 hour human): 4/8 = 0.5 Corrected NOAEC =2.4726e+4 x 0.67 x 0.5 = 8283.2 mg/m3 (1675.0 ppm) |
Route to route extrapolation | 1 | Inhalation to inhalation |
Scaling factor animal to man | 1 | No allometric scaling per REACH R.8.4.3.1 (inhalation) |
Other interspecies differences | 1 | Mechanistic and comparative metabolism data show that humans likely to be less sensitive to the effects of CFC-12 than rats and mice and are unlikely to be more sensitive. |
Intraspecies variability | 5 | A default assesment factor for workers, as proposed in the REACH Guidance (R 8.4.3.1) |
Exposure duration | 1 | Chronic to chronic |
Dose response | 1 | NOAEL available |
Quality of the database | 1 | General assignment, long term studies available. |
DNEL | Value | |
For workers | 8283.2 / (1 x 1 x 1 x 5 x 1 x 1 x 1) =1656.6 mg/m3 = 334.97 ppm |
The worker 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.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 420.34 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4 203.42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation to inhalation.
- AF for dose response relationship:
- 1
- Justification:
- NOAEC available
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling per REACH R.8.4.3.1 (inhalation)
- AF for other interspecies differences:
- 1
- Justification:
- Mechanistic and comparative metabolism studies show that humans likely to be less sensitive to the effects of CFC-12 than rats and mice and are unlikely to be more sensitive.
- AF for intraspecies differences:
- 10
- Justification:
- A default assesment factor for the general population, as proposed in the REACH Guidance (R 8.4.3.1)
- AF for the quality of the whole database:
- 1
- Justification:
- General assignment, long term studies available.
- AF for remaining uncertainties:
- 1
- Justification:
- Route to route extrapolation; Inhalation to inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General population
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.8.4.3.1), no acute/short term exposure DNELs need to be derived.
It should be noted that CFC-12 is not available to the general population, due to its ban in accordance with the Montreal Protocol. It is no longer used as a propellant in aerosols, and hence exposure is not relevant. However, this data is included for completeness purposes.
A NOAEC can be derived for carcinogenic effects in the 2 year study in rats and mice since no effects were observed in the study. A DNEL for CFC-12 can be derived using the NOAEC:5000 ppm = 2.4726e+4 mg/m3 in the rat as the starting point and using the default approach proposed in the ECHA Guidance.
Calculation of DNEL for long-term exposure - carcinogenic / systemic effects in the general population is derived as follows:
Description | Value | Remark |
Relevant dose descriptor | Corrected NOAEC 4203.42 mg/m3 (850 ppm) | NOAEC:5000 ppm = 2.4726e+4 mg/m3 Correct for exposure time (from 4 hour rat to 24 hour human): 4/24 = 0.17.(ECHA Guidance Chapter R.8 (fig. R.8-2)). Corrected LOAEL =2.4726e+4x 0.17 = 4203.42 mg/m3 (850 ppm) |
Route to route extrapolation | 1 | Inhalation to inhalation |
Scaling factor animal to man | 1 | No allometric scaling per REACH R.8.4.3.1 (inhalation) |
Other interspecies differences | 1 | Mechanistic and comparative metabolism studies show Mechanistic and comparative metabolism studies show that humans likely to be less sensitive to the effects of CFC-12 than rats and mice and are unlikely to be more sensitive. |
Intraspecies variability | 10 | A default assessment factor for the general population, as proposed in the REACH Guidance (R 8.4.3.1) |
Exposure duration | 1 | Chronic to chronic |
Dose response | 1 | NOAEL available |
Quality of the database | 1 | General assignment, long term studies available. |
DNEL | Value | |
For general population | 4203.42/ (1 x 1 x 1 x 10 x 1 x 1 x 1) =420.34 mg/m3 = 84.90 ppm |
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