Registration Dossier
Registration Dossier
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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:
- 1 657 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):
- 5
- Dose descriptor starting point:
- NOAEC
- Value:
- 24 726 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8 283.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Repeated dose toxicity data are available from 90-day studies and 2-year study in rats. The point of departure is the NOAEC from the 2 years study. Although that study is less complete, results were consistent with those from the 90-day study conducted at a higher concentration. Considering test conditions adjustment the derivation of a DNEL from the 90-day would result in a 2-fold higher value. The lowest derived value was therefore selected.
NOAEC: 5000 ppm = 24726 mg/m3
Correct for respiratory volume (from resting rat to active human): 6.7 m3/10m3 = 0.67.
Adjustment for exposure time (from 4 hour rat to 8 hour human): 4/8 = 0.5
Corrected NOAEC =24726 x 0.67 x 0.5 = 8283.2 mg/m3 (1675.0 ppm)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- study by inhalation route.
- AF for other interspecies differences:
- 1
- Justification:
- Pharmacokinetics studies indicates no metabolisation of the substance, and a rapid elimination of the majority of the substance by exhaled air in both humans and animals.
- AF for intraspecies differences:
- 5
- Justification:
- Default assesment factor for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
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
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.
NOAEC are available from two repeated dose toxicity studies. Considering test conditions adjustment the derivation of a DNEL from the 90-day would result in a 2-fold higher value. The lowest value was therefore selected, using the NOAEC from the 2-year study.
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 a rapid elimination through exhaled air in both humans and animals following exposure, with little or no metabolism. |
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:
- 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
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
There are no allowed uses of the substance by the general population. Following the Montral Protocol the substance is not longer used as a propellant in aerosols.
No exposure of the general population is expected.
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.
