Registration Dossier
Registration Dossier
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EC number: 200-893-9 | CAS number: 75-71-8
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Fluorocarbons in question
- Author:
- Paulet G.
- Year:
- 1 976
- Bibliographic source:
- European journal of toxicology and environmental hygiene. Journal europeen de toxicology. 9(7 Suppl):385-407
- Reference Type:
- review article or handbook
- Title:
- Toxicity of selected drinking water contaminants
- Author:
- Safe Drinking Water Committee
- Year:
- 1 989
- Bibliographic source:
- National Research Council. Drinking Water and Health. Volume 3. Washington, DC: National Academy Press, 1989.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Summary only.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Dichlorodifluoromethane
- EC Number:
- 200-893-9
- EC Name:
- Dichlorodifluoromethane
- Cas Number:
- 75-71-8
- Molecular formula:
- CCl2F2
- IUPAC Name:
- dichlorodifluoromethane
- Test material form:
- not specified
- Details on test material:
- Dichlorodifluoromethane (CFC-12) is a relatively inert, non-flammable liquid that is used mainly as a refrigerant. Its molecular weight is 120.92, its vapor pressure is 6.43 atm at 25°C, and it is quite insoluble in water (5.7 ml/100 ml at 26°C).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- pregnant females
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- air
- Details on exposure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Animals inseminated
- Duration of treatment / exposure:
- Rats: gestation day 4 to 16
- Frequency of treatment:
- 2 hours per day.
- Duration of test:
- Half of the Rats were sacrificed on day 20 of gestation, the rest were allowed to deliver
Doses / concentrations
- Dose / conc.:
- 200 000 ppm (nominal)
- Remarks:
- eq. to 20% concentration of a mixture of CFC-11 (10%) and CFC-12 (90%) in air
(i.e., approx. 180000 ppm CFC-12)
- No. of animals per sex per dose:
- 20 female rats
- Control animals:
- not specified
- Details on study design:
- Inseminated Wistar albino rats were administered a mixture of 90% CFC-12 (dichlorodifluoromethane) and 10% Freon 11 by inhalation for 2hr/day. Pregnant rats were exposed on days 4 to 16 of gestation. The mixture was administered in a 20% concentration (200,000 ppm).
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: no data
BODY WEIGHT: Yes
- Ovaries and uterine content:
- Not specified
- Fetal examinations:
- Yes, but no details provided
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects: no effects
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- > 200 000 ppm (nominal)
- Based on:
- test mat.
- Remarks:
- (mixture of 10% CFC-11 and 90% CFC-12)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- No effects on survival at birth
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- Description (incidence and severity):
- No effects on survival after 1 and 4 weeks
- External malformations:
- no effects observed
- Description (incidence and severity):
- No details on examinations performed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects reported.
Limited details available on teratogenicity examination.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- >= 200 000 ppm
- Based on:
- test mat.
- Basis for effect level:
- other: No embryotoxicity or fetotoxicity observed at that concentration
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- (limited details available)
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
No indications of any embryotoxic, fetotoxic, or teratogenic changes were found when dams were sacrificed and foetuses removed on day 20 of gestation (rats).
Applicant's summary and conclusion
- Conclusions:
- No indications of any embryotoxic, fetotoxic, or teratogenic changes were found in the offspring of rats exposed during gestation days 4 to 16.
- Executive summary:
In studies of inseminated Wistar albino rats, Paulet et al. (1974) administered a mixture of 90% CFC-12 (dichlorodifluoromethane) and 10% Freon 11 by inhalation for 2hr/day. Rats were exposed on days 4 to 16 of gestation. The mixture was administered in a 20% concentration (200,000 ppm). No indications of any embryotoxic, fetotoxic, or teratogenic changes were found when dams were sacrificed and foetuses removed on day 20 of gestation (rats). No classification is applicable.
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