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Toxicological information

Developmental toxicity / teratogenicity

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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:
1976
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:
1989
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

Constituent 1
Chemical structure
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).

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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