Registration Dossier

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study details not reported
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Principles of method if other than guideline:
not reported
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorodifluoromethane
EC Number:
200-871-9
EC Name:
Chlorodifluoromethane
Cas Number:
75-45-6
Molecular formula:
CHClF2
IUPAC Name:
chlorodifluoromethane
Details on test material:
not reported

Test animals

Species:
rat
Strain:
other: Charles River Rats
Sex:
female
Details on test animals or test system and environmental conditions:
not reported

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure (if applicable):
not specified
Vehicle:
air
Details on exposure:
not reported
Details on mating procedure:
not reported
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not reported
Duration of treatment / exposure:
days 6-15 of gestation
Frequency of treatment:
daily
Details on study schedule:
not available
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.05, 0.10, 2.00%
Basis:
nominal conc.
No. of animals per sex per dose:
40
Details on study design:
not available
Positive control:
not reported

Examinations

Parental animals: Observations and examinations:
not reported
Oestrous cyclicity (parental animals):
not reported
Sperm parameters (parental animals):
not reported
Litter observations:
not reported
Postmortem examinations (parental animals):
not reported
Postmortem examinations (offspring):
not reported
Statistics:
not reported
Reproductive indices:
not reported
Offspring viability indices:
not reported

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed

Details on results (P0)

No clinical signs of toxicity were observed in maternal animals. The number of implantations, early and late
resorptions, and number of live fetuses per litter were unaffected.

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Histopathological findings:
effects observed, treatment-related
Description (incidence and severity):
poradic appearance of major malformations of the eye

Details on results (F1)

There was a sporadic appearance of major malformations of the eye in all test groups. The increased incidence of eye defects was not statistically significant. Authors believe that the test substance may have interacted with the genetic make-up of affected fetuses and caused the increased expressivity of a mutant gene. The authors considered the test substance to be a mutagen under the conditions of this study.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

not available

Applicant's summary and conclusion

Conclusions:
No clinical signs of toxicity were observed in maternal animals. The number of implantations, early and late resorptions, and number of live fetuses per litter were unaffected. There was a sporadic appearance of major malformations of the eye in all test groups. The increased incidence of eye defects was not statistically significant. Authors believe that the test substance may have interacted with the genetic make-up of affected fetuses and caused the increased expressivity of a mutant gene. The authors considered the test substance to be a mutagen under the conditions of this study.
Executive summary:
In a one generation study 40 female Charles river rats were exposed to nominal concentrations of 0, 0.05, 0.10, 2.00%. No clinical signs of toxicity were observed in maternal animals. The number of implantations, early and late resorptions, and number of live fetuses per litter were unaffected. There was a sporadic appearance of major malformations of the eye in all test groups. The increased incidence of eye defects was not statistically significant.