Chlorodifluoromethane

Toxicity to reproduction

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

Constituent 1

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.