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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

GLP compliance:
yes
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Duration of treatment / exposure:
5 days
Frequency of treatment:
6 hours / day
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 10000, 50000ppm
Basis:

No. of animals per sex per dose:
15 males / 30 females
Control animals:
yes, concurrent no treatment

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Negative controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

In a dominant lethal assay, CD1 male mice were exposed to up to 50000ppm HFC 134a for 5 days. After the last exposure, each male was housed with 2 virgin females for 4 consequetive nights. Further matings with new females were conducted at weekly intervals for a total of 8 times. The study indicated that HFC 134a did not affect male fertility or cause mutagenic effects through sperm.