1,1,1-trifluoroethane

Genetic toxicity: in vivo

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

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 483 (Mammalian Spermatogonial Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

rodent dominant lethal assay

Test material

Test material information

Constituent 1

Reference substance name:

Norflurane

EC Number:

212-377-0

EC Name:

Norflurane

Cas Number:

811-97-2

Molecular formula:

C2H2F4

IUPAC Name:

1,1,1,2-tetrafluoroethane

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

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

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.