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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity tests with styrene oxide in mammals.
Author:
Fabry L et al
Year:
1978
Bibliographic source:
Mutat Res. 1978 Sep;51(3):377-81.
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
GLP compliance:
no
Remarks:
study performed before implementation of GLP
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Paraffin oil
Details on exposure:
To test the ability of styrene oxide to induce chromosomal aberrations in male post-meiotic germ cells, each male was caged, after injection, with three virgin females from the same strain which were replaced after 7 and 14 days.
Duration of treatment / exposure:
250 mg/kg bw
Frequency of treatment:
once prior to mating
Doses / concentrations
Remarks:
Doses / Concentrations:
250 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
7 treated animals; 10 control animals
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
The males were then kept for another two months, killed and their dividing spermatocytes examined for the presence of reciprocal translocations induced in the pre-meiotic cells. The females were dissected 17 days after mating had started, and pre- and post-implantation losses were determined by conventional methods.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Styrene oxide did not induce dominant lethal mutations or translocations in meiotic germ cells of male BALB/c mice
Executive summary:

Styrene oxide did not induce dominant lethal mutations or translocations in meiotic germ cells of male BALB/c mice administered styrne oxide by intraperitoneal injection at a dose of 250 mg/kg bw.