Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 29 NOV 2012 to 31 JAN 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.39 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells In Vivo)
Deviations:
no
GLP compliance:
yes
Type of assay:
unscheduled DNA synthesis

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
single exposure
Frequency of treatment:
once
Post exposure period:
The animals were examined for acute toxic symptoms at intervals of approx. 1 h, 2 h and 4 h for the 4 hours treatment, and 1 h, and 16 h for the 16 hours treatment after administration of the test item.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 2000 mg/kg b.w.
Basis:
actual ingested
No. of animals per sex per dose:
2 males and 2 females were used in the pre-experiment
32 males were used in the main experiment, 4 males per dose and exposure time
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
liver
hepatocytes
Statistics:
A statistical evaluation of the results was not necessary to perform as the number of net grain counts of the groups treated with the test item were in the range of the corresponding controls.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative