Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Qualifier:
according to
Guideline:
EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
GLP compliance:
yes
Type of assay:
other: peripheral blood samples in mammalian erythrocytes micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: gas
Vehicle:
Air and supplemental oxygen
Duration of treatment / exposure:
20 days of exposure
Frequency of treatment:
6 hours/day, 5 days/week
Post exposure period:
Not specified
Doses / concentrationsopen allclose all
Dose / conc.:
0 ppm
Dose / conc.:
2 500 ppm
Dose / conc.:
10 000 ppm
Dose / conc.:
50 000 ppm
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
yes
Positive control(s):
No

Examinations

Tissues and cell types examined:
Approximately 6-8 drops of blood (peripheral blood samples) was collected by tail vein venipuncture from the 5 rats/sex/group. There were two blood collections, one following the fourth exposure (test day 3) and following the last exposure before scheduled euthanasia.
Cell types examined were immature erythrocytes and normochromatic erythrocytes.
Details of tissue and slide preparation:
No information
Evaluation criteria:
Results considered positive if:
- statistically significantly increase mean MN-RETs (micronucleated reticulocytes) observed at one or more concentrations of test substance compared to concurrent negative control values
- statistically significant dose-response increase in MN-RETs observed
Statistics:
Yes

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:
No statistically significant increases in the frequency of MN-RETs compared to the negative control group were observed in any evaluated test substance treated group of male or female rats at any time point. There were no statistically significant test substance-related decreases in %RET. The negative control group exhibited a response consistent with the %MN-RETs historical control data.