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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
chromosome aberration assay
Test material information:
Composition 1
Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
According to Guideline.
Route of administration:
oral: gavage
Vehicle:
Distilled water
Duration of treatment / exposure:
n.a.
Frequency of treatment:
Once
Post exposure period:
test group: 10, 24 and 48 hpositive control: 26 h
Remarks:
Doses / Concentrations:0, 1000, 2000 mg/kg bwBasis:nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide (50 mg/kg bw)
Tissues and cell types examined:
Femoral bone marrow cells
Details of tissue and slide preparation:
SAMPLING TIMEStest groups: 10, 24 and 48 h after treatmentpositive control group: 26 h after treatment
Evaluation criteria:
According to Guideline.
Statistics:
Yes
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Conclusions:
negative

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Distilled water
Duration of treatment / exposure:
n.a.
Frequency of treatment:
Once
Post exposure period:
test group: 10, 24 and 48 hpositive control: 26 h
Doses / concentrations
Remarks:
Doses / Concentrations:0, 1000, 2000 mg/kg bwBasis:nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide (50 mg/kg bw)

Examinations

Tissues and cell types examined:
Femoral bone marrow cells
Details of tissue and slide preparation:
SAMPLING TIMEStest groups: 10, 24 and 48 h after treatmentpositive control group: 26 h after treatment
Evaluation criteria:
According to Guideline.
Statistics:
Yes

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
negative