Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987, not specified.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP. Reported under EC 793/93 for Existing substances regulations. Full methodology etc not available. Deemed reliable as evaluated by the European Commission. This data is considered the property of the data submitter. However it has not been possible to locate the study report due to re-organisation associated with the merger.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Version / remarks:
Described as OECD Guideline 475 "Genetic toxicology: In vivo mammalian bone marrow cytogenic test - Chromosomal analysis".
Deviations:
not specified
GLP compliance:
yes
Type of assay:
other: somatic mutation assay (Chinese hamster)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Reofos 50
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: not specified
- Physical state: not specified
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals

Species:
hamster, Chinese
Strain:
other: Cricetulus grinseus
Sex:
male/female
Details on test animals and environmental conditions:
Not specified.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Not specified.
Details on exposure:
24 male and 24 female hamsters were administered the test material once at a dosage of 5000 mg/kg. Eight hamsters were sacrificed 16 hours, 24 hours and 48 hours later and bone marrow from the femurs were evaluated for aberrations. Both positive and negative control groups were also run.
Duration of treatment / exposure:
16, 24 or 48 hours
Frequency of treatment:
single dose, 5000 mg/kg
Post exposure period:
None.
Doses / concentrations
Remarks:
Doses / Concentrations:
5000 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
24
Control animals:
yes
Positive control(s):
yes, not specified.

Examinations

Tissues and cell types examined:
bone marrow from the femurs
Details of tissue and slide preparation:
Not specified.
Evaluation criteria:
Not specified.
Statistics:
Not specified.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
There was no evidence of mutagenic effects in this study

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
There was no evidence of mutagenic effects in this study
Executive summary:

There was no evidence of mutagenic effects in this study.

This data is provided as supporting information only.