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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:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976-09-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Short description of test conditions:
Metaphase cells from bone marrow preparations of the animals were scored for structural chromosomal aberrations. A total of 100 metaphases from each animal were scored.
GLP compliance:
not specified
Type of assay:
mammalian bone marrow chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name: tertiary-butyl glycidyl ether
- CAS No. : 7665-72-7
- Lot No. : 21311-34GWS
- Supplier: Shell

Test animals

Species:
mouse
Strain:
other: B6D2F1
Sex:
female
Details on test animals and environmental conditions:
- Weight: 20 - 25 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Vehicle used: Corn oil
Details on exposure:
- Dilutions of t-BGE in corn oil were administered orally once a day for five days to separate groups of ten B6D2F1 female mice
- The positive control compounds were administered only twice.
- All animals were sacrificed 4 hours after the last treatment.
Duration of treatment / exposure:
5 days
Frequency of treatment:
once a day
Doses / concentrationsopen allclose all
Dose / conc.:
100 mg/kg bw/day
Dose / conc.:
200 mg/kg bw/day
Dose / conc.:
400 mg/kg bw/day
No. of animals per sex per dose:
10 females
Control animals:
yes, concurrent vehicle
Positive control(s):
Cytoxan and hycanthone were used as positive controls

Examinations

Tissues and cell types examined:
Metaphase cells from bone marrow preparations were used for scoring of structural DNA damage.

Results and discussion

Test results
Key result
Sex:
female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
The frequency of gaps was essentially the same for both treated and control groups. The known positive controls Cytoxan and hycanthone demonstrated frequencies of damaged cells in the same range as prvious studies conducted in this laboratory. This test showed no differences between the control and the t-BGE dosage group oin the percentage of metaphases with chromosomal damage.

Applicant's summary and conclusion

Conclusions:
In an in-vivo cytogenicity toxicity test, t-BGE was orally exposed to ten female B6D2F1mice weighing 20 - 25 g at concentrations of 100 - 400 mg/kg once per day for five consecutive days. All animals were sacrificed 4 hours after the last treatment. Extraction of bone marrow, preparation of smears, staining and analysis was conducted and the metaphase cells from bone marrow preparations were scored for structural chromosomal aberrations. A total of 100 metaphases from each animal were scored. The frequency of gaps was essentially the same for both treated and control groups. The known positive controls Cytoxan and hycanthone demonstrated frequencies of damaged cells in the same range as prvious studies conducted in this laboratory. This test showed no differences between the control and the t-BGE dosage group oin the percentage of metaphases with chromosomal damage.
Executive summary:

In an in-vivo cytogenicity toxicity test, t-BGE was orally exposed to ten female B6D2F1mice weighing 20 - 25 g at concentrations of 100 - 400 mg/kg  once per day for five consecutive days. All animals were sacrificed 4 hours after the last treatment. Extraction of bone marrow, preparation of smears, staining and analysis was conducted and the metaphase cells from bone marrow preparations were scored for structural chromosomal aberrations. A total of 100 metaphases from each animal were scored. The frequency of gaps was essentially the same for both treated and control groups. The known positive controls Cytoxan and hycanthone demonstrated frequencies of damaged cells in the same range as prvious studies conducted in this laboratory. This test showed no differences between the control and the t-BGE dosage group oin the percentage of metaphases with chromosomal damage.