(tert-butoxymethyl)oxirane

Genetic toxicity: in vivo

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

Test material information

Constituent 1

Reference substance name:

(tert-butoxymethyl)oxirane

EC Number:

231-640-0

EC Name:

(tert-butoxymethyl)oxirane

Cas Number:

7665-72-7

Molecular formula:

C7H14O2

IUPAC Name:

2-[(tert-butoxy)methyl]oxirane

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 or test system 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 / concentrations

Doses / concentrations 1

Dose / conc.:

100 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

200 mg/kg bw/day

Doses / concentrations 3

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.