diethylmethoxyborane

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Adequacy of study:

other information

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EC Commission Directive 2000/32/EC Method B11 OECD Guideline 475 (1997)

GLP compliance:

yes

Type of assay:

other: in vivo mammalian bone marrow cytogenetic test

Test animals

Species:

other: Mouse NMRI BR (SPF)

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

Corn oil

No. of animals per sex per dose:

Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 18 hours
Male: 140 mg/kg; No. of animals: 5; Sacrifice time: 18 hours
Male: 140 mg/kg; No. of animals: 5; Sacrifice time: 36 hours
Male: 70 mg/kg; No. of animals: 5; Sacrifice time: 18 hours
Male: 35 mg/kg; No. of animals: 5; Sacrifice time: 18 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 18 hours
Female: 140 mg/kg; No. of animals: 5; Sacrifice times: 18 hours
Female: 140 mg/kg; No. of animals: 5; Sacrifice times: 36 hours
Female: 70 mg/kg; No. of animals: 5; Sacrifice times: 18 hours
Female: 35 mg/kg; No. of animals: 5; Sacrifice times: 18 hours

Results and discussion

Additional information on results:

Doses producing toxicity:
In animals dosed with the test material premature deaths
occurred at and above 175 mg/kg. The two animals dosed with
2000mg/kg died within 15 minutes of dosing, all other
animals dosed with >100mg/kg showed ataxia and tremors at
this time point. Other clinical signs observed at and above
140 mg/kg were as follows: lethargy, hunched posture, pale
skin, rough coat and ptosis.

The test substance demonstrated greater toxicity in males,
thus both sexes were used in the main test.

Adequate evidence of test material toxicity was demonstrated
by the intraperitoneal route; the maximum tolerated dose
was 140 mg/kg

Observations:
Within 45 minutes of dosing all animals dosed with 140mg/kg
of the test substance showed ataxia and tremors. Clinical
signs had resolved in all but three females by 17 hrs post
dosing. One of these animals died at 19 hrs and was replaced
with aa additional dosed animal.The other two animals
survived to sacrifice.

A significant reduction in the Mitotic index (39-41%) was
observed at 35 mg/kg. This was taken to confirm that
systemic absorption had occurred and exposure to the bone
marrow was achieved.

The test material did not cause a statistically significant
or biologically relevant increase in the frequency of cells
with chromosomal aberrations compared to concurrent
controls. No effects of the test substance on the number of
polyploid cells and cells with endoreplicated chromosomes
were observed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative