Registration Dossier

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientific acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Principles of method if other than guideline:
10 mice (5 male + 5 female) received a single oral application of 0.1 ml/kg bw of the test substance. Animals were killed after 24, 48 and 72 hours and bone marrow was reprocessed. 1000 polychromatic erytrocytes were evaluated and the number of normochromatic erythrocytes counted. Additionally micronucleated cells per 1000 normochromatic and polychromatic erythrocytes were determined.
GLP compliance:
not specified
Type of assay:
mammalian bone marrow chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Mixture of isomers of ditoly ether

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
Male + female NMRI-mice, SPF, ca. 8 - 12 weeks old, weight 24- 34 g, husbandry: conventional in makrolon cages typ II, maximal 5 animals per cage, separated by sex and test groups.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Test substance was applicated in peanut oil, positive controls were applied in deionized water, negative controls reveived peanut oil.
Details on exposure:
No further data.
Duration of treatment / exposure:
24, 48 or 72 hours.
Frequency of treatment:
single application
Post exposure period:
animals were sacridied after 24, 48 or 72 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
103.5 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
10 animals (5 males + 5 females)
Control animals:
yes, concurrent vehicle
Positive control(s):
10 animals received 29.5 mg endoxan/kg bw

Examinations

Tissues and cell types examined:
1000 polychromatic erytrocytes were evaluated and the number of normochromatic erythrocytes counted. Additionally micronucleated cells per 1000 normochromatic and polychromatic erythrocytes were determined
Statistics:
According Wilcoxon.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Treated animals revealed no signs of poisoning and survived until sacrifice.

Any other information on results incl. tables

No signs of a mutagenic effect after a single oral application of 0.1 ml/kg of the test substance.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Executive summary:

Method: 10 mice (5 male + 5 female) received a single oral application of 0.1 ml/kg bw of the test substance. animals were killed after 24, 48 and 72 hours and bone marrow was reprocessed. 1000 polychromatic erytrocytes were evaluated and the number of normochromatic erythrocytes counted. Additionally micronucleated cells per 1000 normochromatic and polychromatic erythrocytes were determined.

Result: no indication for a mutagenic effect was found. treated animals revealed no signs of poisoning and survived until sacrifice.

Reference: Herbold (Bayer AG), 1984.