Ditolyl ether

Genetic toxicity: in vivo

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

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

Test material information

Constituent 1

Reference substance name:

Ditolyl ether

EC Number:

248-948-6

EC Name:

Ditolyl ether

Cas Number:

28299-41-4

Molecular formula:

C14H14O

IUPAC Name:

Benzene, 1,1'-oxybis[methyl-

Details on test material:

Mixture of isomers of ditoly ether

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system 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.