Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Arcton 22
IUPAC Name:
Arcton 22
Details on test material:
no data

Test animals

Species:
mouse
Strain:
C57BL
Sex:
male/female
Details on test animals or test system and environmental conditions:
C57BL/6JfCD-1/Alpk

Administration / exposure

Route of administration:
inhalation: vapour
Details on exposure:
Mice were exposed to vapor concentrations
of 0 (5 mice/sex), 50,000 (5 mice/sex) or 150,000 ppm (15 mice/sex) for 6
hours in a dynamic air-flow chamber.
Duration of treatment / exposure:
6 hours
No. of animals per sex per dose:
0 (5 mice/sex), 50,000 (5 mice/sex) or 150,000 ppm (15 mice/sex)
Positive control(s):
no data

Examinations

Tissues and cell types examined:
Mice were sacrificed and bone marrow
was examined for micronucleated polychromatic erythrocytes at 24 hours
after treatment with 50,000 ppm, and 24, 48, or 72 hours after treatment
with 150,000 ppm.
Details of tissue and slide preparation:
no data
Evaluation criteria:
examination of micronucleated polychromatic erythrocytes
Statistics:
no data

Results and discussion

Additional information on results:
The frequency of micronucleated polychromatic
erythrocytes did not increase in any of the treatment groups, indicating
that Arcton 22 was not clastogenic in mice under the conditions of this
assay.

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: not clastogenic
Executive summary:

In a test for

clastogenicity mice were exposed to vapor concentrations of 0 (5 mice/sex), 50,000 (5 mice/sex) or 150,000 ppm (15 mice/sex) for 6 hours in a dynamic air-flow chamber. The frequency of micronucleated polychromatic erythrocytes did not increase in any of the treatment groups.So it was considered that Arcton 22 was not clastogenic in mice under test conditions.