Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2001

Materials and methods

Principles of method if other than guideline:
A study was conducted to evaluate the potential of the test material to induce micronuclei in B6C3F1 mice. After completion of a 13-wk dermal treatment period, the study animals were sacrificed and the peripheral blood samples were collected and blood smears were processed as per the standard NTP protocol. Thereafter, the slides from different test groups and control were evaluated for the induction of micronucleus.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oleic acid diethanolamine condensate (CAS 93-83-4)

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
dermal
Vehicle:
No data
Details on exposure:
No data
Duration of treatment / exposure:
13 wk
Frequency of treatment:
Assumed to be daily


Post exposure period:
Not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 50, 100, 200, 400 and 800 mg/kg bw/day
Basis:
nominal conc.
No. of animals per sex per dose:
5 animals per sex per dose were evaluated for micronuclei induction

Control animals:
yes

Examinations

Tissues and cell types examined:
Bone marrow erythrocytes
Details of tissue and slide preparation:
Tissue: Peripheral blood

Cell: Normochromatic erythrocytes

Evaluation criteria:
No data
Statistics:
No data


Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Additional information on results:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 weeks.
Executive summary:

A study was conducted to assess the clastogenic potential of the test substance in mice. The substance was applied dermally for 13 weeks at 0, 50, 100, 200, 400 and 800 mg/kg bw. Peripheral blood samples were obtained from male and female animals, and smears were immediately prepared and fixed in absolute methanol. Under the conditions of the study, the test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 weeks (NTP, 2001).