Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: taken from EU RAR

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
n/a
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl phthalate
EC Number:
201-557-4
EC Name:
Dibutyl phthalate
Cas Number:
84-74-2
Molecular formula:
C16H22O4
IUPAC Name:
dibutyl phthalate
Test material form:
not specified
Details on test material:
DBP was administered to mice in a diet (equal to 163-4278 mg/kg bw) for 13 weeks.

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
no data
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.125, 0.25, 0.5, 1.0, 2.0% in diet
Basis:
nominal in diet
No. of animals per sex per dose:
no data
Control animals:
yes

Examinations

Tissues and cell types examined:
peripheral blood samples
Details of tissue and slide preparation:
no data

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No increased incidence of micronuclei was revealed.

Applicant's summary and conclusion

Categories Display