Registration Dossier
Registration Dossier
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EC number: 201-553-2 | CAS number: 84-69-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study, animal experimental study with minor restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
- Principles of method if other than guideline:
- Peripherable blood taken after 13 week continuous feeding fo rats to up to 40,000 ppm in DBP in the diet. - detailed in MacGregor et al (1990)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- IUPAC Name:
- dibutyl phthalate
- Details on test material:
- > 99% pure
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Examinations
- Statistics:
- The frequency of micronucleated cells among normochromatic erythrocytes was analyzed by a statistical software package (ILS, 1990) that employed a one-tailed trend test across exposure groups and a t-test for pairwise comparisons of each exposure group to the concurrent control.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
Any other information on results incl. tables
Analyses of peripheral blood samples taken from male and female mice at the end of the 13-week study revealed no increased incidences of micronucleated normochromatic erythrocytes in males or females.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
DBP did not cause an increased incidences of micronucleated normochromatic erythrocytes in males or female rats after a 13 week dosing period.
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