Registration Dossier
Registration Dossier
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EC number: 201-557-4 | CAS number: 84-74-2
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:
- 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:
- 2 004
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
- 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.
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
