Registration Dossier
Registration Dossier
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EC number: 203-090-1 | CAS number: 103-23-1
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of a three-exposure mouse bone marrow micronucleus protocol: Results with 49 chemicals.
- Author:
- Shelby, M.D., Erexson, G.L., Hook, G.J. and Tice, R.R.
- Year:
- 1 993
- Bibliographic source:
- Environmental and molecular mutagenesis 21: 160-179
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- Supplier: NTP chemical repository (Radian Corporation, Austin, TX).
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Corn oil.
- Duration of treatment / exposure:
- Three consecutive days.
- Frequency of treatment:
- Three daily treatments.
- Post exposure period:
- A single sample was taken 24 hours after the final treatment (injection).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
375, 750, 1500, 2000 mg/kg
Basis:
analytical conc.
- No. of animals per sex per dose:
- 5 male mice per dose.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 7,12-dimethylbenzanthracene (DMBA).
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow.
Cells: erythrocytes.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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