Registration Dossier
Registration Dossier
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EC number: 250-001-7 | CAS number: 30007-47-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of 5-Bromo-5-Nitro-1,3-Dioxane
- Author:
- Anonymous (Cosmetic Ingredient Review 10)
- Year:
- 1 990
- Bibliographic source:
- Journal of the American College of Toxicology, Volume 9, Number 2
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: According to W. Schmid (Mut. Res. 31, 9-15, 1975 )
- GLP compliance:
- no
- Type of assay:
- other: micronucleus assay
Test material
- Reference substance name:
- 5-bromo-5-nitro-1,3-dioxane
- EC Number:
- 250-001-7
- EC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Cas Number:
- 30007-47-7
- Molecular formula:
- C4H6BrNO4
- IUPAC Name:
- 5-bromo-5-nitro-1,3-dioxane
Constituent 1
- Specific details on test material used for the study:
- 10 % in 1,2 Propylene glycol
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle used: Olive oil
Doses / concentrations
- Dose / conc.:
- 20 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
Examinations
- Statistics:
- Calculation according Kastenbaum und Bowmann
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
Any other information on results incl. tables
Table: Result of test
|
Sex |
Number |
Polychromatic erythrocytes |
Polychromatic to normochromatic erythrocytes (mean) |
Number of micro nucleated polychromatic erythrocytes mean (‰) |
Range (‰) |
Test substance |
Male |
4 |
4000 |
406 1000 |
1.75 |
1-4 |
Negative control |
Male |
4 |
4000 |
690 1000 |
1.0 |
0-2 |
Test substance |
female |
4 |
4000 |
493 1000 |
0.75 |
0-2 |
Negative control |
Female |
4 |
4000 |
761 1000 |
1.0 |
0-2 |
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.
