Registration Dossier
Registration Dossier
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EC number: 950-052-1 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo insect germ cell study: gene mutation
- 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:
- In vivo genotoxicity assessment of titanium, zirconium and aluminium nanoparticles, and their microparticulated forms, in Drosophila
- Author:
- Demir, E et al
- Year:
- 2 013
- Bibliographic source:
- Chemosphere Volume 93, Issue 10, November 2013, Pages 2304-2310
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.20 (Sex-linked Recessive Lethal Test in Drosophila melanogaster)
- GLP compliance:
- not specified
- Type of assay:
- Drosophila SLRL assay
Test material
- Reference substance name:
- Zirconium dioxide
- EC Number:
- 215-227-2
- EC Name:
- Zirconium dioxide
- Cas Number:
- 1314-23-4
- Molecular formula:
- O2Zr
- IUPAC Name:
- Zirconium dioxide
Constituent 1
Test animals
- Species:
- Drosophila melanogaster
- Details on species / strain selection:
- Two strains : multiple wing hairs strain with the genetic constitution y; mwh j; and the flare-3 strain with the genetic constitution, flr3/In (3LR) TM3, Bds.
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Prepared in distilled water
- Details on exposure:
- Microparticulated 0.1, 1, 5 and 10 mM in feed
- Duration of treatment / exposure:
- Three day old larvea until pupation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.1 other: mM
- Dose / conc.:
- 1 other: mM
- Dose / conc.:
- 5 other: mM
- Dose / conc.:
- 10 other: mM
- No. of animals per sex per dose:
- Between 10 and 20
- Control animals:
- yes, concurrent vehicle
- other: Positive control ethyl methanesulfonate (EMS)
- Positive control(s):
- Ethyl methanesulfonate (EMS)
Examinations
- Tissues and cell types examined:
- Wing spot
- Statistics:
- Conditional binomial test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Although not following normal guidelines, the outcome of the study considering metal salts is considered valid.
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