Registration Dossier
Registration Dossier
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EC number: 215-145-7 | CAS number: 1306-06-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydroxylapatite (Ca5(OH)(PO4)3)
- EC Number:
- 215-145-7
- EC Name:
- Hydroxylapatite (Ca5(OH)(PO4)3)
- Cas Number:
- 1306-06-5
- Molecular formula:
- Ca5HO13P3
- IUPAC Name:
- pentacalcium hydroxide triphosphate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Hydroxyapatite with zirconia added (to make it tougher), whitish grey fine powder, aseptic precautions taken when handling the substance
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA98, TA100, TA1535, TA1537 and E.coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- 5000, 2500, 1250, 625 and 313 µg/plate
top dose according to guideline for non-cytotoxic substances, cytotoxicity tested (= not cytotoxic)
Controls
- Untreated negative controls:
- no
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3(5-nitro-2-furyl)acrylamide, Sodium azide, 2-d-2-Aminoanthracene, Methoxy-6-chloro-9(3-(2-chloroethyl)-aminopropylamino)acrinidine
- Details on test system and experimental conditions:
- pre-incubation method
negative control: triplicate, positive controls and treatment: duplicate, control for bacterial contamination of the agar plates: once - Rationale for test conditions:
- according to guideline
- Evaluation criteria:
- number of revertant colonies equal or less than negative control, reproducible effects (duplicates),no concentration-dependent effects
- Statistics:
- The colonies were counted with a manual counter or a colony analizer. Each plate was counted 3 times and the mean was given. The average plate count for each dose was calculated as the average of the duplicates.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537 and E.coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- The test substance is not mutagenic under this test conditions.
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