Registration Dossier
Registration Dossier
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EC number: 215-145-7 | CAS number: 1306-06-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- other: Bone Marrow Abberation Test
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
Test animals
- Species:
- mouse
- Strain:
- other: Swiss Albino Strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Animal House Unit of the USM Health Campus
adult, healthy mice (10-12 weeks old), body weights: females: 29.51+/-0.22g, males: 36.28+/-0.37g
reared in cages, comercial pellet diet and distilled water ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- distilled water
- Duration of treatment / exposure:
- 6, 24, 48 hours
- Frequency of treatment:
- once
- Post exposure period:
- 90 min. before sacrifice: intraperitoneally injection of caochicine (4mg/kg)
Doses / concentrations
- Remarks:
- 2000mg/kg body weight (synthetic hydroxyapatite granules, porous form, 100 - 200 microns in size, dispersed in 0.5ml of distilled water)
- No. of animals per sex per dose:
- 5 females + 5 males per dose, 3 doses
+ negative control group + positive control group - Control animals:
- yes
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C (1.5 mg/kg bw), killed 24 hours after treatment
Examinations
- Tissues and cell types examined:
- bone marrow from both femurs
- Details of tissue and slide preparation:
- The cells were flushed in water, centrifuged, fixed on slides and stained with Leishman's stain in phosphate buffered saline. A total of 100 metaphase cells per animal were scored under a microscope for chomosomal abberations, documented by photographs. Then the mitotic index as mean of 10 animals was calculated.
- Statistics:
- mean values, standard errors and satistical evaluation following ANOVA tset and subsequent comparing with Duncan's newe multiple range test values
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The teswt subsstance is not genotoxic under the conditions of this test.
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