Registration Dossier
Registration Dossier
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EC number: 215-145-7 | CAS number: 1306-06-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 4. Nov. 2016 to 24. Nov. 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Annex 2d Test procedure with the Starting Dose of 2000 mg/kg bw
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Slovak National Accreditation Service, Karlovská 63, 840 00 Bratislava 4, Slovak Republic
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- females, non-pregnant and nulliparous, 8-12 weeeks old, healthy (examined before initiation of the study), each animal marked with an ID number (cages marked, animals marked on the tail with an ink marker)
housed in plastic cages suspended on stainless steal racks, up to 3 animals per cage, Lignocel S3/4 bedding
laboratory food in recommended doses each day at the same time, tap water ad libitum
temperature: 22 +/- 3°C, relative humidity: 50-60%, 12-hours light/12-hours dark cicle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2 x 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 x 3 females
- Control animals:
- no
- Details on study design:
- according to Annex 2d: Test Procedure with aStarting Dose of 2000 mg/kg body weight of OECD Guideline 423
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- other: LD50 higher than 2000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
- Clinical signs:
- other: no signs of toxicity observed
- Gross pathology:
- no macroscopic findings after necropsy
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test sustance is not toxic under the conditions of this experiment.
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