Registration Dossier
Registration Dossier
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EC number: 215-145-7 | CAS number: 1306-06-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 11. Nov. 2015 to 01.Dec. 2015
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Mainzer Str. 80, D-65189 Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- females (non-pregnant and nulliparous), healthy (checked 5 days prior to the experiment)
environment: temperature 22+/-2°C, trel. humidity. approx. 45-65%, artificial light from 6.00a.m. - 6.00p.m.
Cage with wire mesh top, granulated soft bedding, certified rodent diet and tap water ad libitum
pre-test. 2 animals identified by cage number, test: 16 animals identified by tail tags. All animals belonging to the same experimental group were kept together in one cage.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- 25% suspension (highest level achieved)
- Concentration:
- 25µl for the dorsal surface of each ear on 3 consecutive days
pre-test: 10% and 25%
test: 5%, 10%, 25%, negative control: vehicle, - No. of animals per dose:
- 4
- Details on study design:
- clinical signs checked dayly,
body weights, ear thickness and ear weights were reported - Statistics:
- no, poole lymph node assay
Results and discussion
- Positive control results:
- historical data from Oct. 2015 (with a-hexyl cinnamaldehyde in acetone/olive oil (4+1, v/v) reported
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Remarks:
- EC3 values not calculated because all Si under 3
- Value:
- > 2
- Variability:
- 1.43 - 1.26 - 1.71
- Test group / Remarks:
- negative control group: SI = 1, positive control group (hist.): SI = 17.56 (25%)
- Remarks on result:
- other: no skin irritation
- Cellular proliferation data / Observations:
- no clinical signs (systemic or local on the ears) or uncommon changes in body weights were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not a skin sensitizer under the conditions of this experiment.
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