Registration Dossier
Registration Dossier
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EC number: 215-145-7 | CAS number: 1306-06-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26. Oct. 2015 to 28. Jan. 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, D-55116 Maniz, Germany
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 vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: EpiDerm(TM): Culture of human-derived epidermal keratinocytes forming a multi-layered, highly differentiated model of the human epidermis
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava
- Source strain:
- not specified
- Justification for test system used:
- according to OECD guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- wettted with 25µL DPBS buffer
- Details on test system:
- EpiDerm(TM)-kit EPI-212-SIT, batch no. 23302
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- other: As blank, the optical density of isopropanol was measured in 8 wells of the plate.
- Amount/concentration applied:
- tissue1: 23.0mg, tissue 2: 22.5mg, tissue3: 24.4mg
- Duration of treatment / exposure:
- 60 min.
- Duration of post-treatment incubation (if applicable):
- 22h
- Number of replicates:
- 2 x 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- as formazan production, negative control = 100%
- Value:
- 2.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- viability measured via MTT reduction as optical density
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritation under the conditions of this test.
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