Registration Dossier
Registration Dossier
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EC number: 812-508-7 | CAS number: 1093112-19-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 04. Feb. 2016 to 25. Feb. 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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany
Test material
- Reference substance name:
- reaction product of alumina and sulfuric acid
- EC Number:
- 812-508-7
- Cas Number:
- 1093112-19-6
- Molecular formula:
- unspecified, UVCB substance
- IUPAC Name:
- reaction product of alumina and sulfuric acid
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified, EpiDerm(TM), procured from MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Source strain:
- not specified
- Justification for test system used:
- species of interest: Human, three-dimensional skin model, comprising a reconstructed epidermis witha functional stratum corneum
appication topically as may occur by skin contact - Vehicle:
- other: the solid test substance was applied together with 25 µl of water
- Details on test system:
- commercially available EpiDerm(TM)-kit procured from MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
designation: EPI-200-EACH - Amount/concentration applied:
- Tissue 1: 24.8 mg (3 minutes incubation) and 25.3 mg (1 hour incubation)
Tissue 2: 25.1 mg (3 minutes incubation) and 24.5 mg (1 hour incubation) - Duration of treatment / exposure:
- 2 minutes or 1 hour
- Duration of post-treatment incubation (if applicable):
- incubation with MTT reagent for 3 h
- Number of replicates:
- 2 x 2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- relative absorbance value (%)
- Run / experiment:
- after 3 minutes treatment: 93.4%, after 1 h treatment: 93.7%
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- water demin.
- Positive controls validity:
- valid
- Remarks:
- KOH, 8.0 mol/l
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sulfuric acid, reaction product with alumina is considered as non-corrosive in the Human Skin Model Test.
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