Registration Dossier
Registration Dossier
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EC number: 242-604-9 | CAS number: 18824-74-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study 2020
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dipotassium 3,4,5,6-tetrabromophthalate
- EC Number:
- 242-604-9
- EC Name:
- Dipotassium 3,4,5,6-tetrabromophthalate
- Cas Number:
- 18824-74-3
- Molecular formula:
- C8H2Br4O4.2K
- IUPAC Name:
- Dipotassium 3,4,5,6-tetrabromophthalate
- Test material form:
- solid
- Details on test material:
- Dried, water-free
Constituent 1
- Specific details on test material used for the study:
- Batch LP08112019
99% purity
White powder
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Reconstructed human epidermal model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- After pre-wetting tissues with 25µl Dulbecco’s Phosphate Buffered Saline a single, topical application of nominal 25mg neat test item to the surface of the EpiDermTM model
- Duration of treatment / exposure:
- 60±1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% Relative Humidity (RH))
- Duration of post-treatment incubation (if applicable):
- 42±4 hours post-treatment incubation, prior to the MTT endpoint
- Number of replicates:
- Three tissues per condition (n=3).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- ca. 6.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- No other effects recorded
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Although viabilty was lower than the positive control sodium dodecyl sulphate, it was considered within the limits to conlude Skin Irrit 2
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