Registration Dossier
Registration Dossier
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EC number: 946-354-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- Remarks:
- Laus GmbH Kirrweiler
Test material
- Reference substance name:
- Phosphoric acid, chromium(3+) salt (1:2.5)
- EC Number:
- 946-354-8
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- Phosphoric acid, chromium(3+) salt (1:2.5)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes, EpiDermTM-Kit, procured by MatTek
- Cell source:
- other: not specified
- Justification for test system used:
- According to guideline
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 30 µL test item
- Duration of treatment / exposure:
- 1 h
- Duration of post-treatment incubation (if applicable):
- 23 h + 19h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three tissues
- Value:
- 69.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substanceis considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
Three tissues of the human skin model EpiDermTM were treated with the test substance for 60 minutes. After the treatment with the test substance, the mean value of relative tissue viability was re-duced to 69.9 %. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
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