Registration Dossier
Registration Dossier
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EC number: 945-003-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- The toxicity observed in this study is most likely caused by the relatively high reactivity of the diiodofluoroalkane. The PDA-3 is smaller than the primary components of the PDA-4,6 mixture, and the dediiodination reaction most likely occurs at somewhat faster rate than the PDA-4,6, but the reaction occurs in both. Because of this, the data for PDA-3 is a conservative estimation of the toxicity resulting from PDA-4,6 and so it is reasonable to read across to it.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 422-91-3
- Test material form:
- liquid
- Details on test material:
- - Purity: Not reported
- CAS: 422-91-3
Constituent 1
In vitro test system
- Test system:
- other: Epiderm™ Skin Model
- Source species:
- human
- Cell type:
- other: Epiderm™ tissues
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 or 60 minutes
- Number of replicates:
- 2/time point
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute
- Value:
- 115.3
- Positive controls validity:
- valid
- Remarks on result:
- other: Non-corrosive; pH 5
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-minute
- Value:
- 79.7
- Positive controls validity:
- valid
- Remarks on result:
- other: Non-corrosive; pH 5
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not corrosive in the in vitro skin corrosion assay using the Epiderm™ Skin Model. Three and 60 minute % viability was 115.3 and 79.7, respectively.
- Executive summary:
An in vitro skin corrosion test was performed in accordance with OECD Guideline 431. The 3 and 60 minute % viability at pH 5 was 115.3 and 79.7, respectively, indicating that the test substance was not corrosive in the in vitro skin corrosion assay using the Epiderm™ Skin Model.
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