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Toxicological information

Skin irritation / corrosion

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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:
2014
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

Constituent 1
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

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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