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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
other: pre draft study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

In vitro test system

Test system:
artificial membrane barrier model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: not specified
Source strain:
not specified
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
as poder
Duration of treatment / exposure:
3min, 60 min
Duration of post-treatment incubation (if applicable):
3min, 60 min

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min
Value:
41
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
100
Positive controls validity:
valid
Remarks:
16.3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 min
Value:
0
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
100
Positive controls validity:
valid
Remarks:
4.8

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The outcome of the study predicted, that the test substance is corrosive to skin