Registration Dossier

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
Study period:
28 march 2017 to 29 march 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
yes
Remarks:
It must be noted that the certificate of analysis supplied by the sponsor is not a GLP document.
GLP compliance:
yes
Remarks:
GLP certificate in annex 1 of the final report

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
other: Reconstructed human epidermis
Cell type:
other:
Control samples:
yes, concurrent negative control
Amount/concentration applied:
after a treatment of 3 min and 1 hour (see annexes 2 and 3 of the final report)
Duration of treatment / exposure:
3 minutes at room temperature and 1 hour at 37°C +/- 1°C

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
dose of 50 µL
Duration of treatment / exposure:
3 minutes and 1 hour

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
skin 5
Value:
100.29
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
skin 6
Value:
124.78
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test item does not have to be classified in category 1 as corrosive.