Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes
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
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
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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Data from OECD 412 study show no adverse effect

Justification for selection of eye irritation endpoint:
mechanical irritation of cornea by stubstance

Effects on eye irritation: irritating

Justification for classification or non-classification