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 irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
dose of 0.5 g
Duration of treatment / exposure:
4 hours
Number of animals:
3
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1,24,48,72 hours).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

On the basis of the Registrant's experience, the substance causes skin and eye irritation.