Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

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).