Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
water
Duration of treatment / exposure:
4 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max duration 24d. Max value at end of observation period (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Max. score:
1
Remarks on result:
other: Max duration 24d. Max value at end of observation period (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 1 day
Other effects:
Maximum grade 1 erythema and edema were observed in one or more animals prior to the 24 hour observation, becoming insignificant by this time

Applicant's summary and conclusion

Interpretation of results:
other: not classified