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:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: removed with clippers
Vehicle:
other: None
Controls:
other: additional site was similarily treated with the exception of the test substance
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Irritation parameter:
erythema score
Max. score:
2
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 2 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 14 days
Other effects:
There was no sign of toxicity or ill health in any rabbit
during the observation period.

Very-slight or well-defined erythema was evident in all
animals throughout the first 72 hours after bandage removal
and in one case on Day 8. Exfoliation was present in all
animals seven days after bandage removal persisting in one
case one week later.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
The Primary Irritation Index was calculated to be 1.7; Trimofix O was classified as ‘mildly irritating’ according to the criteria of the ECETOC and required labelling with the risk phrase R38, “Irritating to skin”, in accordance with Commission Directive 2001/59/EC.
Executive summary:

The Primary Irritation Index was calculated to be 1.7; Trimofix O was classified as ‘mildly irritating’ according to the criteria of the ECETOC and required labelling with the risk phrase R38, “Irritating to skin”, in accordance with Commission Directive 2001/59/EC.