Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: extracted from ECHA database
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
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:
not specified
Vehicle:
other: distilled water (0.5 ml)
Amount / concentration applied:
5 mg
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:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
Reversibility of any observed effect: changes not fully reversible within 14 days
Other effects:
Desquamation was noted in one animal at the 48 and 72 hours observations.
Haemorrhage of the dermal capillaries was observed in one treated animal (no.2). All treated skins had returned to normal by day 7, apart from desquamation or hyperkeratinisation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information