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:
other: data submitted by ECHA
Title:
Unnamed
Year:
1989

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 h
Score:
1
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 h
Score:
3
Max. score:
3
Other effects:
Grade 1-2 oedema was observed in all three animals at 30-60 minutes after patch removal. The maximum score for oedema during the 3-day observation period was 3, and by 3 days the oedema scores were 3 , 1 and 0. At 3 days skin samples were taken for histopathological examination. All 3 samples showed acanthosis (slight in 2, moderate in 1) and inflammatory cell infiltration (slight in 2, moderate in 1).

Applicant's summary and conclusion