Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good documented study, although not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: the patch test method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Rhubafurane
dated on 09.09.1980
clear slightly yellow liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours after application
Number of animals:
6 animals (intact skin); 6 animals (abraded skin)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.667
Max. score:
2
Reversibility:
not fully reversible within: 72 hours except for rabbit number #5
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1.667
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.667
Max. score:
2
Reversibility:
not fully reversible within: 72 hours except for the rabbit number#11
Remarks on result:
other: abraded skin

Any other information on results incl. tables

Table 3: Individual and Average Skin Irritation Scores

Rabbit number

Intact skin

Rabbit number

Abraded skin

24 hours

72 hours

24 hours

72 hours

E

O

E

O

E

O

E

O

1

4

2

3

1

1

4

2

4

2

2

1

0

1

1

2

1

0

2

1

3

2

1

1

1

3

0

0

0

0

4

1

0

2

1

4

1

1

4

1

5

1

1

1

0

5

1

1

1

0

6

0

0

2

1

6

0

0

1

1

Average

2.2

2.5

Average

1.8

2.8

E = Erythema

O = Oedema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Reactions insufficient for classification. Criteria used for interpretation of results: other: GHS EU
Conclusions:
Reactions insufficient for classification.