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:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
ca. 55% active substance (moist; water)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Duration of treatment / exposure:
4 h
Number of animals:
1 male
2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1,24,48,72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1,24,48,72 h
Score:
0

Any other information on results incl. tables

The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm2 intact dorsal skin of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No signs of irritation were observed. The test article caused violet staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), the test article is considered to be "not irritating" to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), the test article is considered to be "not irritating" to rabbit skin.
Executive summary:

not irritating