Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
0.5 g (paste with purified water) 4h semi-occlusive dressing: TS 70% in 30% NaHCO3

Test animals

Species:
rabbit
Strain:
Flemish Giant

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: TS 70% in 30% NaHCO3
Controls:
not required
Duration of treatment / exposure:
4 hours
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acetyl salicylic acid is not irritanty on rabbit skin, while the Na
Executive summary:

Acetyl salicyl acid was not irrtant for rabbit skin in ancted according to B4 EU method.