Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid without restriction. Well documented GLP study.

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)
Deviations:
no
Principles of method if other than guideline:
EPA Guideline 81-5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
4 hours
Observation period:
The skin was examined at 0.5, 24, 48, and 72 hours after removal of the patches.
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 4.5, 24, 48 and 72 h score average
Score:
0

Any other information on results incl. tables

Rabbit No.

 

0.5

hrs

24

hrs

48 hrs

72

hrs

599

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

600

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

601

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

602

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

603

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

604

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Primary dermal irritation index (4.5, 24, 48 and 72 h score average) was 0. Not irritating.