Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study, equivalent or similar to OECD Guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid
EC Number:
204-007-1
EC Name:
Oleic acid
Cas Number:
112-80-1
Molecular formula:
C18H34O2
IUPAC Name:
octadec-9-enoic acid
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both test sites clipped, one abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1.5x1.5 inch
- Type of wrap if used: plastic trunk bands

REMOVAL OF TEST SUBSTANCE
- Washing: all test sites were washed with solvent
- Time after start of exposure: 4 hours after application, after the first reading

SCORING SYSTEM:
The primary irritation index is calculated by adding the values for erythema or eschar fonnation, and ederna at 4 I 24 and 48 hours on intact and abraded skin (12 values) and dividing by six to obtain an individual score on each rabbit.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h / 48 h
Score:
0.04
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h / 48 h
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h / 48 h
Score:
0.04
Max. score:
8
Reversibility:
fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU