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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:
1976
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Draize single insult patch test technique on the clipped intact and abraded skin of albino rabbits.
Several studies exist; in each study, 0.5 ml samples of diluted or undiluted Myristyl Myristate were applied and occluded for 24h, after which time the patch sites were evaluated for erythema and edema by the Draize technique. The sites were again graded at 72h.
The undiluted ingredient produced minimal to mild irritation.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
18

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
> 0.11 - <= 2.5
Max. score:
2.5
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.5
Max. score:
1.15
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.5
Max. score:
1.15
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met