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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliable without restriction, test procedure according to national standards (DIN, etc.)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974
Reference Type:
secondary source
Title:
Final report of the safety assessment for oleic acid, lauric acid, palmitic acid, myristic acid, stearic acid
Author:
CIR
Year:
1987
Bibliographic source:
JACT, 6(3): 321-401

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Patch test / Revised (1964) Federal Hazardous Substance Act
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: no data given

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
Fur was removed from the back of each of six rabbits by clipping the saddle of the trunk area. One area of skin was abraded by making minor incisions with a hypodermic needle. 0.5 ml of test material was applied to 1 in2 gauze patches. The patches were placed on both intact skin and abraded skin of each rabbit and secured with adhesive tape, rubber dental damming secured with staples, and gauze wound loosely around the trunk. The animals were then immobilized for 24 hours in wooden stocks. After 24 hours, the patches were removed and the skin cleaned by gently sponging with a moistened towel. The skin was examined immediately after removal of the patches (24 hr reading) and again at 72 hrs. At each examination the skin was scored for presence and severity of erythema/eschar formation and edema formation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other:
Time point:
other: 24 hours
Score:
0
Max. score:
8
Reversibility:
other: not effects noted
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritant / corrosive response data:
No signs of skin irritation were observed on intact or abraded sites at either scoring time point.

Any other information on results incl. tables

Material (0.5 ml) was applied via a one-inch-square surgical gauze patch to intact and abraded-skin sites. Patches were held in place for 24 hours. Reactions were scored immediately after patch removal and two days later (72 hours).

Scores for Skin Irritation

Rabbit No.

24 hrs

72 hrs

43

Intact

     Erythema-Eschar

     Edema

Abraded

     Erythema-Eschar

     Edema

0    

0

0

0

0

0

0

0

44

Intact

     Erythema-Eschar

     Edema

Abraded

     Erythema-Eschar

     Edema

0    

0

0

0

0

0

0

0

45

Intact

     Erythema-Eschar

     Edema

Abraded

     Erythema-Eschar

     Edema

0    

0

0

0

0

0

0

0

46

Intact

     Erythema-Eschar

     Edema

Abraded

     Erythema-Eschar

     Edema

0    

0

0

0

0

0

0

0

47

Intact

     Erythema-Eschar

     Edema

Abraded

     Erythema-Eschar

     Edema

0    

0

0

0

0

0

0

0

48

Intact

     Erythema-Eschar

     Edema

Abraded

     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: EU