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:
Novemver-December 1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. The analytical purity of the substance in the test product was not reported. Instead, it was based upon the estimated ranges for the product derived from the production recipe.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
Method of Draize, as described in "Appraisal of the Safety of Chemicals in Food, Drugs and Cos­metics", published by the Association of Food and Drug Officials of the United States.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ceraphyl 424
- Analytical purity: mixture of tetradecyl myristate, tetradecyl laurate and tetradecanol (approx. 60-30-10 %w/w)
- Received: November 13, 1975

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No details

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both clipped and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
48 h
Number of animals:
3
Details on study design:
Three healthy, normal, albino rabbits were used for this experiment. On the day prior to the experiment 10% of the total body area of the rabbits was carefully clipped free of all hair. Small animal clippers were used since these left the skin undisturbed. On the posterior of the clipped area several minor abrasions were made so as to penetrate the stratum corneum but not disturb the derma. This is to prevent bleeding.
0. 5 gm. of the test material was patched over the scarified area and 0. 5 gm. over the unscarified area. The 2 x 2 patch area was covered with Webril patches and the entire experimental area sealed with Blenderm Surgi­cal Tape. The animals were immobilized in racks for a twenty-four hour period.
At the end of the twenty-four hour contact period and again forty-eight hours later the trE:ated skin was evaluated according to the method of Draize, as described in "Appraisal of the Safety of Chemicals in Food, Drugs and Cos­metics", published by the Association of Food and Drug Officials of the United States.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
4

Any other information on results incl. tables

Erythema and Eschar Formation Score
Intact Skin 24 h 1
72 h 0
Abraded Skin 24 h 1
72 h 0
Edema Formation
Intact Skin 24 h 0
72 h 0
Abraded Skin 24 h 0
72 h 0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Since the test material, when evaluated as described above, produced a primary irritation index of 1 it can be classified as a mild primary irritant.