Tetradecyl laurate

Skin irritation / corrosion

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

Test material information

Constituent 1

Reference substance name:

Tetradecyl laurate

EC Number:

244-966-3

EC Name:

Tetradecyl laurate

Cas Number:

22412-97-1

Molecular formula:

C26H52O2

IUPAC Name:

tetradecyl laurate

Constituent 2

Reference substance name:

Tetradecyl myristate

EC Number:

221-787-9

EC Name:

Tetradecyl myristate

Cas Number:

3234-85-3

Molecular formula:

C28H56O2

IUPAC Name:

tetradecyl myristate

Constituent 3

Reference substance name:

112-72-1

Cas Number:

112-72-1

IUPAC Name:

112-72-1

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

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.