Tetradecyl laurate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No details

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

A group of 6 albino rabbits was used in this study to determine the toxicity of the substance submitted, to eye musoca.

Vehicle:

other: corn oil

Controls:

not required

Amount / concentration applied:

Material was tested as a freshly prepared 15% solution in corn oil. One tenth of a milliliter of the product under test was instilled into the conjunctiva! sacs of the test animals. All the treated eyes remained unwashed.

Observation period (in vivo):

The evaluations were performed at one, twenty-four, etc. hours until seven days had elapsed. A 2% instillation of fluorescein was made on each animal at least once, during the course of the experimental period.

Number of animals or in vitro replicates:

6

Details on study design:

The test material was allowed to fall on the everted lower lid of each rabbit, the upper and lower lids were then gently held together for one second before releasing to prevent loss of material. Macroscopic readings were facilitated with microscopic readings (slit lamp examinations). A preparation eliciting corneal and iris lesions, which had not cleared by the seventh day were considered to be a severe eye irritant. The cornea was scored on the basis of the density of the opacity and the total area involved. The iris was scored on the intensity or degree of inflammation exhibited; and the palpebral and bulbar mucosae were scored on the extent of chemosis, hyperemia and discharge.

Irritation parameter:

overall irritation score

Basis:

other: total

Time point:

other: up to 7 days

Score:

34

Max. score:

110

Reversibility:

fully reversible

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

Does not require labeling for eye irritancy under the Federal Hazardous Substances Act.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

This dossier includes skin and eye irritation studies with the analogue tetradecyl myristate and a combination of tetradecyl myristate and laurate. Results showed only a mild irrtation of the skin or the eye, which was fully reversible. Hence, tetradecyl laurate should not be classified as either skin or eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
Study performed with a product containing approximately 90% of tetradecyl myristate and laurate.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The results of the studies present in this dossier failed to show that fatty alkyl esters meet the CLP classification criteria for irritancy to skin or eyes.