Tetradecyl laurate

Eye irritation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

not specified

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 / tissue source

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.

Test system

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.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: total

Time point:

other: up to 7 days

Score:

34

Max. score:

110

Reversibility:

fully reversible

Applicant's summary and conclusion

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.