Registration Dossier

Administrative data

Description of key information

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 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:
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.