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Toxicological information

Eye irritation

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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:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
not specified
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 / 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.