Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 31, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, no specific methodology followed although documented report available.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Nine (9) albino New Zealand rabbits without ocular defects were used. The procedure followed was a modification of that suggested by Dr. J.H. Draize in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration – Department of Health, Education and Welfare.

In the technique of determining toxicity of substances to eye mucosa, observation of injuries were made on the cornea, iris and the bulbar and palpebral conjunctivae. Numerical scores were assigned to lesions observed according to a standard scoring system. In this system of scoring, the injuries to the cornea and iris account for approximately eighty (80%) percent of the score; these structures are purposely weighted because of their vital role in vision. Healthy New Zealand rabbits were used for this test. One-tenth of a milliliter of the test substance was instilled in the right eye; the left eye, remaining untreated, served as a control.

The treated eyes of six rabbits remained unwashed for 24 hours. The eyes of the remaining three (3) rabbits were irrigated 4 seconds following instillation of the test material (30 ml tap water at 37 degrees C). Irrigation is important to determine the effect of washout, either beneficial or detrimental and the extent of that effect.

Readings facilitated by hand-held lenses were made 1, 2, 3, and up to 7 days after treatment.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Kronitex TCP (tricresyl phosphate)
IUPAC Name:
Kronitex TCP (tricresyl phosphate)
Details on test material:
- Name of test material (as cited in study report): Kronitex TCP (tricresyl phosphate)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): see Fig. no
- Substance type: not specified
- Physical state: not specified
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
Nine (9) albino New Zealand rabbits without ocular defects were used. All animals are fed and watered ad libitum; with Wayne animal feeds used
exclusively. Animals are received from Summit View Farm, Belvidere, New Jersey and are conditioned prior to use.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Second eye of each test organism served as the control.
Amount / concentration applied:
0.1 ml single application
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1,2,3,4 and up to 7 days after treatment
Number of animals or in vitro replicates:
9
Details on study design:
Nine (9) albino New Zealand rabbits without ocular defects were used. The procedure followed was a modification of that suggested by Dr. J.H. Draize in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration - Department of Health, Education and Welfare. In the technique of determining toxicity ofsubstances to eye mucosa, observation of injuries were made on the cornea, iris and the bulbar and palpebral conjunctivae. Numerical scores were assigned to lesions observed according to a
standard scoring system. In this system of scoring, the injuries to the cornea and iris account for approximately eighty (80%) percent of the score; these structures are purposely weighted because of their vital role in vision.
Healthy New Zealand rabbits were used for this test. One-tenth of a milliliter of the test substance was instilled in the right eye; the left eye, remaining untreated, served as a control. The treated eyes of six rabbits remained unwashed for 24 hours. The eyes of the remaining three (3) rabbits were irrigated 4 seconds following instillation of the test material (30 ml tap water at 37 degrees C). Irrigation is important to determine the effect of washout, either beneficial or detrimental and the extent of that effect. Readings facilitated by hand-held lenses were made 1, 2, 3, and up to 7 days after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Draize score
Basis:
mean
Time point:
other: 24 hours
Score:
0.7
Max. score:
1
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
0.3
Max. score:
1
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Minimal irritancy observed.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ocular instillation of 0.1 ml test substance into rabbit eyes was non-irritating (<1.0 / 110 Draize Score) with or without a 4 sec washout.
Executive summary:

Kronitex TCP was tested for occular irritation in rabbits and was found to be a non-irritant. No classification is applicable.

Categories Display