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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
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, short report but giving all major details, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: Federal Register Vol. 38, Nr. 187, S. 27019, 1973
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 0.9% saline
- 24 hours after application


SCORING SYSTEM: Federal Register Vol. 38, Nr. 187, S. 27019, 1973
"Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, S. 51, 1975

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

Results of in vivo study
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 h
Score:
12
Max. score:
12
Irritant / corrosive response data:
The slight, transient effects recorded in this study cause by application of the dry powder were considered as mechanical irritation by solid grains of the test material.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, S. 51, 1975
Conclusions:
The test item was found to be sligthly irritant to eyes (powder effect)
Executive summary:

Six rabbits were emploeyed to determine the effects of the test item on the mucous membranes of the eye. 100 mg try powder were applied per eye to the conjunctival sac. The left eye was treated the right served as control. The test war performed according to Federal Register Vol. 38, Nr. 187, S. 27019, 1973.

Observations ere recorded 1, 7, 24, 48 and 72 hours after application using a magnifying lens. After observation at 24 hours all eyes were washed using saline. Observations at 48 and 72 hours were made after instillation of sodium fluorescin solution (0.01%).

Effects wwere scored according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, S. 51, 1975.

Result:

After application of the dry powder the maximum irritation index of 12 was observed after 7 hours.

The slight, transient effects recorded in this study cause by application of the try powder were considered as mechanical irritation by solid grains of the test material.