Registration Dossier

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report Date:
1958

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The test substance was applied as powder (0.1 g) into the right eyes of 2 rabbits, the left eye was treated with physiological saline solution for comparison. The observation period was 10 days.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: saline-treated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

Results and discussion

In vivo

Results
Irritation parameter:
other: observations regarding eye irritation
Basis:
other: observations in individual animals
Remarks on result:
other: Findings: on day of treatment: redness and discharge in 2/2; day 2: redness in 1/2, discharge and slight opacity in 1/2; day 3: redness and chemosis in 1/2; day 6: complete reversibility

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria