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:
other: Basic data given
Remarks:
(no details on study design and results provided)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To evaluate the irritation potential towards the eyes, 0.1 mL test substance was instilled into the eyes of six rabbits for 1 min and 24 hrs. Irritation was determined at 1,24, 48, 72, 120 and 168 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: KL1003

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
1 min and 24 h
Observation period (in vivo):
7 days
Reading time points: 1 min, 1, 24, 48, 72, 120 and 168 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cornea
Basis:
animal: 1-6
Time point:
other: 1 min and 24 h
Reversibility:
not reversible
Remarks on result:
other: corrosive within 1 min
Irritation parameter:
other: iris
Basis:
animal: 1-6
Time point:
other: 1 min and 24 h
Reversibility:
not reversible
Remarks on result:
other: corrosive within 1 min
Irritation parameter:
other: conjuncitvae
Basis:
animal: 1-6
Time point:
other: 1 min and 24 h
Reversibility:
not reversible
Remarks on result:
other: corrosive within 1 min
Irritant / corrosive response data:
The undiluted test substance was corrosive within 1 minute after instillation.
Other effects:
- Other observations: Severe discomfort was observed after test substance instillation.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
CLP: Category 1