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:
1966
Report Date:
1966

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:
BASF test. 50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Methylimidazol

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as control with talc powder.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 50 µl
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Cauterization of mucous membrane was observed from observation time period 1 hour and this was not reversible.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h - 24 h - 8d
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Cauterization of mucous membrane was observed from observation time period 1 hour and this was not reversible.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h - 24 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Cauterization of mucous membrane was observed from observation time period 1 hour and this was not reversible.
Irritant / corrosive response data:
Cauterization of mucous membrane was observed from observation time period 1 hour and this was not reversible.

Applicant's summary and conclusion