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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
pre-GLP, pre-OECD guideline, 50 µl amount of test substance, 8 days observation period.

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:
Method: 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 3h 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. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Substance name: 1-Methylimidazol (flüssig)
Substance number: XVI/41

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
8 d
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:
cornea opacity score
Basis:
other: animal #1 and #2
Time point:
other: 1 h - 24 h - 8 d
Score:
1 - 2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: cauterization at all time points
Irritation parameter:
conjunctivae score
Basis:
other: animal #1 and #2
Time point:
other: 8 d
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: cauterization at all time points
Irritation parameter:
chemosis score
Basis:
other: animal #1 and #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: cauterization at all time points
Irritation parameter:
iris score
Basis:
other: animal #1 and #2
Time point:
other: 24 h - 8 d
Score:
0
Max. score:
2
Remarks on result:
other: cauterization at all time points
Irritant / corrosive response data:
Cauterization of the mucous membrane was observed at all time points.

Applicant's summary and conclusion

Interpretation of results:
corrosive