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:
comparable to guideline study with acceptable restrictions
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

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
Details on test material:
- Name of test material (as cited in study report): 1,2-Dimethylimidazol
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 2.92 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: talc powder in the left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Remarks on result:
other: white crusts were formed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
2
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 8 d
Score:
1
Max. score:
4
Irritant / corrosive response data:
After 8 days, scarring of the eyelids was observed. During the whole observation period, hemorrhage of mucous membranes was observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information