1,2-dimethylimidazole

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

prior to the adoption of OECD405 in 1981

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

Test material information

Constituent 1

Reference substance name:

1,2-dimethylimidazole

EC Number:

217-101-2

EC Name:

1,2-dimethylimidazole

Cas Number:

1739-84-0

Molecular formula:

C5H8N2

IUPAC Name:

1,2-dimethyl-1H-imidazole

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

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 7

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal 1-2

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Mucosal bleeding

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) based on GHS criteria