Dibromomethane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted prior to availability of the appropriate OECD and OPPTS testing guidelines. However, the study was well documented and is scientifically acceptable. Hence, it was identified as a key study and was graded klimisch 2.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Rabbits were inoculated with DBM in the eye. Examinations for signs of irritation or injury were made at intervals of 1, 2, 4, 8, 24, 48 and 72 hours after the rabbits were exposed to the test material. Scoring was performed according to Draize procedure.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibromomethane

EC Number:

200-824-2

EC Name:

Dibromomethane

Cas Number:

74-95-3

Molecular formula:

CH2Br2

IUPAC Name:

dibromomethane

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No further information

Test system

Controls:

other: The contralateral eye served as control.

Amount / concentration applied:

0.1 ml (3 drops) of the test material (unspecified purity, DBM) in the eye.

Observation period (in vivo):

Examinations for signs of irritation or injury were made at intervals of 1, 2, 4, 8, 24, 48 and 72 hours after the rabbits were exposed to the test material.

Number of animals or in vitro replicates:

Six New Zealand White (NZW) rabbits

Details on study design:

Six New Zealand White (NZW) rabbits were inoculated with 0.1 ml (3 drops) of the test material (unspecified purity, DBM) in the eye. The tested rabbits were free of any pre-test ocular abnormalities. The contralateral eye served as control. Examinations for signs of irritation or injury were made at intervals of 1, 2, 4, 8, 24, 48 and 72 hours after the rabbits were exposed to the test material. Scoring was performed according to Draize procedure.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Remarks on result:

other: moderate eye irritation

Irritant / corrosive response data:

Immediately following the introduction of DBM into the conjunctive sac, the eye closed and the rabbit rubbed the eye with a foot. After several minutes the rubbing stopped. Within 8 hours a capillary congestion and edema of the third eyelid developed.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information

Conclusions:

DBM caused moderate eye irritation which lasted 3 days or more following inoculation.

Executive summary:

Six New Zealand White (NZW) rabbits were inoculated with 0.1 ml (3 drops) of the test material (unspecified purity, DBM) in the eye. The tested rabbits were free of any pre-test ocular abnormalities. The contralateral eye served as control. Examinations for signs of irritation or injury were made at intervals of 1, 2, 4, 8, 24, 48 and 72 hours after the rabbits were exposed to the test material. Scoring was performed according to Draize procedure.

Immediately following the introduction of DBM into the conjunctive sac, the eye closed and the rabbit rubbed the eye with a foot. After several minutes the rubbing stopped. Within 8 hours a capillary congestion and edema of the third eyelid developed. DBM caused moderate eye irritation which lasted 3 days or more following inoculation.