Calcium bromide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium bromide

EC Number:

232-164-6

EC Name:

Calcium bromide

Cas Number:

7789-41-5

Molecular formula:

CaBr2

IUPAC Name:

calcium bromide

Details on test material:

White powder, stored at room temperature over silica gel.
For the purpose of this study the test material was used as supplied.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animal was housed in a suspended metal cage. Free access to mains drinking water and food was allowed throughout the study. The animal room was maintained at a temperature of 17-20C and relative humidity of 56-66%. The rate of air exchange was approximately 15 changes per hour and the lightning was controlled by a time switch to give 12 hours light and 12 hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated.

Amount / concentration applied:

A volume of 0.1 ml of test material, which was found to weigh approximately 89.7 mg was used.

Duration of treatment / exposure:

Single instillation of 0.1 ml test substance; eyes were unwashed for 24 hours.

Observation period (in vivo):

1 and 24 hours

Number of animals or in vitro replicates:

1

Details on study design:

No further details

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Time point:

other: 1 hour

Score:

41

Results 2

Irritation parameter:

overall irritation score

Time point:

other: 24 hours

Score:

61

Irritant / corrosive response data:

No further details

Other effects:

Transcluent corneal opacity, iridial inflammation, severe conjubctival irritation and sloughing of the cornea with petechial haemorrhage of the lower conjunctival membrane and an area of possible necrosis over this area and the nictitating membrane were noted in the treated eye at the 1 and 24-hour observations.
A blood stained discharge was noted at the 24-hour observation and the animal was killed for humane reasons in accordance with current UK Government Home Office guidelines and Safepharm Company policy.

Any other information on results incl. tables

No further details

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, calcium bromide, produced a maximum total score of 61.0 and was considered to be at least a severe irritant (class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on rabbit only).
The test material produces positive criteria in the treated rabbit according to EU labeling regulations and was considered to be IRRITANT to the rabbit eye. It is reasonable to assume the symbol "Xi" and highest risk phrase R 41 "risk of serious damage to the eyes" are therefore required.