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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
Study period:
1988
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium bromide
EC Number:
231-599-9
EC Name:
Sodium bromide
Cas Number:
7647-15-6
Molecular formula:
NaBr
IUPAC Name:
Active bromine generated from sodium bromide and sodium hypochlorite
Details on test material:
Sodium bromide
Lot 7320
Purity 99.23 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: approximately 13-16 weeks
- Weight at study initiation: 3-3.7 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 94 other: mg

Duration of treatment / exposure:
unspecified: following instillation of the test material, the treated eye remained unwashed throughout the entire observation period.

Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 males
Details on study design:
Comment: not rinsed

SCORING SYSTEM:
Scoring system similar to description in OECD guideline No. 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 60-168 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 60-168 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
0.56
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
discharge
Basis:
mean
Time point:
other: 24-72 h
Score:
1.5
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.6
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Mild conjunctival irritation in all six animals, three of these animals showed obvious swelling with partial eversion of the lids.
Other effects:
no further details

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observations made on the eyes in all individual animals and considering the provisions laid down in CLP Regulation (EC) No 1272/2008 for the assessment of the eye irritancy of a substance, sodium bromide is not regarded to be ´irritating` to the eyes of rabbits. No classification and labelling with respect to eye irritancy is, therefore, required

Executive summary:

94 Milligrams of the test substance was applied to one eye of each of 6 male rabbits and held in place for 1 second in each case. Observations of the resulting eye condition were made 60 minutes after test substance application, and again after 1, 2, 3, 4 and 7 days. Average scores (for days 1 to 3): cornea – 0; iris – 0; conjunctiva redness – 0.56, chemosis – 0.6 and discharge – 1.5. All irritant effects observed were reversed within 1 to 3 days.

The substance is classed as ‘slightly irritating’ under the classification system used in the study.