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Diss Factsheets

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:
1988-01-20 to 1988-02-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study with slight deviations to the correspondent OECD guideline.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Please refer to the section "Principles of method if other than guideline"
Principles of method if other than guideline:
The study was conducted with four instead of three animals. The eyes of two of them were washed with water shortly after the instillation. The other two animals remained unwashed.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium bromide
EC Number:
231-439-8
EC Name:
Lithium bromide
Cas Number:
7550-35-8
Molecular formula:
BrLi
IUPAC Name:
lithium bromide
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania, USA
- Age at study initiation: young adults
- Weight at study initiation: 3.10 - 3.24 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 71
- Humidity (%): 29 - 59
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left untreated eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
20-30 seconds
Observation period (in vivo):
16 days
Number of animals or in vitro replicates:
four animals (three males, one female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Washing was done with fresh tap water in two out of four animals. The other two remained unwashed.
- Time after start of exposure: 20-30 seconds

SCORING SYSTEM: Draize, J.H. et al. (1944)

TOOL USED TO ASSESS SCORE: The eyes were assessed with a penlight type lamp as well as with the aid of 2 % sodium fluorescein dye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye not washed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye not washed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye washed with tap water
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye washed with tap water
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye not washed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye not washed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye washed with tap water
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye washed with tap water
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye not washed
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye not washed
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye washed with tap water
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: eye washed with tap water
Irritant / corrosive response data:
One hours post-dosing, mild to severe conjunctivitis and slight corneal opacities were noted. Irritation worsened after 24 hours at which time one eye also developed a hemorrhagic conjunctivae and one eye had a white conjunctivae. After 48 hours, irritation gradually subsided and was completely resolved by study day 16. Washing the eyes with tap water shortly after exposure increased the severity of the irritation observed.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this study, the test material was considered to be not irritating to both washed and unwashed eyes.
Executive summary:

An eye irritation study was conducted with lithium bromide anhydrous according to a non-definitive eye irritation protocol from FMC. Lithium bromide anhydrous was instilled into the test eyes of four New Zealand White rabbits at a dose of 0.10 g. The eyes of two rabbits remained unwashed while the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 seconds after treatment. Eyes were assessed for irritation using the method of Draize at 24, 48 and 72 hours after instillation.

Mild to severe conjunctivitis and slight to mild corneal opacities were noted during the study. In addition, white, brown and hemorrhagic areas were noted on the conjunctivae. All irritation resolved by study day 16, at which the test was terminated. Washing the eyes with tap water shortly after exposure increased the severity of the irritation observed. One rabbit (with washed eyes) developed significantly higher scores regarding cornea opacity (2), conjunctival redness (2.33) and chemosis (3.67) compared to the other three animals. Due to the facts it can not be totally excluded that lithium bromide is irritating.

Considering the results of this study, lithium bromide anhydrous is considered to be irritating to the eyes of New Zealand White rabbits. (FMC, 1988)