Lithium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-21 to 1988-03-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium chloride

EC Number:

231-212-3

EC Name:

Lithium chloride

Cas Number:

7447-41-8

Molecular formula:

ClLi

IUPAC Name:

lithium chloride

Test material form:

solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable

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
- Age at study initiation: Young adult
- Weight at study initiation: 3.09 kg to 3.44 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum, Purina High Fiber Rabbit Chow 5326
- Water: ad libitum, fresh tap water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C - 21.7°C
- Humidity: 28 % - 59 %
- Photoperiod: 12 hours fluorescent light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per test eye

Duration of treatment / exposure:

The test material was tapped off a piece of weighing paper into the lower conjunctival sac which was formed when the lower eyelid was pulled away from the test eye. The upper and lower lids were then brought together and held closed for one second and released. The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 ml of tap water approximately 20 - 30 sec after treatment.

Observation period (in vivo):

The animals were weighed once on the day before dosing. Clinical signs were recorded as noted.

Number of animals or in vitro replicates:

4 (1 male, 3 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 sec after treatment. The rate of application of the wash water was approximately 100 mL/min.
- Time after start of exposure: 20 - 30 sec

SCORING SYSTEM: The eyes were scored for irritation potential at 1, 24, 48 and 72 hours and on day 4, 7, 10, 13 and 16 using the method of Draize.

TOOL USED TO ASSESS SCORE: After the 24 hour examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

washed eye

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #4

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 13

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #4

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day7

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

washed eye

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

chemosis score

Basis:

animal #4

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

One hour post-dosing, slight to mild corneal opacities, iritis and severe conjunctivitis were noted in all eyes. At the 48-hour scoring, mild opacities and moderate conjunctivitis were observed; one animal also had hemorrhagic conjunctivae and one had brown areas on the conjunctivae. By day 7, washed eyes had recovered, unwashed eyes had mild conjunctivitis, one of which had white, brown and hemorrhagic areas on the conjunctivae. Unwashed eyes recovered by day 16, at which time the test was terminated. Washing the eyes with tap water shortly after exposure decreased the duration of the irritation observed.

Other effects:

The mean body weight of the animals was 3.25 ± 0.145 kg on the day prior to dosing.
All animals remained healthy throughout the study.

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of this study, the test material is irritating to eyes.

Executive summary:

An acute eye irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 405. Lithium Chloride Anhydrous Technical was instilled into the test eyes of 4 New Zealand White rabbits at a dose of 0.1 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 1, 24, 48 and 72 hours after installation, as well as on days 4, 7, 10, 13 and 16.

Slight to mild corneal opacities, iritis and moderate to severe conjunctivitis was noted in both washed and unwashed eyes during the study. White, brown and hemorrhagic areas were noted on the conjunctivae of two rabbits. Irritation was greatest 1 -hour after dosing, then gradually subsided. Washed eyes recovered by day 7, and unwashed eyes recovered by day 16. Washing the eyes with tap water shortly after exposure decreased the duration of the irritation observed.

The used scores of the US scheme were adapted to the EU scheme.