Registration Dossier
Registration Dossier
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EC number: 232-152-0 | CAS number: 7789-24-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- HYPOTHESIS FOR THE ANALOGUE APPROACH
Lithium fluoride completely dissociates in water forming lithium cation and the corresponding fluoride anion. Thus, lithium salts with different anion moieties and fluoride compounds were found to be suitable candidates for read-across. (Eco)toxicological properties were extrapolated to different endpoints by using the lowest effect concentration.
For further information, please refer to the read-across justification in IUCLID, section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1988-01-20 to 1988-02-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The study was conducted with four instead of three animals. The eyes of two of them were washed with water shortly after instillation. The treated eye of the other two animals remained unwashed.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.: FMC-T 595
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: very hygroscopic. Kept tightly sealed. - 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 - 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. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- positive indication of irritation
- 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.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test material was considered to be irritating to both washed and unwashed eyes.
- Executive summary:
An eye irritation/corrosion study with lithium fluoride is not available. Consequently, read-across was applied using a characteristically similar compound, lithium bromide.
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)
Data source
Materials and methods
Test material
- Reference substance name:
- Lithium fluoride
- EC Number:
- 232-152-0
- EC Name:
- Lithium fluoride
- Cas Number:
- 7789-24-4
- Molecular formula:
- FLi
- IUPAC Name:
- lithium(1+) fluoride
- Test material form:
- solid
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- eye washed
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on LiBr (I87-1000,1988)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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