Registration Dossier
Registration Dossier
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EC number: 245-912-1 | CAS number: 23850-94-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 May 1979 to 21 May 1979
- 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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane
- EC Number:
- 245-912-1
- EC Name:
- Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane
- Cas Number:
- 23850-94-4
- Molecular formula:
- C28H54O6Sn
- IUPAC Name:
- butyltris[(2-ethyl-1-oxohexyl)oxy]stannane
- Test material form:
- liquid
- Details on test material:
- - Appearance: clear liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 9 weeks old
- Housing: The animals were housed 2/cage in suspended wire mesh cages (30 x 18 x 18 ")
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 21°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Duration of treatment / exposure:
- - The lids were held together briefly to ensure adequate distribution of the test material.
- The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 7 males and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation of the test material with 20 mL warm tap water.
SCORING SYSTEM:
- The general health of the rabbits was monitored during the observation period.
- The ocular reactions of the cornea, iris, and conjunctiva were graded at 1, 2, 3, 4 and 7 days after dosing. The eyes were graded by the Draize scoring system. In determining a positive or negative irritation effect only those scores recorded on Days 1, 2 and 3 were considered.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Reactions were severe in 4/6 unwashed eyes and included opacities which cleared in all but one by Day 7.
Reactions were severe in 1/3 washed eyes (included opacity on Day 2). All positive scores were clear by Day 3.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU Criteria: Category 2 irritating to eyes
- Conclusions:
- Under the conditions of this study the test material was determined to be an eye irritant.
- Executive summary:
The potential of the test material to cause irritation to the eye was examined using rabbits according to a method similar to the standardised guideline OECD 405.
During the study, the test material (0.1 mL) was placed once into the conjunctival sac of one eye of each of nine rabbits. The lids were held together briefly to ensure adequate distribution of the test material. The untreated eye of each rabbit served as a control. The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation of the test material with 20 mL warm tap water.
Reactions to the test material were severe in 4/6 unwashed eyes and included opacities which cleared in all but one by Day 7. Reactions were severe in 1/3 washed eyes (included opacity on Day 2). All positive scores were clear by Day 3.
Under the conditions of this study the test material was determined to be an eye irritant.
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