Registration Dossier
Registration Dossier
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EC number: 214-263-6 | CAS number: 1118-46-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February to April 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A single dose was administered followed by a 1 day observation period. Due to severe ocular irritation and tissue damage, the animals were sacrificed on day 1 for humane reasons.
- GLP compliance:
- no
Test material
- Reference substance name:
- N-butyltin trichloride
- EC Number:
- 214-263-6
- EC Name:
- N-butyltin trichloride
- Cas Number:
- 1118-46-3
- Molecular formula:
- C4H9Cl3Sn
- IUPAC Name:
- n-butyltin trichloride
- Test material form:
- liquid
- Details on test material:
- - Description: Clear light yellow liquid
- Date of receipt : april 7, 1988
- Storage : room temperature
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: at least 8 weeks
- Housing: Animals individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: municipal water ad libitum
- Acclimation period: 56 days
- No known contaminants that were reasonably expected in food or water that would interfere with the study.
- Animals considered unsuitable were excluded from selection for the study
ENVIRONMENTAL CONDITIONS
- Temperature: 60-70 °F
- Relative humidity of 30-70 %
- Photoperiod: 12-h light/dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Dose : 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1 day
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to the Draize scale
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 1h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: 1 rabbit with a score of 1, and one rabbit with a score of 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 1h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 4 rabbits with a score of 2 and 2 rabbits with a score of 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 1h
- Score:
- 2.17
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: 5 rabbits with a score of 2, one rabbit with a score of 3
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 1h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: All rabbits have a score of 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- (area)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 1h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: All rabbits have a score of 4
- Irritant / corrosive response data:
- The test material was corrosive to the eye. All six animals exhibited severe conjunctival and corneal tissue destruction. Due to the severe ocular response, all animals were sacrificed after the 1-hour observation for humane reasons.
Score of iritis cannot be calculated because of necrosis.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU Category 1
- Conclusions:
- Under the conditions of this study, the test material was corrosive to eyes.
- Executive summary:
The potential of the test material to cause irritation to the eye was investigated.
A single dose of the test material was administered into the eye of a rabbit, followed by a one day observation period.
The test material was corrosive to the eye. All six animals exhibited severe conjunctival and corneal tissue destruction. Due to the severe ocular response, all animals were sacrificed after the 1-hour observation for humane reasons.
Under the conditions of this study, the test material was corrosive to eyes.
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