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EC number: 236-406-1 | CAS number: 13355-96-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- 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:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Young albino rabbits of the New Zealand strain were used to evaluate the eye irritating properties of the test material. The test method was patterned after that of Draize, et al.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
Test material
- Reference substance name:
- Butylhydroxyoxostannane
- EC Number:
- 218-880-1
- EC Name:
- Butylhydroxyoxostannane
- Cas Number:
- 2273-43-0
- Molecular formula:
- C4H10O2Sn
- IUPAC Name:
- butyl(oxo)stannanol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white powder
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: young
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (40 mg) test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of the animal served as a control. - Observation period (in vivo):
- 1, 24, 48 and 72 hours and 7 days.
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing
SCORING SYSTEM:
- At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.
- The maximum possible score was 110 points, which indicated maximal irritation and damage to all 3 ocular tissues. Zero score indicated no irritation.
- In this scoring system, special emphasis was placed upon irritation or damage to the cornea, while less emphasis was placed upon damage to the iris and conjunctiva.
- The criteria used for assignment of the classification was the frequency, the extent and the persistence of irritation or damage which occurred to the 3 ocular tissues. The classification was obtained by selecting the maximum mean irritation score at 1, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury did not meet the requirements defined for the classification appropriate for a particular numerical score, the classification was raised by 1 or more levels.
CORNEA
- Opacity (D) Degree of density (area which is most dense is taken for reading):
Scattered or diffuse area, details of iris clearly visible = 1
Easily discernible, translucent areas, details of iris slightly obscured = 2
Opalescent areas, no details of iris visible, size of pupil barely discernible = 3
Opaque, iris invisible = 4
- Area of cornea involved (A):
One quarter (or less) but not 0 = 1
Greater than one quarter but less than one half = 2
Greater than one half but less than three quarters = 3
Greater than three quarters to whole area = 4
Score equals D x A x 5
Total maximum = 30
IRIS
- Values:
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or a combination of any thereof), iris still reacting to light (sluggish reaction is positive) = 1
No reaction to light, haemorrhage, gross destruction (any or all of these) =2
Score equals value x 5
Total maximum = 10
CONJUNCTIVAE
- Redness (R) (refers to palpebral conjunctiva only):
Vessels definitely injected above normal = 1
More diffuse, deeper crimson red; individual vessels not easily discernible = 2
Diffuse, beefy red = 3
- Chemosis (S):
Any swelling above normal (includes nictitating membrane) = 1
Obvious swelling with partial eversion of the lids = 2
Swelling with lids about half-closed = 3
Swelling with lids about half-closed to completely closed = 4
- Discharge (D):
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) = 1
Discharge with moistening of the lids and hairs just adjacent to the lids = 2
Discharge with moistening of the lids and hairs and considerable area around the eye = 3
Score (R + S + D) x 2
Total maximum = 20
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 5
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: redness, chemosis and discharge combined to give conjunctivae score
Any other information on results incl. tables
Table 1: Summary of Results
Tissue |
Rabbit Number |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
Cornea (D-A) |
1 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
5 |
0 |
0 |
0 |
|
Conjunctivae (R-S-D) |
4 (2-0-0) |
4 (2-0-0) |
2 (1-0-0) |
0 |
0 |
|
Total |
4 |
9 |
2 |
0 |
0 |
|
Cornea (D-A) |
2 |
5(1-1) |
0 |
0 |
0 |
0 |
Iris |
0 |
5 |
0 |
0 |
0 |
|
Conjunctivae (R-S-D) |
4 (2-0-0) |
4 (2-0-0) |
0 |
0 |
0 |
|
Total |
9 |
9 |
0 |
0 |
0 |
|
Cornea (D-A) |
3 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae (R-S-D) |
4 (1-1-0) |
2 (1-0-0) |
0 |
0 |
0 |
|
Total |
4 |
2 |
0 |
0 |
0 |
|
Cornea |
Average |
1.7 |
0.0 |
0.0 |
0.0 |
0.0 |
Iris |
0.0 |
3.3 |
0.0 |
0.0 |
0.0 |
|
Conjunctivae |
4.0 |
3.3 |
0.7 |
0.0 |
0.0 |
|
Total |
5.7 |
6.6 |
0.7 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU Criteria
- Conclusions:
- Under the conditions of this study the test material was not irritating to the eyes.
- Executive summary:
The eye irritation potential of the test material was investigated using New Zealand white rabbits.
The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.
Under the conditions of this study the test material was not irritating to the eyes.
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