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EC number: 222-883-3 | CAS number: 3648-18-8
- 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
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- Endpoint summary
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- 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
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 November 2012 to 22 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dioctyltin dilaurate
- EC Number:
- 222-883-3
- EC Name:
- Dioctyltin dilaurate
- Cas Number:
- 3648-18-8
- Molecular formula:
- C40-H80-O4-Sn
- IUPAC Name:
- dioctyltin dilaurate
- Test material form:
- other: liquid (undefined)
- Details on test material:
- Storage: Room temperature in the dark.
State: Yellow liquid.
pH: Determined to be 6.8.
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: 12 - 20 weeks
- Weight at study initiation: 2.53 - 2.59 kg
- Housing: individually in suspended cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From 12 November 2012 - 22 November 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- - Dose administration: 0.1 mL of the test material was placed into the conjunctival sac of the right eye of one rabbit by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were then held together for about 1 second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. After consideration of the initial pain reaction (see Table 2) in the first treated animal, a second animal was treated.
- Observation period (in vivo):
- Animals were observed up to 72 hours post administration.
- Number of animals or in vitro replicates:
- One male initially, followed by a further male once the irritation potential was fully assessed in the first animal.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Washing: Irrigation was not performed.
SCORING SYSTEM:
The reactions observed were scored in accordance with the criteria of Draize (1977).
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Mean at 24, 48 and 72 hours
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 24 hour observation and persisted in one treated eye at the 48 hour observation. One treated eye appeared normal at the 48 hour observation and the other treated eye appeared normal at the 72 hour observation.
- Other effects:
- Both animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 3: Results
Animal |
No. 1 |
No. 2 |
||||||
Time after treatment |
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
Cornea |
||||||||
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of cornea involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
||||||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
||||||||
Redness |
2 |
1 |
1 |
0 |
2 |
1 |
0 |
0 |
Chemosis |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Individual total scores |
10 |
4 |
2 |
0 |
10 |
4 |
0 |
0 |
Initial pain reaction: When the test material was instilled in the eye, the animals were observed to blink a few times within one or two minutes. The initial pain reaction of 1 was given to each animal tested.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.
- Executive summary:
The eye irritation potential of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5, in vivo. During the study, 0.1 mL of test material was placed into one eye of each of two rabbits and assessed for up to 72 hours to determine the grade of ocular reaction. No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 24 hour observation and persisted in one treated eye at the 48 hour observation. One treated eye appeared normal at the 48 hour observation and the other treated eye appeared normal at the 72 hour observation. Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.
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