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EC number: 239-581-2 | CAS number: 15535-79-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 February 2013 to 28 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to standardised guidelines OECD 405 and EU Method B.5 and in line with GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
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:
- 2,2-dioctyl-1,3,2-oxathiastannolan-5-one
- EC Number:
- 239-581-2
- EC Name:
- 2,2-dioctyl-1,3,2-oxathiastannolan-5-one
- Cas Number:
- 15535-79-2
- Molecular formula:
- C18H36O2SSn
- IUPAC Name:
- 2,2-dioctyl-1,3,2-oxathiastannolan-5-one
- Details on test material:
- - Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Hsdlf:NZW
- Sex: male.
- Age at study initiation: 12 - 20 weeks.
- Weight at study initiation: 2.40 - 2.66 kg.
- Housing: individually in suspended cages.
- Diet: rabbit diet provided ad libitum.
- Water: mains drinking water, ad libitum.
- Acclimation period: at least 5 days.
Immediately before the start of the test, both eyes of the test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
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 light / 12 hours dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contra lateral eye was used as an untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (98 mg). - 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 ocular responses and initial pain reaction 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 animals initially, followed by a further animal 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 1, 24, 48 and 72 hours following treatment were scored in accordance with the criteria of Draize (1977) and assessed using a modified form of the Kay and Calandra system (1962). Any other ocular effects were also noted.
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
ADDITIONAL OBSERVATIONS
Any clinical signs of toxicity, if present, were noted.
Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48 hour observations.
Both treated eyes appeared normal at the 72 hour observation.
The test material produced a maximum group mean score of 3.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. - Other effects:
- Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 3: Ocular Irritation Results
Parameter |
Animal |
Male 1 |
Male 2 |
||||||||
Time after treatment (hours) |
1 |
24 |
48 |
72 |
Mean* |
1 |
24 |
48 |
72 |
Mean* |
|
Cornea: |
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of cornea involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris: |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae: |
Redness |
1 |
1 |
1 |
0 |
0.66 |
1 |
1 |
1 |
0 |
0.66 |
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Mean at 24, 48 and 72 hours.
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 a GLP study which was conducted in accordance with standardised guidelines OECD 405 and EU Method B.5. During the study, 0.1 mL of test material was placed into one eye of each of two rabbits and was assessed for up to 72 hours to determine the grade of ocular reaction. No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48 hour observations. Both treated eyes 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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