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EC number: 268-500-3 | CAS number: 68109-88-6
- 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, other
- Remarks:
- According to OECD 405
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1982 to 25 October 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- The procedure was based upon the guideline but was not in every part identical.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The animals were not evaluated 60 minutes after exposure and the observation period lasted only 7 days.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- EC Number:
- 268-500-3
- EC Name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Cas Number:
- 68109-88-6
- Molecular formula:
- C28H48O8Sn
- IUPAC Name:
- ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Test material form:
- other: liquid that tends to crystallise
- Details on test material:
- - Appearance: clear liquid, tends to crystallise
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day.
IN-LIFE DATES: From: 18 October 1982 To: 25 October 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each animal remained untreated and served as concurrent control.
- Amount / concentration applied:
- - Volume: 0.1 mL
- Duration of treatment / exposure:
- After insertion of the test material into the conjunctival sac, the eyelids were gently closed for 15 seconds.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 9; 6 male and 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of the 9 rabbits the eye was flushed with 10 mL of sterile physiological saline
- Time after start of exposure: approximately 30 seconds after treatment
SCORING SYSTEM:
- Eyes were scored according to the Draize scale (1977)
TOOL USED TO ASSESS SCORE: slit-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: PII
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 29.6
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- other: PII
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 22.1
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritant / corrosive response data:
- The test material was found to cause moderate irritation.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Table 1 Calculation of Primary Eye Irritation Index
Time After Exposure | Mean Reaction Score | |||||
Unrinsed Eyes | Rinsed Eyes | |||||
Cornea | Iris | Conjunctiva | Cornea | Iris | Conjunctiva | |
24 hrs | 11.7 | 2.5 | 17.0 | 10.0 | 0.0 | 16.0 |
48 hrs | 13.3 | 2.5 | 16.7 | 10.0 | 0.0 | 18.0 |
72 hrs | 14.2 | 2.5 | 16.7 | 10.0 | 0.0 | 15.3 |
4 days | 14.2 | 2.5 | 14.0 | 8.3 | 0.0 | 10.0 |
7 days | 10.0 | 1.7 | 8.7 | 6.7 | 0.0 | 6.0 |
Subtotal | 63.4 | 11.7 | 73.1 | 45.0 | 0.0 | 65.3 |
Total | 148.2 | 110.3 | ||||
PII | 29.6 | 22.1 |
Table 2 Individual Irritation Scores at 24, 48, 72 hours and days 4 and 7
Unrinsed | Rinsed | |||||||||||
Observation Time | Observation | Male 1 | Male 2 | Male 3 | Female 1 | Female 2 | Female 3 | Average | Male 4 | Male 5 | Male 6 | Average |
24 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
Conjunctivae | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | 3 | 3 | 3 | 3.0 | |
Chemosis | 3 | 3 | 3 | 3 | 3 | 2 | 2.8 | 3 | 2 | 3 | 2.7 | |
48 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
Conjunctivae | 3 | 3 | 3 | 3 | 3 | 2 | 2.8 | 3 | 3 | 3 | 3.0 | |
Chemosis | 3 | 3 | 3 | 3 | 3 | 1 | 2.7 | 3 | 3 | 3 | 3.0 | |
72 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
Conjunctivae | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | 3 | 3 | 3 | 3.0 | |
Chemosis | 3 | 3 | 3 | 2 | 3 | 3 | 2.8 | 3 | 2 | 2 | 2.3 | |
4 days | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
Iris | 1 | 0 | 1 | 0 | 1 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
Conjunctivae | 3 | 3 | 2 | 3 | 3 | 3 | 2.8 | 2 | 2 | 2 | 2.0 | |
Chemosis | 2 | 2 | 2 | 2 | 2 | 3 | 2.2 | 2 | 2 | 2 | 2.0 | |
7 days | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
Iris | 1 | 0 | 1 | 0 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0.0 | |
Conjunctivae | 2 | 1 | 2 | 2 | 2 | 1 | 1.7 | 1 | 2 | 1 | 1.3 | |
Chemosis | 2 | 1 | 2 | 2 | 2 | 1 | 1.7 | 1 | 1 | 1 | 1.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified as Category 2 according to EU criteria.
- Conclusions:
- Under the conditions of the test, the test material was shown to be irritating to the eyes. In accordance with EU criteria the test material is classified as Category 2.
- Executive summary:
The eye irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.
Nine New Zealand White rabbits were exposed to the test material; the treated eye of three animals was rinsed with saline 30 seconds after exposure. The reactions to the test material were evaluated in accordance with the Draize scale (1977) after 24, 48 and 72 hours followed by further observations after 4 and 7 days. The test material was determined to cause moderate irritation.
Under the conditions of this study, the test material was shown to cause irritation to the eye which would require classification under regulation directive 1272/2008. The test material requires classification as "Category 2, H319: Causes serious eye irritation" with signal word "Warning".
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