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Diss Factsheets
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EC number: 947-528-6 | CAS number: -
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(neodecanoyloxy)dioctylstannane
- EC Number:
- 269-595-4
- EC Name:
- Bis(neodecanoyloxy)dioctylstannane
- Cas Number:
- 68299-15-0
- Molecular formula:
- C36H72O4Sn
- IUPAC Name:
- Neodecanoic acid, 1,1'-(dioctylstannylene) ester
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
16JSVA015
- Expiration date of the lot/batch:
14. September 2018
- Purity test date:
not state
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room Temperature: (20 ± 5°C), keep container tightly closed, store under inert gas
- Stability under test conditions:
assumed stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Specification
Species Bos primigenius Taurus (fresh bovine corneas)
Origin
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr.
2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and
60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution
with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100
μg/mL) in a suitable cooled container. Then, the corneas were dissected and incubated in
medium at 32 ± 1 °C in an incubation chamber for 1 hour.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h post incubation, 90 min incubation with sodium fluorescein.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS
After the arrival of the corneas, they were examined and only corneas which were free
from damages were used. The corneas were excised with a scalpel and cut from the globe
with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea
holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders
were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
HBSS: Hank’s Balanced Salt Solution (HBSS) 10-fold concentrated, diluted in demin. water
(1:10)
SOLVENT CONTROL USED (if applicable)
not applicable
POSITIVE CONTROL USED
Dimethylformamide, DMF, CAS-No. 68-12-2, undiluted,
APPLICATION DOSE AND EXPOSURE TIME
750 µL, 10 min
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes, 2 h
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 1
- POST-EXPOSURE INCUBATION: 2h
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change of opacity value of each treated cornea with test item, positive control and
negative control was calculated by subtracting the initial basal opacity from the post treatment
opacity reading for each cornea.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used. yes
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of three replicates
- Value:
- ca. 2.13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- According to the guideline, the test is considered as valid if the positive control causes an
IVIS that falls within two standard deviations of the current historical mean.
The negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Parameter Criterion Found Assessment
IVIS of negative control HBSS ≤ 3 -0.64 ok
IVIS of positive control DMF undiluted 45.08 – 153.86 74.09 ok
Values for negative and positive controls were within the range of historical data of the test
facility. Therefore, the test was acceptable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item Bis(neodecanoyloxy)dioctylstannane showed no effects on the cornea of the bovine eye.
- Executive summary:
One valid experiment was performed.
Bovine corneas were used. They were collected from slaughtered cattle which were between
12 and 60 months old.
The test item Bis(neodecanoyloxy)dioctylstannane was brought onto the cornea of a bovine
eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour
and whose opacity had been measured.
The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of
the test item and 2 hours post-incubation, opacity and permeability values were measured.
HBSS-solution was used as negative control. The negative control showed no irritating
effect on the cornea and the calculated IVIS (in vitro irritancy score) is -0.64.
Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced
serious eye damage on the cornea and falls within two standard deviations of the
current historical mean. The calculated IVIS (in vitro irritancy score) is 74.09.
Under the conditions of this study, the test item Bis(neodecanoyloxy)dioctylstannane
showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy
score) is 2.13.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires
no classification for eye irritation or serious eye damage.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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