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EC number: 500-336-2 | CAS number: 157348-58-8
- 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
- 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:
- 2016-05-26 to 2016-06-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted October 02, 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid
- EC Number:
- 500-336-2
- EC Name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid
- Cas Number:
- 157348-58-8
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and phosphorous acid
- Test material form:
- other: Colourless, viscous liquid
- Details on test material:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid manufactured by Evonik Degussa GmbH, Batch 1524201 of 2015-12-22.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Species / Strain: Rabbit / New Zealand White
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Sex: male
- Age: Approx. 3 months
- Weight at study initiation: Animal no. 1: 2.6 kg
- Housing: single
- Diet: ad libitum, Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany,
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animal, left eye
- Amount / concentration applied:
- Amount: 0.1 mL of the test item was administered to the right eye of one animal.
- Duration of treatment / exposure:
- Single administration into the conjunctival sac of the right eye
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 1 male rabbit
- Details on study design:
- ADMINISTRATION:
The test was performed initially using one animal. Due to the severe findings on cornea, iris and conjunctiva the test was stopped 24 hours after instillation. No further animal was employed.
0.1 mL of the test item was administered to the right eye of one animal.
The test item was placed into the conjunctival sac of the right eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material.
The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: test item was not rinsed
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE:
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1 and 24 hours after the administration.
The eye reactions were observed and registered.
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 2
- Remarks on result:
- other: not evaluable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Irritant / corrosive response data:
- SCORE
- Cornea: 4
- Iris: not evaluable - no examination
- Conjunctivae (Redness): 2
- Conjunctivae (Chemosis): 4 - Other effects:
- no other effects
Any other information on results incl. tables
Examination of the treated eye
Time after administration |
C O R N E A |
I R I S |
C O N J U N C T I V A E |
F L U O R E S C E I N T E S T |
||
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Opacity |
|
Redness#1 |
Chemosis#2 |
Grade |
Area |
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A n i m a l n o. : 1 |
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right eye: 0.1 mLTest item/animal |
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before dosing |
0 |
0 |
0 |
0 |
0 |
0 |
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60 minutes |
3 |
#3 |
3 |
3 |
- |
- |
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24 hours |
4 |
#3 |
2 |
4 |
4 |
4 |
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#1 refers to palpebral and bulbar conjunctivae; excluding cornea and iris
#2 swelling: refers to lids and/or nictitating membrane
#3 not evaluable
- no examination
Applicant's summary and conclusion
- Conclusions:
- The test substance causes irreversible damage to eyes in a study according to OECD 405 in rabbits.
- Executive summary:
The purpose of this study was to obtain information on the influence of test item on rabbit eyes (irritation/corrosion test).
Under the present test conditions, a single instillation of 0.1 mL test item into the conjunctival sac of the right eye of one rabbit caused the following effects:
Corneal opacity was observed at 60 minutes (grade 3) and 24 hours (grade 4) after instillation.
The fluorescein test revealed corneal staining (whole surface) 24 hours after instillation.
Iridial response was not evaluable.
Conjunctival redness was observed at 60 minutes (grade 3) and 24 hours (grade 2) after instillation.
Chemosis was observed at 60 minutes (grade 3) and 24 hours (grade 4) after instillation.
As lesions such as a grade 4 corneal opacity are generally not reversible, the study was stopped 24 hours after instillation and the animal was humanely killed.
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