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Diss Factsheets
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EC number: 942-492-8 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 April 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- 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)
- Version / remarks:
- Update 26/06/2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
- Molecular formula:
- Substance is a UVCB and cannot be defined by molecular and structural information
- IUPAC Name:
- Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch 02 November 2020
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a
by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee
after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with
antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported
to the test facility over ice packs on the same day of slaughter. The corneas were refrigerated
on arrival and used within 24 hours of receipt.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.75 ml neat substance
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- Three corneas were randomly allocated to the negative control. Three corneas were also
allocated to the test item and three corneas to the positive control item. - Details on study design:
- NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Sodium chloride 0.9% w/v
SOLVENT CONTROL USED (if applicable): no
POSITIVE CONTROL USED: Neat Ethanol
APPLICATION DOSE AND EXPOSURE TIME: 0.75 ml / 10 min
TREATMENT METHOD: [closed chamber / open chamber]
POST-INCUBATION PERIOD: yes. If YES please specify duration: 120 min
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: rinsed 3 times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red.
- POST-EXPOSURE INCUBATION: The holders were incubated, anterior chamber facing forward, at 32 ± 1 ºC for 120 minutes.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group
- Corneal permeability: 360 μL of media representing each cornea was dispensed into the appropriate wells of a pre-labeled 96-well plate. The optical density was measured (quantitative viability analysis) at 492 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS): mean opacity value + (15 x mean permeability OD492 value)
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
- Value:
- 3.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Value 0.3
- Positive controls validity:
- valid
- Remarks:
- Value 38.2
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: The corneas treated with the test item were clear post treatment and post incubation.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control values were within accepted limits.
- Acceptance criteria met for positive control: The positive control In Vitro Irritancy Score was within the acceptance range.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- According to UN GHS Classification for the test item Thermal cracking oil from blends of
rubber, fuel oils and paraffin waxes, steam distillation condensate, No stand-alone prediction
of eye irritation can be made under the conditions of the test. - Executive summary:
An in vitro Bovine Corneal Opacity and Permeability (BCOP) assay was performed in line with OECD Testing Guideline 437 (Bovine Corneal Opacity and Permeability Test Method). The study was GLPcompliant.
The undiluted test material was applied to three cattle corneas obtained from an abattoir at a volume of 0.75 mL, after which each cornea was incubated at 32±1°C for 10 minutes.Opacity and permeability of corneas were measured following exposition.
Negative and positive controls were performed and considered as valid.An In Vitro Irritation Score (IVIS) of 3.8 was calculated for the test item from corneal opacity and permeability measurements. According to UN GHS Classification for the test item Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate, No stand-alone prediction of eye irritation can be made under the conditions of the test.
Since the OECD 437 is designed to identify Eye damage 1 or not classified substances, a decision to classify the substance as eye irritant cat. 2 was taken.
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