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Diss Factsheets
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EC number: 294-510-2 | CAS number: 91723-07-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hibiscus esculentus, Malvaceae.
- 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:
- June 27, 2017 to February 28, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Okra, ext.
- EC Number:
- 294-510-2
- EC Name:
- Okra, ext.
- Cas Number:
- 91723-07-8
- Molecular formula:
- not applicable
- IUPAC Name:
- Hibiscus abelmoschus, ext.
Constituent 1
- Specific details on test material used for the study:
- 407/DELIP HIBISCUS SEED;
batch: 0016468911;
Date of manufacture: 09 Dec 2016,
Expiry date: 09 Dec 2019.
state:beige solid
Test animals / tissue source
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- not applicable
The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.
To assess the ability of the test material to directly reduce MTT a pretest was performed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes (tissue incubations for positive and negative controls included)
- Amount / concentration applied:
- 0.05 mL
- Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- 18h
- Number of animals or in vitro replicates:
- Two tissue samples were used per group.
- Details on study design:
- Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The
quotient of the values indicates the relative tissue viability.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Viability (%)
- Run / experiment:
- test run 1
- Value:
- 36.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Viability (%)
- Run / experiment:
- test run 2
- Value:
- 20.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Viability (%)
- Run / experiment:
- test run 3
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- 1st test run:
The final relative mean viability of the tissues treated with the test substance after the 1st test
run was 36.6%. However, the acceptance criteria for the killed controls were not met: High
values for direct MTT reduction (OD values > 0.35 and mean value of the killed control tissues
30.7% with individual values 30.7% and 30.6%) and high variability of the test-substance
treated tissues (difference between the tissues 18.8% with inidividual values 57.9 and 76.6%
close to the classification cut-off) a 2nd test run was performed to verify the result.
2nd test run:
The final relative mean viability of the tissues treated with the test substance after the 2nd test
run was 20.6%. However, the acceptance criteria for the killed controls were not met, becaue
exceptionally high values for direct MTT reduction and high variability between the single killed
control tissues (OD values > 0.35 and mean value of the killed control tissues 30.7% with
individual values 84.3% and 50.4%) were observed. Thus, a 3rd test run was performed.
3rd test run:
The final relative mean viability of the tissues treated with the test substance after the 3rd test
run was 0.0%. However, the acceptance criteria for the killed controls were not met, because
exceptionally high values for direct MTT reduction and high variability between the single killed
control tissues (OD values > 0.35 and mean value of the killed control tissues 115.3% with
single values 153.0% and 77.6%) were observed. In addition high variability of the testsubstance
treated tissues (difference between the tissues 22%) was noted. Further, the final
relative mean viability of the tissues treated with the test substance after the 3rd test run was
set to zero after substracting the mean viabilaity of the killed controls form the man viability of
the test-substance treated tissues.
Any other information on results incl. tables
The positive control methyl acetate decreased the mean viability to 24% of control cultures.
The negative control water did not affect the viability of the control cultures
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
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