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Diss Factsheets
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EC number: 946-767-3 | 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
- Remarks:
- Alternative method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix VI of the French National Register N°302 of December, 1999
- Deviations:
- no
- Principles of method if other than guideline:
- This test is an alternative method which aims to assess a test item eye irritant potential. The principle is based on the test item cytotoxicity assessment by determination of the concentration which leads to 50% of cells death (IC50) on a cell monolayer, using the Neutral Red Uptake Method.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Saccharides of mannose and galactose from Ceratonia Siliqua seed
- IUPAC Name:
- Saccharides of mannose and galactose from Ceratonia Siliqua seed
- Test material form:
- liquid
- Details on test material:
- Clear yellow
Constituent 1
Test animals / tissue source
- Species:
- other: Rabbit cornea fibroblasts
- Strain:
- other: SIRC line (Cat N°2-552 CCL60)
- Details on test animals or tissues and environmental conditions:
- Cells were cultured in the Test facility in DMEM medium supplemented with 10% of foetal calf serum, decomplementized at 56°C for 30 minutes, 1% of a penicillin/streptomycin solution and L-glutamine. Cells were kept and preserved in accordance with the internal procedures of the Test facility for freezing, unfreezing and subculturing.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Dilution at 5%, 15%, 25%, 35% and 50% of the test material are used
- Duration of treatment / exposure:
- contact with the test item = 60 secondes
- Observation period (in vivo):
- N/A
- Duration of post- treatment incubation (in vitro):
- not specified
- Number of animals or in vitro replicates:
- Each sample, negative and positive controls are tested on two cultures wells by assessed concentration.
5%, 15%, 25%, 35% in monoplicate and 50% in duplicate - Details on study design:
- Cells in culture were trypsined and counted in accordance with the internal procedure od the Test facility. Then cells are seeded in 24wells plate at the rate of 2 x 10^5 cells/well under a volume of 1 ml of complet DMEM medium and then incubated for 24 hours (37°C, 5% CO2).
A stock solution of 0.4% neutral red prepared in sterile conditions with distilled water and diluted at 1/80 in complete culture medium at 37°C.
A 1% solution of 100% acetic acid in 50° ethanol was prepared.
48h after seeding, the culture medium of each well was removed. 1ml of colouring solution of neutral red was deposited per well. The plates were incubated at 37°C,5% CO2 for 3hours.
After this time of contact, the colouring solution was removed and replaced by 1 ml of complete culture medium per well. The plates was maintained at room temperature for at least 30 mintutes before being put in contact with the test item.
Each well is firstly rinsed with 2 ml of PBS before being treated with 500 μL of each dilution of test item. The contact time is 60 seconds. Treatments are applied, preferably, well by well and the stopwatch is started when the treatment is applied.
After 55 seconds, the treatment solution is aspirated. At precisely 60 seconds, the well is rinsed 5 times (5x2 ml of PBS). The pipettes used forrinsing must held vertically. The supernatant is aspirated after each rinse. After the final rinse, the well remained without the medium while waiting the revealing phase.
After the culture plate has been fully treated, 1 ml of the revealing solution (acetic acid/ethanol : 1/100) is placed in each well. The plate is shaken approximatively 15 minutes.
The solutions revealed in each well were put in a 96-well microplate of 200 μL/well in duplicate.
Absorbances are measured at 540 nm against the blank (revealing solution) on an automatic microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Percentage of mortality observed at the 50% dilution (higher dilution tested)
- Value:
- ca. 22
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Estimated IC 50 (%)
- Value:
- > 50
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- The cytotoxicity of tested material was judged not very important
IC 50 is greater to 50% and the dealth cells rate at 50% of test item (higher dilution tested) has been assessed to 22%.
Applicant's summary and conclusion
- Interpretation of results:
- other: not very important cytotoxicity according to the adopted scale.
- Conclusions:
- Under the retained experimental conditions, the cytotoxicity of the test item may be classified as not
very important cytotoxicity according to the adopted scale. - Executive summary:
An in vitro eye irritation study was performed on rabbit cornea fibroblasts according to French national Method published in December 1999 in National register N° 302. The principle of the method is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
Positive and Negative controls were used. The IC50 was up to 50% and the death cells rate at 50% of test item (higher dilution tested) has been asessed to 22%.
Under the retained experimental conditions, the cytotoxicity of the tes item may be classified as not very important cytotoxicity according to the adopted scale.
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