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Diss Factsheets
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EC number: 619-856-7 | CAS number: 1056196-56-5
- 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:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- HET-CAM Test. No guideline available. However, the method is based on scientifically accepted publications; moreover, the study was conducted according to internal SOPs and was documented well
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- There are no official national or international guidelines for the HET-CAM Test; however, the study is performed according to the methods described in publications cited in the study protocol.
- Principles of method if other than guideline:
- - Principle of test: With the HET-CAM Test the potential of severe eye/mucous membrane damage using the chorionallantoic membrane (CAM) of fertilized, incubated hen eggs is tested. In the test, incubated hen’s eggs are opened carefully on day 9 and the CAM is exposed. Solid test substances are applied, if possible, on approximately the half of the membrane area, starting from the center. The visible parts of the membrane are observed. The time until appearance of unambiguous reactions is recorded. The reaction outcomes are coagulation and other reactions like e.g. haemorrhage or vessel lysis. lf reactions cannot be identified due to the nature of the test substance, the test substance will be removed by washing with 0.9% aqueous NaCl-solution after 3.5 minutes or. A final assessment of the CAM is performed immediately after washing.
- Parameters analysed / observed:Coagulation, Haemorrhagia - GLP compliance:
- no
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 33470-153 FK
- Expiration date of the lot/batch: The sponsor guarantees the storage stability at least until 30 Apr 2009.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL:
- Stability under test conditions: Stability is guaranteed by the sponsor.
- Solubility and stability of the test substance in the solvent/vehicle: Since the test substance was determined to be not soluble in doubly distilled water or in olive oil at the concentration of 10%, a study protocol based on the undiluted solid test substance was followed. Because the test substance was applied undiluted, no analysis of the test substance in a vehicle was required.
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: White Leghorn, SPAFAS lnc., USA, SPF Premium
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability: The HET-CAM Test is an alternative in vitro method for testing of severe eye irritation to the eye of the rabbit. With the HET-CAM Test the potential of severe eye/mucous membrane damage using the chorionallantoic membrane (CAM) of fertilized, incubated hen eggs is tested. The test method does not yet allow for the evaluation of eye irritation. The result does not exclude an eye irritation potential of the test substance.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: Fresh, fertilized hen eggs produced under controlled SPF conditions were used. Hen eggs are recommended as preferred type of eggs in the references describing the method. Analogous to test animals, controlled SPF housing guarantees a defined microbiological status of the eggs. Contaminations also cause adverse effects or lack of comparability on the results of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Duration of treatment / exposure:
- 210 seconds
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):Yes, 0.9% NaCl solution
- Time after start of exposure: 3.5 min
SCORING SYSTEM: 0 no visible chnage; 1 slight reaction; 2 moderate reaction; 3 severe reaction
TOOL USED TO ASSESS SCORE: stereomicroscope
Results and discussion
In vitro
Results
- Irritation parameter:
- morphological effects
- Run / experiment:
- run 1; 3 eggs evaluated
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not specified
- Remarks on result:
- other: no risk of serious eye damage
- Remarks:
- no reaction
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: CAMs with signs of pre-existing damage were excluded from the assay.
Any other information on results incl. tables
Table 1: Summarized Results
Concentration: |
Egg-No.: | Observation period (seconds): |
Grading of effects observed after test substance removal by washing: |
Additional findings | ||
Haemorrhagia: | Coagulation: | Haemorrhagia: | Coagulation: | |||
Undiluted |
1 | 210 | 210 | 0 | 0 | none |
2 | 210 | 210 | 0 | 0 | none | |
3 | 210 | 210 | 0 | 0 | none | |
Mean: |
n = 3 | 210 | 210 | 0 | 0 |
Grading: 0 = no reaction; 1 = slight; 2 = moderate; 3 = severe
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No risk of serious damage to the eyes. However, the test method does not yet allow for the evaluation of eye irritation. The result does not exclude an eye irritation potential of the test substance.
- Executive summary:
The potential of severe eye/mucous membrane damage was tested using the HET-CAM Test.
Therefore, the chorionallantoic membrane (CAM) of fertilized, incubated hen eggs was exposed with the undiluted test substance.
No haemorrhagia or coagulation was identified during an observation period of 210 seconds.
Therefore, the test substance is considered to cause no risk of serious damage to the eyes.
However, the test method does not yet allow for the evaluation of eye irritation. The result does not exclude an eye irritation potential of the test substance.
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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