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Diss Factsheets
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EC number: 288-422-3 | CAS number: 85721-12-6
- 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:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Colipa report n. C174
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Neutral Red Uptake assay (NRU) on human keratinocytes
- Deviations:
- not specified
- Principles of method if other than guideline:
- The NRU cytotoxicity assay procedure is a cell survival/viability chemosensitivity assay based on the ability of viable cells to incorporate and bind neutral red (NR), a supravital dye. NR is a weak cationic dye that readily penetrates cell membranes by non-ionic diffusion and accumulates intracellularly in lysosomes. Alterations of the cell surface or the sensitive lysosomal membrane lead to lysosomal fragility and other changes that gradually become irreversible. Such changes brought about by the action of xenobiotics result in a decreased uptake and binding of NR. It is thus possible to distinguish between viable, damaged, or dead cells, which is the basis of this assay.
In several studies for its ability to predict eye irritation potential as reflected by Draize scores. (Guidance Document on Using In VitroData to Estimate In Vivo Starting Doses for Acute Toxicity - ICCVAM) - GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- Human keratinocytes (HaCat).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 3.162 to 10000 µg/ml medium
- Duration of treatment / exposure:
- 24 hours
- Details on study design:
- Monolayers of human keratinocytes (HaCat) were exposed in 96-well microtiter plates to various concentrations of Curry Red for 24 hours and cell viability was measured by neutral red uptake.
The concentration causing a 50 % reduction in neutral red uptake compared to the concurrent control (NRU-50) is determined. This figure, as a measure for
cytotoxicity of a test item in this cell culture, is compared to findings with known eye irritants under identical test conditions and allows a prediction of the eye irritation potential of a test item.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- No NRU-50 value could be determined as the viability was still 71 % in the first and 69 % in the second assay after treatment with the highest test concentration of 10000 μg/ml medium.
Thus, the NRU-50 was > 10000 μg/ml.
The NRU-50 values obtained with the positive control SLS (12.5 and 15.6 μg/ml) were in the range of the historical control data of the laboratory and demonstrate the validity and sensitivity of the assay.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not eye irritant
- Executive summary:
According to the classification system of the performing laboratory discriminating between non irritant, not-classified and severe, the tested substance is classified as non-irritant.
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