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EC number: 249-352-9 | CAS number: 28983-56-4
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 18- COLIPA n° C175
- Author:
- THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP)
- Year:
- 2 004
- Bibliographic source:
- THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP), last updated 23 April 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Neutral Red Uptake assay (NRU) on human keratinocytes with the modification that human keratinocytes of the HaCaT cell line were used.
- Principles of method if other than guideline:
- The ocular irritation potential of Acid Red 18 was assessed by determining the Cytotoxicity in the neutral red uptake assay (NRU) on human keratinocytes with the modification that human keratinocytes of the HaCaT cell line were used.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate
- EC Number:
- 220-036-2
- EC Name:
- Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate
- Cas Number:
- 2611-82-7
- Molecular formula:
- C20H14N2O10S3.3Na
- IUPAC Name:
- 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-((4-sulfo-1-naphthalenyl)azo)-, trisodium salt
- Test material form:
- solid
- Details on test material:
- Name of the test chemical : 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-((4-sulfo-1-naphthalenyl)azo)-, trisodium salt
Common Name: Acid Red 18
Molecular Formula: C20H11N2Na3O10S3
Molecular Weight: 604.5 g/mol
Substance Type: Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical : 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-((4-sulfo-1-naphthalenyl)azo)-, trisodium salt
Common Name: Acid Red 18
Molecular Formula: C20H11N2Na3O10S3
Molecular Weight: 604.5 g/mol
Substance Type: Organic
Physical State: Solid
Batch number : lot A003401
Test animals / tissue source
- Species:
- other: HaCaT human keratinocytes
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test Tissue
- Type: HaCaT human keratinocytes
Test system
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 681 – 10000 μg/ml [1% in water]
- Duration of treatment / exposure:
- no data available
- Observation period (in vivo):
- no data available
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- Two independent NRU assays with identical doses were performed
- Details on study design:
- no data available
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: cytotoxicity
- Run / experiment:
- NRU 50
- Value:
- > 10 000
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: cell viability
- Run / experiment:
- NRU 50
- Value:
- 61
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: NRU-50 value determined from the cytotoxicity curves was 61% in the first assay
- Irritation parameter:
- other: cell viability
- Run / experiment:
- NRU 50
- Value:
- 70
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: NRU 50 was determined to be 70% in the second assay
- Other effects / acceptance of results:
- No NRU-50 value could be determined from the cytotoxicity curves as the viability was still 61% in the first assay and 70% in the second, so the NRU-50 was reported to be > 10000 μg/ml
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No NRU(Neutral Red uptake)-50 value could be determined from the cytotoxicity curves as the viability was still 61% in the first assay and 70% in the second, so the NRU-50 was reported to be > 10000 μg/ml.
Hence, Acid red 18 can be considered not irritating to Human Keratinocytes in the neutral red uptake assay. - Executive summary:
The ocular irritation potential of Acid Red 18 was assessed by determining the Cytotoxicity in the neutral red uptake assay (NRU) on human keratinocytes with the modification that human keratinocytes of the HaCaT cell line were used.The treatment was performed in serum-free culture medium. Doses from 681 – 10000 μg/ml [1% in water] were applied together with appropriate controls.Two independent NRU assays with identical doses were performed.No NRU-50 value could be determined from the cytotoxicity curves as the viability was still 61% in the first assay and 70% in the second, so the NRU-50 was reported to be > 10000 μg/ml.
Hence, Acid red 18 can be considered not irritating to Human Keratinocytes in the neutral red uptake assay.
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