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EC number: 235-440-4 | CAS number: 12227-78-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- OPINION ON CI 45430 (Erythrosine) _ Skin sensitization
- Author:
- Scientific Committee on Consumer Safety SCCS OPINION
- Year:
- 2 010
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS; 22 June 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Test was performed by using OECD Guideline 406 (Skin Sensitisation).
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Reference substance name:
- Erythrosine
- IUPAC Name:
- Erythrosine
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): Erythrosine (16423-68-0)
- Molecular formula (if other than submission substance): C20-H6-I4-O5.2Na
C20-H8-I4-O5.2Na
- Molecular weight (if other than submission substance): 879.8424 g/mol
- Substance type: Organic
- Physical state: Solid(powder)
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Sodium chloride and Freund’s adjuvans
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- other: 1st challenge : Intradermal 2nd challenge : Epidermal, occlusive
- Vehicle:
- other: Sodium chloride and Freund’s adjuvans
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 19 animals
- Details on study design:
- Details on study design
RANGE FINDING TESTS: No data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: Upto 10 intradermal injections
- Test groups: 19 animals
- Control group: No data available
- Site: intradermal injection
- Frequency of applications: 10 intradermal injections
- Duration: No data available
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1st challenge after
14 days (intradermally), 2nd challenge after additional 10 days (epidermally, occlusive)
- Exposure period: No data available
- Test groups: 19 animals
- Control group: No data available
- Site: No data available
- Concentrations: 0.1%
- Evaluation (hr after challenge): No data available - Positive control substance(s):
- yes
- Remarks:
- Tartrazin
Results and discussion
- Positive control results:
- Tartrazin
Sodium chloride was used as negative control
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 11
- Total no. in group:
- 19
- Clinical observations:
- Epidermal challenge did not cause an effect on skin
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 0.1%. No with. + reactions: 11.0. Total no. in groups: 19.0. Clinical observations: Epidermal challenge did not cause an effect on skin.
Any other information on results incl. tables
Positive reactions could be observed in 11 of 19 erythrosine-treated animals. After the epidermal challenge, none of the 19 animals exhibited signs of positive reactions. Therefore, a further intradermal challenge was performed later on after which 15 of 19 animals reacted positive
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Erythrosine (16423-68-0) does not exhibit the skin sensitization potential as has been observed from the study on guinea pigs for a period of 3 weeks
- Executive summary:
Skin sensitization test was performed on Guinea pig with 0.1% solution of erythrosine for 3 weeks.
Animals received 10 intradermal injections of a 0.1% solution of the colour. The last six injections were given using Freund’s adjuvans. After 14 days, a further intradermal injection was given as challenge. A second epidermal, occlusive challenge was given after additional 10 days. After a further intradermal challenge, positive reactions could be observed in 11 of 19 erythrosine-treated animals. After the epidermal challenge, none of the 19 animals exhibited signs of positive reactions. Therefore, a further intradermal challenge was performed later on after which 15 of 19 animals reacted positive.
Epidermal challenge did not cause any effect on skin; hence, erythrosine is not regarded as a skin sensitizer.
According to the CLP regulation, the substance does not classify as a skin sensitizer.
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