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EC number: 955-780-3 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Remarks:
- read across data
- 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 assessement report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Environment and Quality of Life - Reports (Seventh Series) for test chemical
- Author:
- European Commission (EC) - Scientific Committee on Cosmetology (SCC)
- Year:
- 1 988
- Bibliographic source:
- Environment and Quality of Life - Reports (Seventh Series) for test chemical European Commission (EC) - Scientific Committee on Cosmetology (SCC) 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea pig maximisation test
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of test chemical on guinea pig skin.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
- EC Number:
- 218-326-9
- EC Name:
- Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
- Cas Number:
- 2118-39-0
- Molecular formula:
- C26H15N5Na4O12S4
- IUPAC Name:
- Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
- Test material form:
- solid
- Details on test material:
- - Name of test material : Food Black 2
- Molecular formula : C26H19N5O13S4.4Na
- Molecular weight : 809.651 g/mol
- Substance type: organic
- Physical state: solid
InChI: 1S/C26H19N5O12S4.4Na/c27-20-12-18-13(9-23(20)46(38,39)40)10-24(47(41,42)43)25(26(18)32)31-30-22-8-7-21(17-6-3-15(44(33)34)11-19(17)22)29-28-14-1-4-16(5-2-14)45(35,36)37;;;;/h1-12,32H,27H2,(H,33,34)(H,35,36,37)(H,38,39,40)(H,41,42,43);;;;/q;4*+1/p-4/b29-28+,31-30+;;;;
Smiles:c1(S(=O)(=O)[O-])c(\N=N\c2c3c(ccc(S(=O)[O-])c3)c(\N=N\c3ccc(S(=O)(=O)[O-])cc3)cc2)c(O)c2c(c1)cc(S(=O)(=O)[O-])-])c(N)c2.[Na+].[Na+].[Na+].[Na+]
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : Food Black 2
- Molecular formula : C26H19N5O13S4.4Na
- Molecular weight : 809.651 g/mol
- Substance type: organic
- Physical state: solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 ml of 0.05-0.1%
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: Not specified
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Not specified
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 doses
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Frequency of applications: 10 doses in 21 days
- Duration: 21 days
- Concentrations: 1 ml 0.05-0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: Not specified
- Day(s) of challenge: 1
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Concentrations: Not specified
- Evaluation (hr after challenge ): Not specified
OTHER: Challenge was provided 14 days after induction - Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1 ml 0.05-0.1%
- No. with + reactions:
- 0
- Clinical observations:
- No skin allergic reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Test chemical when injected to guinea pig skin in the concentration 0.05-0.1% 10 doses in isotonic saline and challenged after 14 days produced no skin allergic reaction .Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
- Executive summary:
The read across substance Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (CAS no.2118 -39 -0, E.C. no.: 218 -326 -9) was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05 -0.1% in isotonic saline , 10 doses for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.
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