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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
Endpoint summary
Administrative data
Description of key information
Skin sensitization:
1. No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye. Hence, the test chemical can be considered to not sensitizing to human skin.
2. 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.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- 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 - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 ml of 0.05-0.1%
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- not specified
- 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
- 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
- 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test
- Principles of method if other than guideline:
- Patch tests were performed on 312 consecutive patients to determine the allergic potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Department of Dermatology, University of Modena, Italy - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% and 10% in petrolatum
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% and 10%
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 312 consecutive patients
119 patients were tested with 5% concentration and remaining 193 with 10% concentration - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: single exposure
- Exposure period: 3 days
- Test groups: 312
- Control group: number not mentioned
- Site: healthy skin of the back
- Frequency of applications: daily for 3 days
- Duration: 3 days
- Concentrations: 5% - 119 patients; 10% - 193 patients
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 3 days
- Test groups: 312
- Control group: no data available
- Site: healthy skin of the back
- Concentrations: 5% - 119 patients; 10% - 193 patients
- Evaluation (hr after challenge): no data available
OTHER: 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients. - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 5 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 312
- Clinical observations:
- No positive allergic or irritant reactions were observed in the volunteers
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, the test chemical can be considered to not sensitizing to human skin. - Executive summary:
Patch tests were performed on 312 consecutive patients to determine the allergic potential of the read across substance 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 145017-98-7). 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential. The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients. No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye. Hence, the test chemical can be considered to not sensitizing to human skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization:
1. Patch tests were performed on 312 consecutive patients to determine the allergic potential of the read across substance 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 145017-98-7). 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential. The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients. No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye. Hence, the test chemical can be considered to not sensitizing to human skin.
2. 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.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above-summarized studies for target chemical and its structurally and functionally similar read across substances, it can be concluded that the test chemical does not cause skin sensitization thus considered a non-sensitizer. Comparing the above annotations with the criteria of CLP regulation, the test chemical does not classify as per CLP criteria.
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