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EC number: 281-889-4 | CAS number: 84057-71-6
- 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
Endpoint summary
Administrative data
Description of key information
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5 -sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6). The studies are as mentioned below:
Skin sensitization study was performed by peer reviewed journal for read across chemical in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for read across substance to detect its contact sensitivity.The patch of test chemical was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemical was considered to be not sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
The above result was further supported by another patch test conducted by peer reviewed journal for another read across chemical on healthy skin of 321 patients admitted to Allergological Services. The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum. The exposure duration was 3 days and the observations were made 3 hours after removal of the test material on day 4. The test material produced no skin allergic reaction. Hence, the test chemical was considered to be not skin sensitizing.
Based on the above summarized studies for target chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by performing patch tests on humans. - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 1. Not specified
2.- Source: 312 patients admitted to Allergological Services - Route:
- other: 1.epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 2 days
- Adequacy of induction:
- not specified
- Route:
- other: 2.epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% on 119 patients and 10% on 193 patients
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: 1.epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 2 days
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: 2.epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% on 119 patients and 10% on 193 patients
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1.28 healthy female volunteers
2.312 patients - Details on study design:
- 1.The test was performed with Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). The application was performed on the back for 2 days. Readings were made according to the ICDRG classification 24 h after the patches were removed.
2.The test material was installed in Finn chambers on Scanpor tape for the patch test
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: 3 days
- Test groups: 312 patients
- Control group: no data
- Site: back
- Frequency of applications: no data
- Duration: 3 days
- Concentrations: 5% on 119 patients and 10% 0n 193 patients
B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Exposure period: 3 days
- Test groups: 312 patients
- Control group: no data
- Site: back
- Concentrations: 5% on 119 patients and 10% on 193 patients
- Evaluation (hr after challenge): 3 hrs - Challenge controls:
- 1.Healthy female volunteers which were used as a control are of age 20 and 21.
2.No data available - Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- Skin sensitizing effects were not observed.NO
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 5% on 119 patients and 10% 0n 193 patients
- No. with + reactions:
- 0
- Total no. in group:
- 312
- Clinical observations:
- No positive allergic reactions were observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) was considered to be not sensitizing to the skin.
- Executive summary:
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5 -sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6). The studies are as mentioned below:
Skin sensitization study was performed by peer reviewed journal for read across chemical in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for read across substance to detect its contact sensitivity.The patch of test chemical was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemical was considered to be not sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
The above result was further supported by another patch test conducted by peer reviewed journal for another read across chemical on healthy skin of 321 patients admitted to Allergological Services. The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum. The exposure duration was 3 days and the observations were made 3 hours after removal of the test material on day 4. The test material produced no skin allergic reaction. Hence, the test chemical was considered to be not skin sensitizing.
Based on the above summarized studies for target chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5 -sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6). The studies are as mentioned below:
Skin sensitization study was performed by peer reviewed journal for read across chemical in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for read across substance to detect its contact sensitivity.The patch of test chemical was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemical was considered to be not sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
The above result was further supported by another patch test conducted by peer reviewed journal for another read across chemical on healthy skin of 321 patients admitted to Allergological Services. The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum. The exposure duration was 3 days and the observations were made 3 hours after removal of the test material on day 4. The test material produced no skin allergic reaction. Hence, the test chemical was considered to be not skin sensitizing.
Based on the above summarized studies for target chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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