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EC number: 916-632-3 | 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
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test performed prior to the implementation of the current acknowledged OECD testing and GLP guidelines.The study was conducted according to the method of Magnusson and Kligman.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method of Magnusson and Kligman
- Version / remarks:
- The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test, The Journal of Investigative Dermatology, Vol 52, Issue 3, pages 268 - 276, 1969
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1973
Test material
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 270-629-5
- EC Name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68460-07-1
- Molecular formula:
- C28H22N8O8S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 272-559-0
- EC Name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68877-33-8
- Molecular formula:
- C28H23N9O7S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Weight at study initiation: 230 - 385 g (mean 282 g)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 % in deionized water
0.1 mL injected respectively - Day(s)/duration:
- administered on days 1 to 7 of the study
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 % in deionized water
3 mL applied (patch) respectively on day 8 of the study - Day(s)/duration:
- patch was removed after 48 hours followed by a period of 22 days without treatment
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 % in deionized water
3 mL applied (patch) respectively on day 23 of the study - Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 30
- Details on study design:
- The GPMT is a highly sensitive method using Freund´s complete adjuvant as an immune enhancer. It includes both intradermal and topical induction treatment and closed challenge.
No details on study design remarked in the test report, but according to the method of Magnusson and Kligman, the following procedure is applied:
Three pairs of intradermal injections are given in the shoulder region which is cleared of hair: injection 1 is a 1:1 mixture of Freund's complete adjuvant and physiological saline, injection 2 is the test substance at the selected concentration in an appropriate vehicle and injection 3 is the test substance at the selected concentration formulated in a 1:1 mixture of Freund's complete adjuvant and physiological saline. On days 6-8, a filter paper loaded with test substance in a suitable vehicle is applied to the test area covered by occlusion for 48 hours.
Approximately one day before the application, if the substance is not a skin irritant, the test area is treated with 10 % sodium lauryl sulphate in vaseline, in order to create a local irritation. Control animals receive the same treatment using vehicle without test substance.
Challenge is carried out on days 20-22 in treated and control animals. A patch loaded with test substance is applied to one flank of the animals, a patch with the vehicle may also be applied
to the other flank. The patches are covered occlusively for 24 hours. The skin reaction is evaluated 24 and 48 hours after patch removal.
The following information was noted in the test report:
30 animals were used for the study, all treated with the test material
Induction phase: prior to application of the test substance the animals were weighed and shaved at the test sites.
Intradermal induction started on day 1 by injection of 0.1 mL of an aqueous 5 % solution of the test material respectively. After the last injection on day 7, animals were washed and again cleared of hair at the test sites. On day 8 a patch loaded with 3 mL of an 5 % aqueous solution of the test material was applied to the test area respectively and covered by occlusion for 48 hours. Then, the patch was removed.
After a rest period of 12 days without treatment, animals were washed and clipped free of hair. The challenge phase started on day 23 by application of a patch loaded with 3 mL of an 5 % aqueous solution of the test material and covered occlusively for 24 hours respectively.
The skin reaction was evaluated 24 and 48 hours after patch removal. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 mL of a 5 % aqueous solution
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- no signs of skin sensitization observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3 mL of a 5 % aqueous solution
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- no signs of skin sensitization observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
After dermal application the test areas were discolored by the test material.
One animal died on day 7, two animals during the rest period on days 12 and 16. Three further animals died during challenge period on days 25 and 26. Therefore only 24 animals were left for skin reaction evaluation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) no 1272/2008
- Conclusions:
- no indication of skin sensitization. Therfore, the test substance has not to be classified for skin sensitization according to Regulation (EC) no 1272/2008.
- Executive summary:
In a guinea pig maximisation test according to the method of Magnusson and Kligman, an aqueous 5 % solution of the test item was applied to 30 animals. In the intradermal induction phase 0.1 mL was injected respectively. For the dermal application, induction and challenge, a patch loaded with 3 mL of the 5 % solution was used. After removals of the patches the skin of the test sites was discolored by the test material in all animals, but skin reaction evaluation was still possible. Overall 6 animals died at different phases of the test period.
No signs of skin sensitization were observed in any animal at any reading after challenge phase. Thus, the test substance has not to be classified for skin sensitization according to Regulation (EC) no 1272/2008.
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