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Diss Factsheets
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EC number: 220-027-3 | CAS number: 2610-10-8
- 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:
- other: The test was performed on humans not following the official guidelines, some details on test conditions are missing. The study is acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human repeated insult patch test
- Deviations:
- not specified
- Principles of method if other than guideline:
- Valid human data
- GLP compliance:
- no
- Type of study:
- other: evaluation of dermal effects
- Justification for non-LLNA method:
- no data
Test material
- Reference substance name:
- Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
- EC Number:
- 220-027-3
- EC Name:
- Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
- Cas Number:
- 2610-10-8
- Molecular formula:
- C45H32N10O21S6.6Na
- IUPAC Name:
- hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulpho
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Two hundred individuals were employed to participate in this evaluation. Prior to inclusion in the study panel, all of-the candidates were briefed as to the purpo se of the study, the procedure to which they would be subjected, and the hazards which might be anticipated as a consequence thereof. Parents of minor participating in this study were briefed along with their children so that parentalconsent could be obtained.Informed-consent forms were obtained from all individuals, the parents signing on behalf of the participating minors. The ages of the participants selected ranged from 2 to 65 years. Approximately 1/3 were males and 2/3 were females.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- 4% of aqueous solutions
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- 4% of aqueous solutions
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: mean of readings
- Group:
- test chemical
- Dose level:
- 4% solution
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- human insult patch test
- Remarks on result:
- other: not determined
- Reading:
- other: mean of readings
- Group:
- negative control
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: mean of readings
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
In all of the applications, no visible skin changes signifying reaction to injury were observed in any of the 200 subjects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No participants showed an adverse effect about sensitizing. Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test subjects. In this case since 200 subjects were used, we may predict with 95% certainty that at least 98.34% of a general population will not be sensitized by this material.
- Executive summary:
All of the tested group, under the test conditions, were not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent or sensitizer in any of the 200 subjects.
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