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Diss Factsheets
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EC number: 249-008-8 | CAS number: 28407-37-6
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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 NTRL reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Contact Sensitization potential of Diazine Black H conc 125%
- Author:
- NTRL report
- Year:
- 1 983
- Bibliographic source:
- OTS0215154, NTRL report, last updated 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Draize- Shelanski Repeat Insult Patch Test
- Principles of method if other than guideline:
- Modified Draize- Shelanski Repeat Insult Patch Test was performed on human volunteers to ascertain the degree of sensitization caused by Chlorazol Black BH[CAS:2429-73-4].
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Trisodium 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate
- EC Number:
- 219-384-8
- EC Name:
- Trisodium 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate
- Cas Number:
- 2429-73-4
- Molecular formula:
- C32H24N6O11S3.3Na
- IUPAC Name:
- trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Common Name: Chlorazol Black BH
- Molecular formula : C32H21N6Na3O11S3
- Molecular weight : 830.717g/mole
- Substance type: organic
- Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Common Name: Chlorazol Black BH
- Molecular formula : C32H21N6Na3O11S3
- Molecular weight : 830.717g/mole
- Substance type: organic
- Physical State: Solid
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- no data available
- Day(s)/duration:
- ten alternate-day 24-hour period
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- no data available
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 208 male volunteers
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: ten alternate-day 24-hour period
- Exposure period: 24 hour period
- Test groups: 208
- Control group: number not mentioned
- Site: backs
- Frequency of applications: 10 alternate day applications
- Duration: 24 hours
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: one day
- Exposure period: 24 hours
- Test groups: 208
- Control group: no data available
- Site: backs
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 hours after removal of the challenge patches - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 208
- Clinical observations:
- No instances of contact sensitization were observed in any of the volunteers.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No instances of contact sensitization were observed in any of the volunteers.
Hence, Chlorazol Black BH[CAS:2429-73-4] can be considered to be not sensitizing to skin. - Executive summary:
Modified Draize- Shelanski Repeat Insult Patch Test was performed on human volunteers to ascertain the degree of sensitization caused by Chlorazol Black BH [CAS:2429-73-4].
Undiluted Chlorazol Black BH [CAS:2429-73-4] was applied to the patch sites on the backs of 208 male volunteersfor ten alternate-day 24-hour period under occlusion. Following a seven day rest period, challenge patches of Chlorazol Black BH [CAS:2429-73-4] were applied to the fresh sites on the backs of 208 male volunteers similar to the induction phase for 24 hours. The challenge sites were evaluated 24 hours after removal of the challenge patches.
No instances of contact sensitization were observed in any of the volunteers.
Hence,Chlorazol Black BH [CAS:2429-73-4] can be considered to be not sensitizing to skin.
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