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Diss Factsheets
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EC number: 274-700-1 | CAS number: 70616-89-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17.7.1992
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Information not available.
Test material
- Reference substance name:
- Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
- EC Number:
- 233-311-7
- EC Name:
- Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
- Cas Number:
- 10114-47-3
- Molecular formula:
- C28H20N4O6S4.2Na
- IUPAC Name:
- disodium 2,2'-(diazene-1,2-diyldi-4,1-phenylene)bis(6-methyl-1,3-benzothiazole-7-sulfonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: orange powder- Batch No.: 31/94- Prevailing particle size: 2 - 4 µm
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Anlab, Prag, Czech Republic- Females (if applicable) nulliparous and non-pregnant: yes- Microbiological status of animals, when known: without parasites, microorganisms, viruses and fungi- Weight at study initiation: 300 - 366 g- Housing: T4 cages (5 animals per cage)- Diet (e.g. ad libitum): granulated commercially produced feed mixture- Water (e.g. ad libitum): drinking water with addition of ascorbic acid (20 mg/animal/day)- Acclimation period: 1 week
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 0
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 0
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 % w/w Reactive Orange 13
- Day(s)/duration:
- day 7
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 20
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % w/w Reactive Orange 13
- Day(s)/duration:
- day 27
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Treated group: 20 animalsControl group: 10 animals
- Details on study design:
- MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 2 (intradermal and epicutaneous) - Test groups: 1 (20 animals) - Control group: 1 (10 animals) - Site: nape - Concentrations: 1 % (intradermal exp.), 25 % (epicutaneous exp.) B. CHALLENGE EXPOSURE - No. of exposures: 2 - Day(s) of challenge: day 20 and 27 - Test groups: 1 (20 animals) - Control group: 1 (10 animals) - Site: nape - Concentrations: 1 % - Evaluation (hr after challenge): 1, 24, 48 and 72 hours after application
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1 % w/w Reactive Orange 13
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin or any clinical reaction
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to results of Guinea Pig Maximisation Test, the test substance, Reactive Orange 13, need not be classified as skin sensitiser, pursuant to Regulation (EC) No. 1272/2008.
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