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EC number: 274-418-9 | CAS number: 70210-21-8
- 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
- Study period:
- 13.10.-13.11.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Based on preliminary information about the substance irritancy potential the test Skin Sensitisation in Guinea Pigs was performed.
Test material
- Reference substance name:
- Trisodium 7-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 274-418-9
- EC Name:
- Trisodium 7-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 70210-21-8
- Molecular formula:
- C26H20ClN7O10S3.3Na
- IUPAC Name:
- trisodium 7-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Orange 5- Physical state: solid, powder- Analytical purity: 90% (w/w)- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 10% (w/w)- Composition of test material, percentage of components:- Lot/batch No.: 8001- Expiration date of the lot/batch: unlisted- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: BFA
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Luboš Sobota, 298 03 Městec Králové, monitored breeding farm, RČH CZ 21760039- Age at receiving: 6-7 weeks - Weight at study initiation:- Housing: Sterilized shavings of soft wood, Monitored conditions, microbiologically defined background, according to internal SOP No.40- Diet: Pelleted standard diet for guinea pigs ad libitum – Altromin 3023 for Giunea pig - Water: Drinking tap water ad libitum (supplemented by ascorbic acid)- Acclimation period: 5 days-Number: 32 animals: -Sex: 12 males + 20 femalesENVIRONMENTAL CONDITIONSMicroclimatic conditions: Room temperature 22 ± 3°C, permanently monitoredRelative humidity 30 – 70 %, permanently monitoredLight: 12 hour light/dark cycle: 6am-6pm/6pm-6am
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Natrii chloridum 0.9%, FCA, Vaseline album
- Concentration / amount:
- 0,1 ml
- Day(s)/duration:
- 0-6
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 20% test substance in vaseline
- Day(s)/duration:
- 20
- No. of animals per dose:
- 32 animals:Pilot experiment: 2 animalsExposed group: 20 animalsControl group: 10 animals
- Details on study design:
- MAIN STUDYA. INDUCTION EXPOSUREInduction: Intradermal InjectionsDay 0 – treated groupThree pairs of intradermal injections of 0.1 mL volume were given in the shoulder region, which was cleared of hair so that one of each pair lies on each side of the midline.Injection 1: a 1:1 mixture (v/v) Freunds Complete Adjuvant (FCA)/ physiological salineInjection 2: the test substance 30% in physiological salineInjection 3: the test substance 30% in a 1:1 mixture (v/v) FCA/ physiological salineDay 0 – control groupThree pairs of intradermal injections of 0.1 mL volume were given in the same sites as in the treated animals.Injection 1: a 1:1 mixture (v/v) Freunds Complete Adjuvant (FCA)/ physiological saline Injection 2: physiological salineInjection 3: physiological saline in a 1:1 mixture (v/v) FCA/ physiological salineInduction: Topical Application Day 6 - treated group24 hours before application (day 5) the test area was cleared of hair. A filter paper (2 x 4 cm) with 30% test substance in vaseline was applied to the test area and held in contact by an occlusive dressing for 48 hours. Day 6 – control group24 hours before application (day 5) the test area was cleared of hair. A filter paper (2 x 4 cm) with vaseline only was applied in a similar manner to the test area and held in contact by an occlusive dressing for 48 hours.B. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: Day 20- Exposure period: 24h- Test groups: test substance in vaseline, vaseline- Control group: test substance in vaseline, vaseline- Site: R flank/L flank- Concentrations: 20% substance in vaseline- Evaluation (hr after challenge): 48h and 72hOBSERVATIONS:Clinical signs of intoxication and health condition: dailyMortality/viability: dailyBody weight: 0 and 24th dayThe skin reaction: 24, 48, 72, 96 and 120 hours after intradermal injection48, 72, 96, 120 hours after induction – topical application48 and 72 hours after challenge
- Positive control substance(s):
- yes
- Remarks:
- α-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Reliability of the experimental technique is checked periodically in about six-month interval by the experiment with known sensitiser α-hexylcinnamaldehyde. The result of last experiment (September 2015): positive skin reaction – 5 animals (total number of animals in exposed group = 10), i.e. 50%. According to the guideline the minimal number of animals with positive skin reaction should be 30%. The result is satisfactory.The results of reference study are described in Study No. 123/12/6MK- Ref/09/2015: Alfa-hexylcinnamaldehyd - Senzibilizace kůže, VUOS-CETA Report No. 15-511, 2015.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 20% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The exposed animals showed no pathological skin reactions and no other negative clinical symptoms throughout the experiment.The body weight of animals increased through the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.The test substance, Reactive Orange 5, was not shown to be a contact allergen in guinea pigs.
- Executive summary:
The test substance, Reactive Orange 5, was tested for the assessment of skin allergic effects using albino guinea pigs (strain BFA).
The test was performed according to the EU Method B.6, Skin sensitisation.
The method is analogous to the OECD Test Guideline No. 406, Skin sensitisation.
The Magnusson and Kligman maximization procedure was followed. The pilot experiment was implemented on 2 animals.
The main test was performed on 20 treated and 10 control animals.
The experiment proceeded in three phases: two induction phases - topical application and the challenge phase. Potential skin reactions were evaluated at the end of experiment.
The evaluation of skin reactions in the exposed group carried out at 48 and 72 hours after the start of the challenge phase of study did not show any changes in skin of animals in both flanks.
No allergic skin reactions were observed incontrol group 48 hours and at 72 hoursfrom the start of application of the challenge dose.
No other negative clinical symptoms through the experiment were recorded.
The test substance, Reactive Orange 5,was not shown to be a contact allergen in guinea pigs.
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