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EC number: 280-744-2 | CAS number: 83763-57-9
- 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
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study is equivalent to following methods:
- according KAROL et al. 1995; KAROL et al. 1978; DeCEAURRIZ et al. 1987; BARROW et al, '1977, BOTHAM et al., 1988; BOTHAM et al., 1989
- exposition technical criteria according OECD 403 and corresponding EG-guideline as relevant so far for this study type
- Measuring according to general recommendations of ASTM E 981-84; ALARIE, 1973 - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[[6-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]naphthalene-1,5-disulphonic acid, sodium salt
- EC Number:
- 280-744-2
- EC Name:
- 2-[[6-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]naphthalene-1,5-disulphonic acid, sodium salt
- Cas Number:
- 83763-57-9
- Molecular formula:
- C24H11ClF2N5Na3O10S3 C24H14ClF2N5O10S3.xNa C24H13ClF2N5NaO10S3 [724.014 gr/mol]
- IUPAC Name:
- sodium 6-(2-{6-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazen-1-yl)-5-sulfonaphthalene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Orange 64
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbtight-White
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 1-2 months
- Weight at study initiation: 235 to 250 g
- Housing: Makrolon-cages type IV (4 animals per cage); cages were cleaned once a week and disinfected with Zephirol (10%), Litter: wooden granular (Typ S 8/15; Ssniff - Spezialdiaten GmbH, D 4770 Soest)
- Diet (e.g. ad libitum): ad libitum; fixed formula standard diet “Altromin 3022 – Haltungsdiät für Meerschweinchen from Altromin GmbH, Lage)
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 1 week
- Indication of any skin lesions: only health and symptom free animals were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
In-life dates:
Induktionsphase: 13.05.91-- 17.05.91
Challengephase: 05.0691 - 06.06.91
Sektion: 07.06.91
Test system
- Route of induction exposure:
- intradermal
- Route of challenge exposure:
- inhalation
- Vehicle:
- physiological saline
- Concentration:
- intradermal induction: 15%
- No. of animals per dose:
- 8
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 times intradermal application, 2 applications of 100 µL each
- Test groups: 2 applications of 100 µL of 5% test item in peanut oil, each
- Control group: 2 applications of 100 µL of peanut oil, each
- Site: on the flank, Day 0: cranial, Day 2: thoracal, Day 4: caudal
- Frequency of applications: every second day
- Duration: 4 days
- Concentrations: 15% in physiological salin
B. CHALLENGE EXPOSURE
- No. of exposures: 2 à 30 min
- Day(s) of challenge: 2
- Exposure period: day 21 to 24
- Test groups: day 24: 4 mg/m³
- Control group: day 23: 5 or 8 mg/m³
- Site: head-nose exposition
- Concentrations: ca 4 mg/m³ air
- Evaluation (hr after challenge): respiratory rate, respiratory volume, respiratory minute volume, inspiration and expiration time was evaluated during and 20 h after challenge exposure; animals were killed 1 day after the last challenge exposure - Positive control substance(s):
- not specified
- Negative control substance(s):
- other: vehicle
Results and discussion
- Results:
- Induction:
No test item-related effects other than stainingof the skin
Challenge:
No effects other than lachrymation in some animals
Lung function tests:
Single animals showed changes in respiration. There were no delayed pulmonary reactions. See also table 2 in "Any other information on results incl. tables".
Body weight:
There were no changes in body weights observed.
Gross pathology:
in some animals the lung was bloated
Lung weights:
Lungs of treated animal showed higher weights - Positive control results:
- NA
- Negative control results:
- No effects were observed in vehicle control animals.
Any other information on results incl. tables
Number of Animals with positive Reaction during Challenge Phase
Induction | Anaphylaxie | Immediate | Delayed |
Vehicle | 0/8 | (3)/8 | 1/8 |
Test item | 0/8 | 5/8 | 0/8 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No clear test-substance related effects were noted, as some respiratory/sensitising effects were also seen in the vehicle group.
- Executive summary:
In a respiratory sensitization study with the test item, young adult Pirbright-White-Dunkin-Hartley guinea pigs were tested for respiratory sensitisation. The test was carried out according to published methods of KAROL et al. 1985 and 1978; DeCEAURRIZ et al. 1987; BARROW et al, 1977, BOTHAM et al., 1988 and BOTHAM et al., 1989.
No effects in body weights were observed compared to the vehicle control. Slightly higher lung weights were seen in test item treated animals. Gross pathological findings in the lung consisted of bloated lungs in some test item treated animals..
During and after the challenge phase, 3/8 control and 5/8 test animals showed reactions of the immediate-type. In addition, one control animal showed delayed effects.
Number of Animals with positive Reaction during Challenge Phase
Induction Anaphylaxie Immediate Delayed Vehicle 0/8 (3)/8 1/8 Test item 0/8 5/8 0/8 Due to the positive effects in vehicle control animals, no clear conclusion on respiratory sensitisation effects can be drawn
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