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EC number: 286-839-5 | CAS number: 85391-83-9
- 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:
- 17 Sep - 12 Oct 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- EC Number:
- 286-839-5
- EC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Cas Number:
- 85391-83-9
- Molecular formula:
- C21H14ClF2N5O8S2.xNa
- IUPAC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red 123
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: deduced from weight: 1 - 2 month
- Weight at study initiation: 264 +/-10g
- Housing: Makrolon cage type IV, four animals per cage, caged changed at least once per week
- Diet (e.g. ad libitum): Altromon 3022, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: at least one week after delivery
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Route of induction exposure:
- intradermal
- Route of challenge exposure:
- inhalation
- Vehicle:
- water
- Remarks:
- for intradermal injection
- Concentration:
- induction: 3 repetitions of each two-times 100µl of a solution with 5% test substances in water
challenge: nominal 60mg test substance/m³ for 30 minutes - No. of animals per dose:
- 8 animals per dose and vehicle control
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: intradermal induction on day 0, 2 and 4
- Test groups: one test group
- Control group: one vehicle control
- Site: day 0: cranial; day 2: thoracal; day 4: caudal
- Concentrations: treatment at each exposure: test group: two-times 100µl of a solution with 5% test substance in water; vehicle control: two-times 100µl water
B. CHALLENGE EXPOSURE
- No. of exposures: 2:
- Day(s) of challenge: test group on day 22 and 24; control group on day 21 and 23
- Exposure period: inhalative exposure for ca. 30 minutes, nose/head only
- Test groups: induction exposure with test substance
- Control group: induction exposure with vehicle
- Concentrations: ca. 60mg test substance/m³ (aerosol)
- Evaluation (hrs. after challenge): 20h after challenge, section at test day 25
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation chamber
- Exposure chamber volume: ca. 20L
- Method of holding animals in test chamber: fixed in an exposure tube
- Source and rate of air: ca. 80% of added air is exhausted via an aersol filter to have a continues air flow.
- System of generating aerosols: a 0.7% (g/v) test substance water solution is fogged in a pre-chamber (nominal 500mL/m³, results in 3500mg test substance/m³), transfered to inhalation chamber by air flow
- Method of particle size determination: Aerodynamic Particle Sizer with Laser-Velocimeter
- Temperature, humidity, pressure in air chamber: temperature: ca. 22°C, humidity: > 90%
- Brief description of analytical method used: two times 25L air with a flow of 4L/min taken and analysed with gravimetric methods
- Samples taken from breathing zone: yes
- MMAD (Mass median aerodynamic diameter): 0.92µm
- Mass fraction < 3µm: 100%
- particles per cm³: 150315
OTHER:
- assessed endpoints: body weight, clinical signs, pulmunary function testing (breathing rate, breathing volume) for immediate and delayed reactions, section
Results and discussion
- Results:
- clinical signs: local skin reaction at 6 out of 8 animals during induction exposure in test substance group, no reactions in vehicle group; no reactions during challenge exposure
body weight: not affected
pulmonary function testing (breathing rate, breathing volume) for immediate and delayed reactions: 5 out of 8 animals showed immediate reactions in the test substance group, delayed reactions at 3 out of 8 animals in both groups
section: no lung irritation observed during section, lung weight not affected
Any other information on results incl. tables
treatment | anaphylactic shock | immediate reaction | delayed reaction |
vehicle control | 0/8 | 0/8 | 3/8 |
test substance | 0/8 | 5/8 | 3/8 |
results of challenge exposure animals with reactions/ tested animals |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (respiratory sensitising) based on GHS criteria
- Conclusions:
- The test item showed a potential for respiratory sensitisation in guinea pigs. The substance is classified as Category 1 according to CLP criteria.
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