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EC number: 280-426-3 | CAS number: 83400-11-7
- 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:
- 1990-10-15 to 1991-01-18
- 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 method is based according to Karol et al. 1985, Karol et al. 1978, DeCeaurriz et al. 1987, Barrow et al. 1977, Botham et al. 1988, Botham et al. 1989.
The exposure criteria are according to OECD 403. The corresponding EC directive is fulfilled as far as it relevant for this type of study. General recommendations on the measurement technique (ASTM E 981-84, ALARIE, 1973) were taken into account. - GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt
- EC Number:
- 280-426-3
- EC Name:
- 4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt
- Cas Number:
- 83400-11-7
- Molecular formula:
- C32 H21 Cl F2 N6 O11 S3 . x Li . x Na C32H(21-x-y)ClF2Li(x)N6Na(y)O11S3
- IUPAC Name:
- 4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 1-2 months
- Weight at study initiation: 245 ± 16 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
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least one week
- Indication of any skin lesions: only health and symptom free animals were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): ca. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Route of induction exposure:
- intradermal
- Route of challenge exposure:
- inhalation
- Vehicle:
- water
- Remarks:
- levatit water
- Concentration:
- intradermal induction: 5% test item in water
- No. of animals per dose:
- 8
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 times intradermal application, 2 applications, each of 100 µL (Monday (day 0): cranial, Wednesday: thoracal, Friday: caudal)
- Test groups: 100 µL of 5% test item in water, two applications
- Control group: 100 µL water, two applications
- Site: on the flank, Day 0: cranial, Day 2: thoracal, Day 4: caudal
- Concentrations: 5% solution of the test item in water.
B. CHALLENGE EXPOSURE
- No. of exposures: single exposure for 30 min with the aerosol
As only 4 animals could be exposed simultaneously control group (1a) was exposed on day 21, control group (2a) was exposed on day 22, test item group (1b) was exposed on day 23 and test item group (2b) was exposed on day 24.
The exposure concentrations were: 1a: 26 mg/m³, 2a: 28 mg/m³, 1b: 24 mg/m³ and 2b: 29 mg/m³
- Evaluation: Lung function: peak expiratory flow (PEF), respiratory rate volume (TV), respiratory rate per minute (RR), respiratory minute volume (MV), inspiration time (IT), expiration time (ET)
OTHER:
Body weights:
Body weights were taken befor the 1st application, on day 3 and 7 afterwards once per week
Clinical Signs:
Animals were observed at least once per day
Necropsy:
On day 25 the animals were sacrificed and analysed by gross pathology. The weight of the lung were taken. - Challenge controls:
- yes
- Positive control substance(s):
- none
- Negative control substance(s):
- none
Results and discussion
- Results:
- Induction:
No test item-related effects; but local skin reactions at the injection site (encrusted and hardened skin)
Challenge:
no clinical effects
Lung function tests:
In 3 of 8 exposed animals effects of pulmonary hypersensitivity were observed. This was characterized by a modified respiratory minute volume and a disproportionate increase in the expiratory time. Delayed pulmonary reactions were observed in 4 of 8 animals.
Body weight:
There were no changes in body weights observed.
Gross pathology:
No effects were observed in any animals.
Lung weights:
No changes in lung weights were observed in any animals. - Positive control results:
- n.a.
- Negative control results:
- No effects were observed in vehicle control animals.
Any other information on results incl. tables
Table 2: Number of Animals with positive reaction during challenge phase
Induction | Anaphylaxie | Immediate | Delayed |
Vehicle | 0/8 | 0/8 | 0/8 |
Test item | 0/8 | 3/8 | 4/8 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (respiratory sensitising) based on GHS criteria
- Conclusions:
- In this study, the test item showed a sensitising potential in lungs of guinea pigs.
- Executive summary:
In a respiratory sensitization study with the test item, young adult female Pirbright-White-Dunkin-Hartley guinea pigs (8/group) were tested for respiratory sensitisation. The animals were treated intradermally with the test item 5% in water. After three weeks the control and test item group animals were challenged with a 30 min inhalation exposure with the test item. In 3 of 8 exposed animals effects of pulmonary hypersensitivity were observed. Delayed pulmonary reactions were observed in 4 of 8 animals. No effects in body and lung weights were observed compared to the control. No gross pathological findings were observed. According to this study, the test item is a respiratory sensitizer.
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