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EC number: 278-108-4 | CAS number: 75199-00-7
- 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:
- 1990-05-07 to 1990-07-05
- 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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The method is based on 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 is 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:
- Trisodium 4-[[4-[[(2,3-dichloro-6-quinoxalinyl)carbonyl]amino]-2-sulphonatophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazole-3-carboxylate
- EC Number:
- 278-108-4
- EC Name:
- Trisodium 4-[[4-[[(2,3-dichloro-6-quinoxalinyl)carbonyl]amino]-2-sulphonatophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazole-3-carboxylate
- Cas Number:
- 75199-00-7
- Molecular formula:
- C25H15Cl2N7O10S2.3Na
- IUPAC Name:
- trisodium 4-[(E)-2-[4-(2,3-dichloroquinoxaline-6-amido)-2-sulfophenyl]diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylate
- Test material form:
- solid: granular
- Details on test material:
- Reactive Yellow 27
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Prirbright-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: 310 ± 20 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
Test system
- Route of induction exposure:
- intradermal
- Route of challenge exposure:
- inhalation
- Vehicle:
- water
- Remarks:
- for intradermal injection
- Concentration:
- intradermal induction: 5% test item in water
challenge: 45 mg/m³ - No. of animals per dose:
- 8
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 times intradermal application: two applications, each of 100 µL
- Test groups: two applications of 100 µL
- Control group: two applications of 100 µL water
- Site: on the flank; Day 0: cranial, Day 2: thoracal, Day 4: caudal
- Frequency of applications: every second days
- Duration: 4 days
- Concentrations: 5% suspension of the test item in water
B. CHALLENGE EXPOSURE
- No. of exposures: 2 à 30 min
- Day(s) of challenge: 2
- Exposure period: day 21 to 24
- Site: head-nose exposition
- Concentrations: 45 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
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.
Challenge: Some animals showed difficult breathing during and/or after the challenge phase. This partial marginal effects are not given any patho-diagnostic relevance, since corresponding reactions have also been identified in the control animals. See also table 2 in "Any other information on results incl. tables".
Lung function tests: The test item showed no sensitising potential in lungs.
Body weight: There were no changes in body weights observed.
Gross pathology: No test item-related effects.
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 | Anaphylaxis | Immediate | Delayed |
Vehicle | 0/8 | (1)/8 | (4)/8 |
Test item | 0/8 | (1)/8 | (2)/8 |
1st number: animals tested positive
2nd number: number of exposed animals
Some animals showed laboured respiration during and/or after the challenge phase. These partial marginal effects are not given any patho-diagnostic relevance, since corresponding reactions have also been identified in the control animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the test item showed no sensitising potential in lungs of guinea pigs.
- Executive summary:
In a respiratory sensitization study with the test item, young adult Pirbright-White-Dunkin-Hartley guinea pigs (8 females/group) 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. 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.
No effects in body and lung weights were observed compared to the control. No gross pathological findings were observed.
During and after the challenge phase some animals showed difficult breathing. Since corresponding reactions have also been identified in the control animals, the partial marginal effects are not given any pathodiagnostic relevance.
According to this study, the test item is not a respiratory sensitizer, which might be attributable to the barely respirable particles.
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