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EC number: 274-700-1 | CAS number: 70616-89-6
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- year 1981
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
- EC Number:
- 233-311-7
- EC Name:
- Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
- Cas Number:
- 10114-47-3
- Molecular formula:
- C28H20N4O6S4.2Na
- IUPAC Name:
- disodium 2,2'-(diazene-1,2-diyldi-4,1-phenylene)bis(6-methyl-1,3-benzothiazole-7-sulfonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: orange powder- Batch No.: 31/94- Prevailing particle size: 2 - 4 µm
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: breeding farm Velaz Praha- Females (if applicable) nulliparous and non-pregnant: yes- Age at study initiation: 8 weeks- Weight at study initiation: 177.2 g (male, average), 173.2 (female, average)- Diet (e.g. ad libitum): granulated feed mixture ALTROMIN 1320 12 g/animal/day- Water (e.g. ad libitum): tap waster ad libitum- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature: 22 ± 3°C - Humidity: 40 - 60 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Remark on MMAD/GSD:
- Particle size distribution:1 - 4 µm: 76.29 %4 - 10 µm: 17.29 %10 - 20 µm: 5.20 %above 20 µm: 1.21 %
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION - Method of holding animals in test chamber: head only - Source and rate of air: 10 l/min - System of generating particulates/aerosols: Vright Dust Feed Unit MK2, GA 4170, L. Adams ltd., London - Temperature, humidity, pressure in air chamber: temperature 22°C, humidity 55 %, negative pressure 98 Pa TEST ATMOSPHERE - Brief description of analytical method used: Samples of the atmosphere from the inhalation chamber were collected at a rate 4 l/min; 10 liters of air was taken in total. The collected air passed through the filter cartridge and the concentration of the test substance was determined gravimetrically. VEHICLE - Vehicle: air - Concentration of test material in vehicle (if applicable): 4.97 mg/l
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 4.97 mg/l
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: observation 1 and 2 hours after ending of the exposure, then once a day; body weight on day 0, 7 and 14 - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ weights
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- not observed
- Clinical signs:
- other: During exposure: orange discharge from the nasal cavity, motor disorders of the body, limbs or tail have not been observedPost exposure period:- 0, 60 and 120 min: piloerection, orange discharge from the nasal cavity, regular breathing 110 - 120 per minut
- Body weight:
- Average body weight: Treated group:- day 0: 177.2 g (M), 173.2 g (F)- day 7: 181.6 g (M), 175.2 g (F)- day 14: 186.8 g (M), 186.8 g (F) Control group:- day 0: 172.7 g (M), 166.7 g (F)- day 7: 173.3 g (M), 198.0 g (F)- day 14: 188.3 g (M), 208.6 g (F)
- Gross pathology:
- Pathological examination did not reveal any general or focal pathology changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- For Reactive Orange 13, a limit test for acute inhalation toxicity was performed. The test was performed according to the OECD TG 403 methodology. The experimental animals (rats) were exposed to inhalation of the test substance powder in air for 4 hours in a “head-only” inhalation chamber. Actual concentrations of the test substance were determined gravimetrically. Prior to exposure, the particle size was measured microscopically; majority size was in the range of 1-4 μm.During the exposure and during the 14-day observation period there was no death of the test animals.Clinical disorders of the health of the test animals may be considered as a consequence of mechanical irritation of the upper respiratory tract.The results of the limit test did not reveal any adverse effect on the health of the experimental animals.
- Executive summary:
For Reactive Orange 13, a limit test for acute inhalation toxicity was performed. The test was performed according to the OECD TG 403 methodology. The experimental animals (rats) were exposed to inhalation of the test substance powder in air for 4 hours in a “head-only” inhalation chamber. Actual concentrations of the test substance were determined gravimetrically. Prior to exposure, the particle size was measured microscopically; majority size was in the range of 1-4 μm.
During the exposure and during the 14-day observation period there was no death of the test animals.
Clinical disorders of the health of the test animals may be considered as a consequence of mechanical irritation of the upper respiratory tract.
Pathological examination revealed the penetration of the test substance into the lung tissue in two males. Mild pulmonary congestion probably was caused due to circulation changes in the euthanasia of animals.
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