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EC number: - | CAS number: -
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 2,1993 to February 24,1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of disodium 6-acetamido-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2-sulfonate and sodium 6-acetamido-4-hydroxy-3-{[4(vinylsulfonyl)phenyl]diazenyl}naphthalene-2-sulfonate
- Molecular formula:
- n.a.
- IUPAC Name:
- Reaction mass of disodium 6-acetamido-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2-sulfonate and sodium 6-acetamido-4-hydroxy-3-{[4(vinylsulfonyl)phenyl]diazenyl}naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Strain: Hoe: WTSKf(SPF71)
- Age at study initiation:male 8 weeks, females 7 weeks
- Weight at study initiation:
males (x)= 184 g s=±6 g xmin=176 g (-4.4%) xmax= 193 g (+4.8%)
females (x)= 166 g s=±5 g xmin=160 g (-3.7%) xmax= 174 g (+4.8%)
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment.
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at extensive identical conditions)
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±20%
- Photoperiod: 12 hours cycle dark/light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% suspension, 10 ml/kg bw
PREPARATION OF THE SUBSTANCE
- Remazol-Brillantorange 3R was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. Stability and homogeneity of the test substance was determined by analytical methods. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 x sex x dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice every day
- Necropsy of survivors performed: yes, at the end of the observation period the animais were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight,organ weights.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after application of 2000 mg/kg body weight. Feces and bedding were discoloured reddish at the first day of the study.
- Gross pathology:
- The animals kilied at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute oral toxicity testing of Reactive Orange 16 in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. No deaths occurred during the whole study.
- Executive summary:
Acute oral toxicity testing of Reactive Orange 16 in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. in both male and female animals. After application of 2000 mg/kg b.w. neither deaths nor symptoms occurred. Feces and bedding were discoloured reddish at the first day of the study. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.
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