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EC number: 695-988-9 | CAS number: 100556-82-9
- 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
Endpoint summary
Administrative data
Description of key information
No adverse effects observed after repeated administration.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1965
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Rather old study without sufficient information; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form
- Principles of method if other than guideline:
- Internal Guideline Hoechst AG
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: mixed racial albino rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 90 to 124 g
- Fasting period before study: none
- Housing: group-housing: 5 rats per sex and cage
- Diet (e.g. ad libitum): Standard Altromin (Altrogge)
- Water (e.g. ad libitum): tap water
- Acclimation period: NA - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
5% solution in water
VEHICLE
- Justification for use and choice of vehicle (if other than water): -
- Concentration in vehicle: 5% (50 mg/mL)
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- -
- Duration of treatment / exposure:
- 14 treatments within 21 days (5 days/week)
- Frequency of treatment:
- 14-times on weekdays
- Remarks:
- Doses / Concentrations:
500 mg/kg bw/day
Basis:
nominal in water - Remarks:
- Doses / Concentrations:
50 mg/mL
Basis:
nominal in water - No. of animals per sex per dose:
- 10
- Control animals:
- other: comparison to pre-treatment data
- Details on study design:
- Post-exposure period: 3 days
- Positive control:
- NA
- Observations and examinations performed and frequency:
- Body weight: weekly
Clinical signs: daily
Urine: appearence, color, protein, sediment in 5 rats/sex beginning and end of study
Hematology: hemoglobin, erythrocyte count, leukocyte count, differential blood cell count in 5 rats/sex beginning and end of study - Sacrifice and pathology:
- Sacrifice: cervical dislocation and exsanguination
Necropsy: macroscopic evaluation
organ weights: heart, lung, liver, kidney, spleen
microscopic examination: heart, lung, liver, kidney, adrenal, spleen - Other examinations:
- behavior
- Statistics:
- no data
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- urine and feces stained by test article
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: urine and feces stained by test article
- Critical effects observed:
- not specified
- Conclusions:
- No adverse effects were observed at 500 mg/kg/day.
NOEL: 500 mg/kg/day in male and female rats - Executive summary:
10 mixed race albino rats per sex received 500 mg/kg bw Remazolschwarz B 14-times in 21 days orally by gavage, followed by a 3-day post-observation time. There were no adverse effects observed in clinical signs, body weight development, urinalysis, hematology, marco- and microscopic evaluation. The test item was excreted via feces and urine.
The No Observed Effect Level is 500 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A 21-day study with 14 applications of Reactive Black 5 was performed with a single dose of 500 mg/kg bw/day was performed without revealing any adverse effects. The only effects seen were substance stained urine and faeces.
The subacute oral toxicity study (28 applications within 29 days) with the structural analogue 01 produced the following effects; faeces of animals of the 1000 mg/kg test group were red discoloured, beginning with day 6. Urine was red-brown discoloured in all animals of the 1000 mg/kg test group. Necropsy revealed red discoloration of the kidneys in all animals of the 1000 mg/kg test group. Additionally, the testes of the male animals were red discoloured. Vacuolization of the epithelial cells of the renal cortex was microscopically observed in two female animals of this test group, which are considered to be a result of an increased reabsorption and subsequent deposition of the test compound. Summarising, the 29-day oral administration of the substance at a dose of 1000 mg/kg body weight/day resulted in two female animals in microscopic renal findings as described above. There was no evidence in clinical chemistry and histopathology of an adverse effect on the renal function. The administration of the test compound in a dose of 1000 mg/kg body weight/day did not induce any evident relevant compound-related changes in male animals. The NOAEL was therefore considered to be 1000 mg/kg bw/day in male and female rats. With regard to the present study the No Observed Effect Level (NOEL) is 1000 mg/kg body weight/day for male and 250 mg/kg body weight day for female animals due to dye re-absorption in two females. There was no clear evidence of a toxic effect in female animals even after administration of 1000 mg/kg body weight/day.
Justification for classification or non-classification
Based on the findings of the repeated dose toxicity study, the test substance does meet the criteria of the Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and therefore no classification is needed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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