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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Summary of repeated dose toxicity
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats (Kubaszky, 2011), REACTIVE Blue F08-0170 administered daily by oral gavage to Wistar rats did not result in test item related mortality or clinical adverse effects or changes in the body weight, food consumption, haematology, clinical chemistry, coagulation or urinalysis parameters at dose levels of 25, 150, or 1000 mg/kg bw/day during either the treatment or after a 14-day recovery period. On pathology evaluation of the Main animals, minimal focal reactive hyperplasia of the epithelium in the pyloric glands was noted in 6/12 male and 3/12 female Main High dose 1000 mg/kg bw/day Group 4, but not in 24/24 Mid dose and 8/24 Low dose Main animals, which were evaluated due to macroscopic findings or in the High dose Recovery animals. This microscopic observation was in correlation with dark, diffuse or multifocal, blue or purple, discoloration of the stomach mucosa recorded at these dose levels at necropsy. Following a 14 day recovery period, no test item-related macroscopic or microscopic findings were seen in the 1000 mg/kg bw/day High dose Recovery animals.
During the treatment period, dark blue discoloration of the faeces was noted in the High dose Main animals administered 1000 mg/kg bw/day Reactive Blue F08-0170 starting after the first treatment on Day 0. The discoloration of the faeces persisted in the 1000 mg/kg bw/Day Recovery animals for 3 days after the last dose administration (on Days 42-44); thereafter no test item-related effects were noted until completion of the 14-Day Recovery period. In addition, dark yellow urine was noted at 150 mg/kg bw/day in 5/5 male and 1/5 female Mid dose Main animals and dark blue urine, at 1000 mg/kg bw/day in all High dose Main animals, at urinalysis performed prior to necropsy. These changes were ascribed to elimination of Reactive Blue F08-0170 or its metabolites through faeces or urine and an expected staining effect. Staining of urine also indicates that renal excretion is a relevant pathway for the elimination of REACTIVE BLUE F08-0170.
Under the conditions of this study, the no observed adverse effect level (NOAEL) for REACTIVE BLUE F08-0170 for parental toxicity effects is considered to be 150 mg/kg bw/day based on histopathological changes in the glandular stomach. The effects on the glandular stomach are considered to be caused by adaptive changes in order to absorb and catabolise the dye substance.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach
Justification for classification or non-classification
The above study has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).
The effects on the glandular stomach at 1000 mg/kg bw/day are considered to be caused by adaptive changes in order to absorb and catabolise the dye substance. No classification for prolonged effects is therefore required.
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