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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
The oral repeated dose toxicity study was performed according to OECD Guideline 407 and GLP principles. In addition, an oral OECD421 study is available showing parental effects in Wistar Han rats at the highest dose tested, while the OECD 407 study in Sprague-Dawley rats did not show these effects. Therefore, the lowest NOAEL is used for risk assessment.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study has a reliability 1.
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
Sprague Dawley rats were given 50, 250 or 1000 mg/kg bw/d of B508 in 0.5 w/v% methylcellylose by gavage according to OECD 407 (2008) and GLP principles.No mortality and no adverse clinical signs occurred. No effects were observed on body weight, food consumption, functional behaviour, haematology and clinical chemistry parameters, urinalysis, organ weights, gross- and histopathology. Therefore, the NOAEL was established to be >= 1000 mg/kg bw/d.
B508 was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 0, 50, 250 and 1000 mg/kg body weight/day according to OECD 421. Males were exposed for 28 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 40 to 49 days, i.e. during 2 weeks prior to mating, during mating, duringpost-coitum, and during at least 3 days of lactation.
There were no treatment-related changes for mortality, clinical signs, body weight, food consumption, or organ weights. At macroscopy yellowish-greenish soft nodules were noted in the epididymides (tail), which correlated with an increased incidence and severity of sperm granulomas in the epididymides observed at 1000 mg/kg bw/d at microscopic examination leading to a parental NOAEL of 250 mg/kg bw/d.
The oral OECD421 study available shows parental effects in Wistar Han rats at the highest dose tested, while the OECD 407 study in Sprague-Dawley rats did not show these effects. Therefore, the OECD421 study is currently used as key study for risk assessment purposes.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Two key studies are available, the key study with the lowest NOAEL is selected.
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: epididymides
Justification for classification or non-classification
Based on the studies available no classification is needed for repeated dose toxicity according to EC regulation 1272/2008.
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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