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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
One key study on acute oral toxicity according to OECD 423 is available.
One key study on acute inhalation toxicity according to OECD 403 is available.
One key study on acute dermal toxicity according to OECD 402 is available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study has a reliability 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 000 mg/m³
- Quality of whole database:
- The study has a reliability 1.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study has a reliability 1.
Additional information
Acute oral:
B508 was administered by oral gavage to two subsequent groups of three females Wistar rats at 2000 mg/kg bw according to OECD 423 guideline and GLP Principles.
No mortality occurred. Hunched posture was noted in all animals and had resolved within 2 or 4 hours post-treatment. No effect on body weight gain was observed. No macroscopic abnormalities were found. The oral LD50 value of B508 was established to exceed 2000 mg/kg bw.
Acute inhalation:
B508 was administered by inhalation for 4 hours at a limit concentration to rats according to OECD 403 guideline and GLP Principles.
The actual concentration of 4.0 ± 0.8 mg/L was the maximum attainable concentration which could be generated in air for 4 hours.
One male was found dead approximately 2½ hours after initiation of exposure. Clinical signs included hunched posture, lethargy, laboured respiration, irregular breathing and rales. Body weight loss was shown by all survivors during the first week after exposure only. No abnormality was found at macroscopic post mortem examination of the animal that died during the study. Macroscopic post mortem examination of the surviving animals at termination revealed many bluish foci in the lungs of all animals and bluish discolouration of the skin of the tail.
The inhalatory 4 -hour LC50 of B508 in rats was found to exceed the maximum attainable concentration of 4.0 mg/L. Although one mortality was observed at this exposure level and clinical signs indicative of respiratory difficulties (laboured respiration and rales) were noted during a significant part of the observation period, it was considered that the 4-hour LC50 of B508 exceeds 5 mg/L.
Acute dermal:
B508 was administered to rats by a single dermal application at 2000 mg/kg bw for 24 hours according to OECD 402 guideline and GLP Principles.
No mortality occurred. No adverse clinical signs were observed. No effect on body weight gain after patch removal was noted. No macroscopic abnormalities were observed.The dermal LD50 of B508 in rats was established to exceed 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
One key study is available.
Justification for selection of acute toxicity – inhalation endpoint
One key study is available.
Justification for selection of acute toxicity – dermal endpoint
One key study is available.
Justification for classification or non-classification
Based on the results mentioned above, B508 does not have to be classified and has no obligatory labelling requirement for acute oral, dermal or inhalation toxicity in accordance with Regulation EC No. 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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