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Diss Factsheets
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EC number: 700-571-2 | 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
No biologically or toxicologically relevant findings in a GLP-compliant guideline study up to an oral limit dose of 1000 mg/kg bwt/d
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Results from repeated dose oral toxicity testing of NExBTL renewable diesel indicated negligible effects in male and female Wistar rats following gavage administration of 50, 250 or 1000 mg/kg bwt/d for up to 18 wk. Treatment-related clinical signs were limited to increased salivation following treatment, an observation presumed to reflect the unpleasant taste of the test substance. Observations for neuro-functional and neuro-behavioural toxicity together with determinations of haematological and clinical chemistry parameters were unremarkable. Histopathological findings were limited to an increased occurrence of generalised hepatocyte enlargement (a spontaneous finding, seen occasionally among untreated rats) in females from the high and intermediate dose groups while kidney tissue from high dose males exhibited globular accumulations of eosinophilic material in the tubular epithelium, shown to contain a2-microglobulin (Mallory-Heidenhain staining). The microscopic appearance of a wide range of other tissues was unremarkable. The changes recorded at 1000 and 250 mg/kg/day were considered not to represent an adverse health effect giving a No Observed Adverse Effect Level for systemic and neuro-functional/neuro-behavioural toxicity of 1000 mg/kg/day.
No information is available on the possible effects of repeated dermal or inhalation exposure to NExBTL renewable diesel, however these information requirements are waived in accordance with column 2 of REACH Annex VIII (8.6.1 and 8.6.2). Results from the available repeated dose oral toxicity study described above will be used to derive a NAEL and DNEL for dermal and inhalation exposures.
The study was conducted to achieve compliance under chemical, safety and health regulations other than EU REACH.
Justification for classification or non-classification
No classification required under Directive 67/548/EEC or Regulation EC 1272/2008 for repeated dose toxicity
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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