Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 437-450-6 | 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: written assessment
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A written assessment of toxicokinetic behaviour is considered appropriate for the substance.
- Conclusions:
- In conclusion, there is no evidence that would suggest that C10-13 Branched alkyl-N-(naphthyl) aniline absorbed via the dermal route and the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. The substance is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues the substance may then accumulate in individuals that are frequently exposed to that substance. However once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance. Metabolism prior to absorption may occur by gut microflora or enzymes in the GI mucosa. Since substances that enter the blood at this point pass through the liver before entering the systemic circulation, hepatic first pass metabolism may limit the amount of parent compound that enters the systemic circulation. The substance would then be expected to be excreted in the faeces alongside the metabolites of N-1-naphthylaniline, glucuronide and sulphites.
Based on the physicochemical properties of the substance low bioaccumulation would be expected. - Executive summary:
In conclusion, there is no evidence that would suggest that C10-13 Branched alkyl-N-(naphthyl) aniline absorbed via the dermal route and the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. The substance is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues the substance may then accumulate in individuals that are frequently exposed to that substance. However once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance. Metabolism prior to absorption may occur by gut microflora or enzymes in the GI mucosa. Since substances that enter the blood at this point pass through the liver before entering the systemic circulation, hepatic first pass metabolism may limit the amount of parent compound that enters the systemic circulation. The substance would then be expected to be excreted in the faeces alongside the metabolites of N-1-naphthylaniline, glucuronide and sulphites.
Based on the physicochemical properties of the substance low bioaccumulation would be expected.
Reference
Description of key information
In conclusion, there is no evidence that would suggest that C10-13 Branched alkyl-N-(naphthyl) aniline absorbed via the dermal route and the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. The substance is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues the substance may then accumulate in individuals that are frequently exposed to that substance. However once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance. Metabolism prior to absorption may occur by gut microflora or enzymes in the GI mucosa. Since substances that enter the blood at this point pass through the liver before entering the systemic circulation, hepatic first pass metabolism may limit the amount of parent compound that enters the systemic circulation. The substance would then be expected to be excreted in the faeces alongside the metabolites of N-1-naphthylaniline, glucuronide and sulphites.
Based on the physicochemical properties of the substance low bioaccumulation would be expected.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
As a worst case scenario the oral, dermal and inhalation absorption rate has been set to the default value of 100%
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.