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EC number: 432-690-8 | 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Expert opinion
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The expert opinion is based on the available information on the physical, chemical and toxicological properties of the test material
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
- Objective of study:
- other: Assessment of toxicokinetic behaviour
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- no
Test material
- Details on test material:
- Data evaluation included substance data as well as on analogue substances
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- No treatment related effects were seen in an acute oral toxicity study on the notified substance or in an acute dermal study conducted on the analogue substance 1 (refer to IUCLID chapter 13). In a repeated dose oral toxicity study conducted on the analogue substance 1 (refer to IUCLID chapter 13), however, treatment related kidney changes were observed, which indicate that absorption could occur from the gastro-intestinal tract. The notified substance has a low log Pow value, which suggests poor absorption by passive diffusion, but it is very water soluble and may therefore show higher lipid solubility than is suggested by the Pow value. Any absorption would be expected to be pH dependant since the notified substance is a polybasic salt of both weak and strong acid groups. Absorption would, therefore, be favoured in the acid environment of the stomach, whilst interaction with counter ions could, potentially, increase lipophilicity.
- Details on distribution in tissues:
- There is no experimental evidence to indicate potential distribution of any absorbed substance, other than to the route of excretion. Bioaccumulation is probably unlikely, in view of the high water solubility. A contact sensitisation study conducted on the analogue substance 1 (refer to IUCLID chapter 13) was negative, which might imply that the substance would not be expected to bind to proteins.
- Details on excretion:
- The kidney effects seen in the repeated dose oral toxicity study conducted on the analogue substance 1 (refer to IUCLID chapter 13) suggest that excretion in urine occurs. The water solubility of the parent substance and the possible metabolites indicate this to be the most likely route of excretion, although high molecular weight substances are sometimes eliminated in bile. The parent substance is not sufficiently volatile for elimination via the lungs in expired air.
Metabolite characterisation studies
- Details on metabolites:
- None of the studies conducted on the notified substance or on the analogue substance 1 (refer to IUCLID chapter 13) provide any convincing information about metabolism. From the chemical structure, enzymatic cleavage might be expected possibly with production of sulfonamides and subsequent conjugation reactions. The high water solubility of the parent substance, however, suggests that excretion may occur without biotransformation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: low bioaccumulation potential based on physico-chemical properties and toxicological studies
The high molecular weight may, theoretically, preclude absorption. No predictions about toxicokinetic behaviour can be made from the chemical structure. The notified substance tested is a powder prepared by drying but will only be used as a solution, so inhalation exposure is not anticipated. It is stable to hydrolysis, so exposure to degradants is not expected. Most of the data used for this assessment is derived from studies conducted on a structurally similar compound the analogue substance 1 (refer to IUCLID chapter 13). 1) ABSORPTION No treatment related effects were seen in an acute oral toxicity study on the notified substance or in an acute dermal study conducted on the analogue substance 1 (refer to IUCLID chapter 13). In a repeated dose oral toxicity study on conducted on the analogue substance 1 (refer to IUCLID chapter 13), however, treatment related kidney changes were observed, which indicate that absorption could occur from the gastro-intestinal tract. The notified substance has a low log Pow value, which suggests poor absorption by passive diffusion, but it is very water soluble and may therefore show higher lipid solubility than is suggested by the Pow value. Any absorption would be expected to be pH dependant since the notified substance is a polybasic salt of both weak and strong acid groups. Absorption would, therefore, be favoured in the acid environment of the stomach, whilst interaction with counter ions could, potentially, increase lipophilicity. 2) DISTRIBUTION There is no experimental evidence to indicate potential distribution of any absorbed substance, other than to the route of excretion. Bioaccumulation is probably unlikely, in view of the high water solubility. A contact sensitisation study conducted on the analogue substance 1 (refer to IUCLID chapter 13) was negative, which might imply that the substance would not be expected to bind to proteins. 3) METABOLISM None of the studies conducted on the notified substance or on the analogue substance 1 (refer to IUCLID chapter 13) provide any convincing information about metabolism. From the chemical structure, enzymic cleavage might be expected possibly with production of sulfonamides and subsequent conjugation reactions. The high water solubility of the parent substance, however, suggests that excretion may occur without biotransformation. 4) EXCRETION The kidney effects seen in the repeated dose oral toxicity study conducted on the analogue substance 1 (refer to IUCLID chapter 13) suggest that excretion in urine occurs. The water solubility of the parent substance and the possible metabolites indicate this to be the most likely route of excretion, although high molecular weight substances are sometimes eliminated in bile. The parent substance is not sufficiently volatile for elimination via the lungs in expired air.
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.

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