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EC number: 800-766-3 | CAS number: 1424148-97-9
- 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)
Description of key information
No experimental data investigating the toxicokinetic profile is available.
Based on the evidences from the toxicity studies no bioaccumulation potential can be derived.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Assessment on the toxicokinetic profile of the registration substance
The registration substance is a salt of a weak acid and is expected dissociate immediately when dissolved in aqueous system or in biological fluid. It should be mentioned here, that manufacture and use of the registration substance occurs only as dissolved in aqueous system. Therefore, the chemical species relevant for the uptake and the systemic burden is also the acid form. Accordingly the bioaccumulating potential of (Pentapropenyl succinimido)-caproic acid, the acid form of the registration substance, will be assessed.
No experimental data investigating the toxicokinetic property of (Pentapropenyl succinimido)-caproic acid is available.
The assessment will be performed based on the following data:
- combined repeated dose toxicity with reproductive/developmental toxicity screening study on (Pentapropenyl succinimido)-hexanoate, sodium and triethanolamine salts;
-28-day study on the read-across substance (Tetrapropenyl succinimido)-caproic acid;
- chemical structure and liphophilicity;
- cytotoxicity data obtained in the preliminary studies in in-vitro genotoxicity studies on the reac-across substance (Tetrapropenyl succinimido)-caproic acid;
- BCF study in fish on the read-across substance (Tetrapropenyl succinimido)-caproic acid (endpoint study record provided under IUCLID chapter 5.3.1 / CSR chapter 4.3.1)
The justification for the read-across is provided and is not further mentioned here. The discussion will be focused on the indications relevant for the bioaccumulating potential assessment.
Considering that the (Pentapropenyl succinimido)-caproic acid is soluble in octanol and is of molecular mass of 420 g/mol, it can be reasonably derived that the substance will be readily adsorbed and distributed via lymphatic tissues. The given LogPow of > 3 is indicative that the elimination as unchanged molecule is not likely to occur. Two cases can be imagined: the degradation is not efficient and the internal burden increases with increasing exposure duration vs. the degradation is efficient and the internal burden is less dependent on the exposure duration. The second case corresponds to “no bioaccumulating potential”.
The structural feature of N-alkylated imide in the center of molecule and highly branched alkenyl moiety imply a certain degree of reluctance to undergo degradation process. A metabolic overload can be predicted unless there is no metabolism. In the available two mid-term studies, the liver was identified as the target organ and the observed alteration pattern of the findings (liver weight increase, hepatocellular hypotrophy) is indicative of adaptation/metabolic overload/functional impairment. These effects in liver disappeared completely within the recovery period of 14 days, indicating that the chemical burden must have decreased rapidly with cessation of treatment. An extensive metabolism can be derived.
Further support is given in the preliminary cytotoxicity study in in-vitro genotoxicity studies. The cytotoxicity with S9-mix was significantly reduced when compared to that of without S9-mix. The fact that the metabolic activation by action of liver enzymes is associated with detoxification implies that the liver is likely to serve as the detoxification organ under in-vivo condition.
Besides of toxicity studies, the no bioaccumulating potential/extensive metabolism can also be derived from the result obtained in the bioconcentration study in fish. The BCF in fish bioaccumulation study was< 158 at concentration of 0,06 mg/l. Assuming that the substance is readily bioavailable, and the LogPow is indicative of no elimination as unchanged molecule, the obtained low BCF value is demonstrative of an efficient elimination in fish.
Combining all available evidences, it can be concluded that an extensive metabolism occurs in the liver. Based on the general rule of the biotransformation, the most likely degradation pathway is the ß-oxidation of N-alkyl chain, followed by the hydrolysis at the imine/imide moiety. The resulting metabolite, highly branched alkenyl-succinic acid, could undergo urinary excretion either as it is, or conjugated.
In conclusion, no bioaccumulating potential can be derived.
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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