Registration Dossier
Registration Dossier
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Diss Factsheets
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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
Key value for chemical safety assessment
Additional information
Justification for the read-across approach using (Tetrapropylensuccinimido)-caproic acid as supporting substance:
The acid form of the registration substance and proposed supporting substance (Tetrapropylensuccinimido)-caproic acid are homolog series of (Polypropylensuccinimido)-caproic acid. The only structural difference is that the alkyl moiety of the registratoin substance is composed of five propylen unit, whereas that of the supporting substance is composed of four propylen unit. The given structural difference is not likely to be associated with significantly deviating genotoxicity potential, because significantly different chemical reactivities cannot be expected.
Evaluation of the genotoxicity of the registration substance
The read-across supporting substance is not mutagenic in Ames test, not mutagenic in HPRT test. It is however clastogenic in in-vitro chromosome aberration test and not clastogenic in in-vivo chromosme aberration test.
The observed clastogenicity in in-vitro assay may be related to the highly branched alkyl moiety that may be able to form stabilized radical species. This property is certainly linked to the technical profile in that the substance is used as corrosion inhibitor. In the in-vivo chromosome aberration assay no clastogenic acitivity was found in the bone marrow of orally treated animals. The study is valid, since cytoxicity was found in the bone marrow cells, demonstrating that the bioavailbility to the bone marrow cells was given. Overall, no significant genotoxicity can be assigned for the read-across supporting substance based on the available data.
Likewise no significant genotoxicity property can be derived for the registration substance.
Justification for selection of genetic toxicity endpoint
Four studies are available and all studies are equally valid.
Short description of key information:
No significant genotoxicity property can be derived for the registration substance.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The overall genotoxicity is assessed to be of no concern.
No classification is warranted.
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.