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Diss Factsheets
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EC number: 941-267-1 | CAS number: 1445870-18-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
Hexanoic acid, 3,5,5-trimethyl-, 2,2,6,6-tetramethyl-1-[2-[(3,5,5-trimethyl-1-oxohexyl)oxy]ethyl]-4-piperidinyl ester
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Available GLP studies are part of the registration dossier. A GLP-compliant combined repeated dose toxicity / screening for reprotoxicity study according to OECD TG 422 in rats after oral administration is available. However, this data do not fulfil the requirements of a full prenatal developmental toxicity/teratogenicity study in rodents according to OECD TG 414.
- Available non-GLP studies: There are no non-GLP studies regarding the endpoint developmental toxicity/teratogenicity.
- Historical human/control data: Databases containing potential information on developmental toxicity/teratogenicity of the substance in published and internal data on the substance were searched and no contributing information was found.
- (Q)SAR: There are no QSAR models that allow a reliabe and adequate prediction of the potential of developmental toxicity/teratogenicity. Therefore, animal testing can not be replaced.
- In vitro methods: There are no in vitro methods that allow a reliabe and adequate prediction of the potential for developmental toxicity/teratogenicity.
- Weight of evidence: Considering the lack of in-vitro methods, QSAR models and prenatal developmental toxicity/teratogenicity studies on the substance itself and potential analogues, a weight-of-evidence assessment is not possible.
- Grouping and read-across: Since none of potential candidates for read-across has been tested for developmental toxicity/teratogenicity in rodents according to OECD TG 414, read-across is not possible.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: not applicable
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Based on the existing data and hazard and use profile of the substance in question, it is not possible to apply specific adaptation possibilities listed in Annexes IX and X. Thus, a GLP-compliant developmental toxicity study in the rat via the oral route following OECD TG 414 is proposed.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: A standard OECD 414 guideline study is proposed.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate
- EC Number:
- 941-267-1
- Cas Number:
- 1445870-18-7
- Molecular formula:
- C29H55NO4
- IUPAC Name:
- 2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
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.