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Diss Factsheets
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EC number: 247-668-1 | CAS number: 26402-26-6
- 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
- Study period:
- The test will be conducted after a final decision on the requirement to carry out the proposed test has been taken and a deadline to submit the information required has been set by the Agency.
- 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: octanoic acid, monoester with glycerol
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing prenatal developmental toxicity in the rat are available with the registered substance.
- Available non-GLP studies: No non-GLP studies addressing prenatal developmental toxicity in the rat are available with the registered substance.
- Historical human/control data: Historical human data is not available.
- (Q)SAR: The available Q(SAR) methods are not applicable as none of the methods will assess the full scope of prenatal developmental toxicity.
- In vitro methods: No validated in vitro methods to assess prenatal developmental toxicity are available.
- Weight of evidence: There is no information (QSAR, in vitro data, developmental toxicity or fertility data) available that is suitable to assess the prenatal developmental toxicity potential in the rat in a weight of evidence approach.
- Grouping and read-across: There is no data available for suitable source substances addressing prenatal developmental toxicity in the rat.
- Substance-tailored exposure driven testing: This option is not relevant.
- Approaches in addition to above: There are no known alternative approaches to meeting the data requirements according to Annex IX of the REACH Regulation (EC) No. 1907/2006.
- Other reasons: There are no known alternative approaches to meeting the data requirements according to Annex IX of the REACH Regulation (EC) No. 1907/2006.
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:
- The prenatal developmental toxicity study in a first species is a standard information requirement under Annex IX of the REACH Regulation (EC) No. 1907/2006. There is no guideline-compliant data available on prenatal developmental toxicity with the registered substance or suitable source substances. Validated or regulatory accepted alternative methods are not available for replacing animal testing with respect to prenatal developmental toxicity.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: A Prenatal Developmental Toxicity study (OECD TG 414) by oral route will be conducted in the rat with octanoic acid, monoester with glycerol (CAS 26402-26-6, EC 247-668-1).
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Octanoic acid, monoester with glycerol
- EC Number:
- 247-668-1
- EC Name:
- Octanoic acid, monoester with glycerol
- Cas Number:
- 26402-26-6
- Molecular formula:
- C11H22O4
- IUPAC Name:
- 1,3-dihydroxypropan-2-yl octanoate; 2,3-dihydroxypropyl octanoate
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.