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EC number: 268-582-0 | CAS number: 68130-25-6
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Type of composition:
- legal entity composition of the substance
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Reference substance:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence
The test item attained 62% biodegradation at 28 days. Under the strict terms and conditions of OECD Guideline No. 301B the test item cannot be considered to be readily biodegradable as the test item failed to satisfy the 10-Day window validation criterion, whereby 60% biodegradation must be attained within 10 days of the biodegradation exceeding 10%.
According to the CLP criteria if a substance is identified as a UVCB substance or as a complex, multi- constituent substance with structurally similar constituents and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days. (CLP Annex 1- 4.1.2.9.5)
Test item H-32 is considered as a UVCB substance where all components are structurally similar and study data confirms H-32 did achieve greater than 60% biodegradation within the 28-day time period. On this basis H-32 can be considered as readily biodegradable.
Further evidence to support biodegradation is predictions using the BIOWIN models
1, 2, 3, 5 and 6. According to the Biowin helpfile, the criteria for an overall YES or NO prediction are as follows: If Biowin 3 (ultimate survey model) result is “weeks” or faster (e.g. days or days to weeks) AND Biowin5 (MITI linear model) is readily biodegradable, then the prediction is YES(readily biodegradable). (Chapter R-7b endpoint specific guidance)
For test item H-32, the result under Biowin model 3 is “days-weeks” and the result under Biowin 5 is readily biodegradable. Results are attached in section 13 of the dossier.
Based on all available data listed above biodegradation is confirmed and it may be concluded that the substance does not possess P or vP properties
Bioaccumulation
Experimentally derived Log Kow was found to be 6.5 therefore on the basis of the screening criteria it must be considered that the substance could possess B or vB properties, although no data are currently available to confirm this conclusion.
Toxicity
The substance is also considered non toxic as none of the available data indicates toxic properties. For mutagenic effects all three in-vitro genetic toxicity studies (Mouse lymphoma assay, Chromosome Aberration and Ames) were all concluded with a negative result therefore indicating that the substance in unlikely to cause mutagenic activity in the absence or presence of metabolic activity.
There are no carcinogencity data available however in the absence of genetic toxicity as noted above it is considered that there is no concern for carcinogenic effects..
In the reproductive toxicity screening study no reproductive effects were seen and no development effects were seen in the absence of possible toxic effects seen in maternal animals. Also no toxicity was seen in the 28 day repeated dose oral toxicity study.
Reference
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.