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EC number: 270-470-1 | CAS number: 68441-66-7
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Conclusions regarding the toxicokinetic assessment of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) (Hatcol 1106) are based on read-across from analogue substances of a known category. In view of the structural similarities and similar physicochemical properties of the substance of interest with the other substances in the category read across was considered justified.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 100
Additional information
Conclusions regarding the toxicokinetic assessment of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) are based on studies on the substance itself and read-across from analogue substances of a known category. In view of the structural similarities and similar physicochemical properties of the substance of interest with the other substances in the category read across was considered justified.
The water solubility of the substance is very low («1 mg/L). Since in general a compound needs to be dissolved before it can be taken up from the gastro-intestinal tract, it seems unlikely that the substance will show a high systemic exposure after oral administration. However, its highly lipophilic character (log Po/w > 6) indicates that uptake by micellular solubilisation may be of particular importance. For risk assessment purposes oral absorption is set at 100%. The results of the toxicity studies on analogues do not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed, distribution of the substance throughout the body will be limited by low water solubility. Intracellularcentration of the substance is expected to be higher than extracellular concentration, based on its lipophilic character. The concentration in breast milk may be higher than in blood/plasma. As a lipophilic substance, the substance may concentrate in adipose tissue and depending on the conditions of exposure may accumulate. Daily exposure to the substance may result in a build-up in the body. Once exposure stops, the concentration in the body will decline at a rate determined by the half-life of the substance. the substance may be conjugated and excreted via the bile and may also undergo enterohepatic recycling (circulation of bile from the liver, where it is produced, to the small intestine, where it aids in digestion of fats and other substances, back to the liver) which will prolong its biological half-life (2).
The substance has low volatility, i.e., very low vapour pressure ( < 1.33x10-8 Pa at 20°C) and a high boiling point (422°C), and is therefore unlikely to be available for inhalation as a vapour. However, any the substance reaching the respiratory epithelium may be taken up by micellular solubilisation, because of its highly lipophilic character (log Po/w > 6) and low water solubility. For risk assessment purposes the inhalation absorption of the substance is set at 100%.
In view of its highly lipophilic character (log Po/w > 6),and the low water solubility («1 mg/L), the rate of transfer of the substance between the stratum corneum and the epidermis will be slow, and uptake into the stratum corneum itself may be slow. Any substance persisting in the stratum corneum may eventually be cleared as the stratum corneum is sloughed off. A dermal absorption of 10% is proposed for risk assessment purposes.
Absorption rates are justified as follows:
Inhalation
No specific studies on inhalation of the substance itself are available. The substance demonstrated no harmful effects in the toxicity studies, so no conclusions on whether it is absorbed or not can be drawn. 100% inhalation absorption default is assumed in accordance with the guidance.
Dermal
Chapter R.7c: Endpoint specific guidance details as follows:
Substances that can potentially be taken up across the skin include gases and vapours, liquids and particulates. A tiered approach for the estimation of skin absorption has been proposed within a risk assessment framework (EC, 2007): Initially, basic physico-chemical information should be taken into account, i. e. molecular mass and lipophilicity (log P). Following, a default value of 100% skin absorption is generally used unless molecular mass is above 500 and log P is outside the range [-1, 4], in which case a value of 10% skin absorption is chosen (de Heer et al., 1999).
The substance has the following parameters:
MW range of 472 to 1052;
Water solubility: < 1 mg/l.
Log Kow proposed as >6.7.
Taking account of the details within Table R.7.12—3 Interpretation of data regarding dermal absorption, a dermal absorption of 10% is proposed, based on the guidance.
Oral
Chapter R.7c: Endpoint specific guidance details provides various parameters for review when deciding potential oral absorption. Specifically, Table R.7.12—1 Interpretation of data regarding oral/GI absorption provides for various parameters for consideration.
Effects were not noted within the oral dosing studies on the substance, so no conclusions on whether it is absorbed or not can be drawn. However, consideration of Table R.7.12—1 indicates that moderate log P values (between -1 and 4) are favourable for absorption by passive diffusion. Any lipophilic compound may be taken up by micellular solubilisation but this mechanism may be of particular importance for highly lipophilic compounds (log P >4), particularly those that are poorly soluble in water (1 mg/l or less) that would otherwise be poorly absorbed. On this basis, an oral absorption of 100% is proposed for the purposes of assessment as a worst case.
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