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EC number: 953-553-3 | CAS number: -
- 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)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- According to Annex VIII of Reg. (EU) 1907/2006, the toxicokinetic of substance must be assessed from the relevant available information.
No specific studies were available for Fatty acids, C16-C18(even numbered) methyl esters, chlorinated. However, read across of studies on Medium Chain Chlorinated Paraffins/Alkanes, C14-C17, chloro and on Ethyl oleate were carried out.
Based on chemical structure the Medium Chain Chlorinated Paraffins/Alkanes, C14-C17, chloro is produced from C14-C17 alkane via chlorination. The chlorination process will chlorinate C-H bonds more or less randomly, although it is known that the sequence would be to chlorinate each carbon atom in the chain with one chlorine atom before putting a second chlorine atom on a carbon atom which already carries one chlorine atom. The process produces numerous potential isomers and identification of individual isomers is not possible.
Fatty acids, C16-C18(even numbered) methyl esters, chlorinated is produced from C16-C18 methyl esters with a similar randomly chlorination. Fatty acid esters are generally produced by chemical reaction of an alcohol (e.g. methanol) with an fatty acid in the presence of an acid catalyst. Monoesters are the final products of esterification of fatty acids with methanol.
The study on Medium Chain Chlorinated Paraffins/Alkanes, C14-C17, chloro provides insight about how chlorinated products are metabolized into the body, while study on ethyl oleate covers the behavior of Fatty acids esters.
In the gastrointestinal tract and/or livers similar biological processes occurred, enzymatic hydrolysis is the process by which the fatty acids are enzymatically degraded primarily via beta-oxidation. Alternative oxidation pathways (alpha- and omega-oxidation) are available and are relevant for degradation of branched fatty acids. Unsaturated fatty acids require additional isomerization prior to enter the beta-oxidation cycle. The methanol is slowly oxidized in the liver by the enzyme alcohol dehydrogenase (ADH) to formaldehyde, which itself is oxidized very rapidly by the enzyme aldehyde dehydrogenase (ALDH) to formic acid. Finally, formic acid is slowly metabolised to CO2 and H2O.
Data on Medium Chain Chlorinated Paraffins/Alkanes, C14-C17, chloro provide insight about the absorption, tissue distribution and elimination of a14C-labelled C14 -17 chlorinated paraffin (52% chlorinated) after a single oral gavage administration at a dose level of 525 mg/kg bw in male rats.
Radioactivity in blood and plasma, urine and faeces, selected tissues (but not gastrointestinal tract) and residual carcass was determined for up to 89 days post dosing. In animals kept in metabolism cages until termination, the average total recovery of radioactivity from urine, faeces and those tissues and organs sampled was 83.6% of the administered dose. Approximately 70% of the dose was recovered in the faeces and approximately 6% in the urine in the first 4 days after administration. This suggests that only about 30% of the orally administered dose was absorbed by day 4. Radioactivity was still detectable in urine and faeces at the end of the study, suggesting mobilization and excretion from tissue depots. Distribution of radioactivity into the liver and kidney was rapid, with highest levels (1.6 and 0.07% of the dose respectively) seen 24 hours after dosing; whereas distribution into fat and skin-and-fur was slower with the highest levels (2.5 and 3.7% respectively) seen on day 12 post-dosing. After reaching a peak, elimination of radioactivity from the tissues occurred with a half-life of approximately 2-5 days (well perfused tissues such as the liver and kidneys) or approximately 2 weeks (poorly perfused tissues such as white adipose tissue). On completion of the study (88 days) approximately 2% of the administered radioactivity remained in the tissues, primarily in the skin and fur (Elcombe, 2005a).
Overall, chlorinated paraffins and fatty acids methyl esters are expected to show a different bioaccumulation behavior. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Conclusions:
- The study on Medium Chain Chlorinated Paraffins/Alkanes, C14-C17, chloro provides insight about how chlorinated products are metabolized into the body, while study on ethyl oleate covers the behavior of Fatty acids esters.
Overall, chlorinated paraffins and fatty acids methyl esters are expected to show a different bioaccumulation behavior.
Reference
In the gastrointestinal tract and/or livers similar biological processes occurred, enzymatic hydrolysis is the process by which the fatty acids are enzymatically degraded primarily via beta-oxidation. Alternative oxidation pathways (alpha- and omega-oxidation) are available and are relevant for degradation of branched fatty acids. Unsaturated fatty acids require additional isomerization prior to enter the beta-oxidation cycle. The methanol is slowly oxidized in the liver by the enzyme alcohol dehydrogenase (ADH) to formaldehyde, which itself is oxidized very rapidly by the enzyme aldehyde dehydrogenase (ALDH) to formic acid. Finally, formic acid is slowly metabolised to CO2 and H2O.
Data on Medium Chain Chlorinated Paraffins/Alkanes, C14-C17, chloro provide insight about the absorption, tissue distribution and elimination of a14C-labelled C14 -17 chlorinated paraffin (52% chlorinated) after a single oral gavage administration at a dose level of 525 mg/kg bw in male rats.
Radioactivity in blood and plasma, urine and faeces, selected tissues (but not gastrointestinal tract) and residual carcass was determined for up to 89 days post dosing. In animals kept in metabolism cages until termination, the average total recovery of radioactivity from urine, faeces and those tissues and organs sampled was 83.6% of the administered dose. Approximately 70% of the dose was recovered in the faeces and approximately 6% in the urine in the first 4 days after administration. This suggests that only about 30% of the orally administered dose was absorbed by day 4. Radioactivity was still detectable in urine and faeces at the end of the study, suggesting mobilization and excretion from tissue depots. Distribution of radioactivity into the liver and kidney was rapid, with highest levels (1.6 and 0.07% of the dose respectively) seen 24 hours after dosing; whereas distribution into fat and skin-and-fur was slower with the highest levels (2.5 and 3.7% respectively) seen on day 12 post-dosing. After reaching a peak, elimination of radioactivity from the tissues occurred with a half-life of approximately 2-5 days (well perfused tissues such as the liver and kidneys) or approximately 2 weeks (poorly perfused tissues such as white adipose tissue). On completion of the study (88 days) approximately 2% of the administered radioactivity remained in the tissues, primarily in the skin and fur.
Description of key information
Although several data on chlorinated paraffins are provided in this dossier, those data are used to evidence the absence of a significant increased toxicity due to chlorination process. Nevertheless, it should be pointed out that a significantly different bioaccumulation behavior is expected between fatty acids methyl esters and chlorinated paraffins.
Key value for chemical safety assessment
Additional information
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.
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