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EC number: 212-476-9 | CAS number: 821-38-5
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer reviewed, published data, comparable to guideline, non GLP, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- A method using thin-layer chromatography, high performance liquid chromatography, and mass spectrometry was developed for the quantification of C9, C10, C11, and C12 dicarboxylic acids in serum, urine, and feces of human volunteers and rats after oral administration of the acids.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- C9-C12 dicarboxylic acids
- IUPAC Name:
- C9-C12 dicarboxylic acids
- Details on test material:
- C9, C10, C11 , and C12 dicarboxylic acids (99% pure) were purchased from Fluka, A.G.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [ 10,11-³H]dodecandioic acid (sp act 20 mCi/mM, Radiochemical Center, Amersham, England)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Weight: 250-270 g
Age: 7 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Rats in each group were given, in a single dose, a different dicarboxylic acid in powder form by stomach intubation followed by water.
- Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20mg, 50 mg, 100 mg per animal (corresponding to 5; 12.5; 25 mg/kg bw)
- No. of animals per sex per dose / concentration:
- 10 animals per dose.
- Control animals:
- yes
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- Daily serum samples were collected and examined separately for a period of 6 days after administration of the dicarboxylic acids.
Fifty µg of internal standard was added to 1 ml of each serum sample. The internal standard was a dicarboxylic acid with one more C-atom than in the administered acid (e.g., in humans given C9 dicarboxylic acid, the internal standard was the C10 dicarboxylic acid). Sera were acidified to pH 1 with 1 N HCI, saturated
with NaCI, and extracted three times with 10 ml of warm (40°C) ethyl acetate. The combined extracts were dried over anhydrous Na2S04. The extracted solutes
were recovered after evaporation of the solvent under reduced pressure (below 40°C) in a rotatory evaporator.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- About 2% of ³H administered was recovered in feces of rats. The maximum radioactivity was detected between the 3rd and the 4th day. No traces of labeled diacids were found.
- Details on distribution in tissues:
- Tissue lipids.
The radioactivity levels were lower in the lipid extracts of organs (20-40%) than in the residual matter. In the phospholipid and triglyceride fractions, ³H was distributed in the whole molecule and not only in the fatty acid portion. However, radioactivity was detected in all the fatty acids, both saturated and unsaturated. Traces of C12, C10, C8 and C6 dicarboxylic acids were detected in the first 24 hr after administration.
- Details on excretion:
- The aim of these experiments was to determine the fate and distribution of ³H after oral administration of 100 pCi of [10,11-³H]dodecandioic acid.
Urine: In rats about 50% of the ³H were recovered from the urine collected over a period of 5 days.
Sera: As in the urine, labeled dicarboxylic acids were present up to 72 hr, mainly represented by diacid metabolites.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Dicarboxylic acids, mainly represented by diacid metabolites (C10, C8, and C6 when C12 was given), were found in urine up to 72 hr after the oral dose
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Based on the results of this study, saturated medium chain length (C9 to C12) dicarboxylic acids are rapidly and completely absorbed from the gastrointestinal tract and rapidly distributed. These compounds are metabolised to shorter diacids and excretion is low and exclusively via urine. There is no potential for accumulation. Based on a read across (category approach), tetradecanedioic acid does not represent also a potential for bioaccumulation.
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