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Diss Factsheets
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EC number: 915-680-2 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Assessment of toxico-kinetics from relevant available information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 421-like
- Principles of method if other than guideline:
- Percutaneous Penetration with Mucaca Mulata (Monkeys)
- GLP compliance:
- not specified
- Remarks:
- Not applicable ( prior to 1981)
Test animals
- Species:
- monkey
- Strain:
- Mulatta arctoides
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Excretion: Three rhesus monkeys received the radioactive material (1mg/kg) via an intramuscular injection into the lower legs. The intramuscular administration was selected based on the experience of the lab and the known difficulties in Intra venous administration with rhesus monkeys
absorption: pregnant female rabbits
Administration / exposure
- Route of administration:
- not specified
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- ( hours): 0-4,4-8,8-12,12-24,24-48,48-72,72-96,96-120,120-144,144-168,168,192 and 192-216
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 3 000 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- Three Mucaca mulata were used for each approach
- Details on study design:
- The percutaneous study consists of a two-step process:
- Step 1 :Excretion kinetics of a substance are determined following a parental injection of the radiolabeled substance
- Step 2: The substance then is applied topically and the amount excreted is corrected for the previously determined parenteral excretion kinetics.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Absorption through the abdominal wall was very slow with only 0.856% of the dose recovered in the first 24 hours after application. This can be compared to the 63.84% recovered after the intra muscular route of administration. Total urinary recovery for this study was 7.91± 0.61% and using the correction factor determined from the 76.21% parenteral dose, which was 1.311, the actual penetration of radiolabeled substance would be 10.37±0.8%. The excretion rates showed prolonged but low level excretion of the radioactivity. Unlike the parenteral dose, the maximum excretion rate occurred during the 24-48hours collection period.
- Details on distribution in tissues:
- not mentioned
- Details on excretion:
- Step 1
Three rhesus monkeys received the radioactive material (1mg/kg) via an intramuscular injection into the lower legs. The intramuscular administration was selected based on the experience of the lab and the known difficulties in Intra venous administration with rhesus monkeys. Elimination via the kidney appears very rapid for the radiolabeled substance with 38.15% recovered in the urine in the first 4 hours and 63.854% total in the first 24 hours. After 48 hours only 5.92 was recovered the next 168 hours. Total urinary was 76.21± 7.94% of the parenteral dose. Plotted against time, the data are consistent with a two compartment open model. The most rapid elimination phase ( α) provides a half time of elimination k=4.5 h-1 while the secondary elimination phase (β) provides k= 11.0 h-1.
Step 2
Three Mucaca mulata were used for each approach. The first one involved rhesus monkeys with unwashed polyester fabrics containing 5.91% of radiolabeled substance and the second with scoured polyester fabric containing 2.5% radioactive chemical. Each patch was applied on the stomach of each monkey, wetted with human urine and left next to the skin for a 24-hour exposure period. These patches were not to be occluded in anyway. Urine samples were collected for a total period of 216 hours, and for a similar period for the feces. The purpose of this study was to determine the amount of radiolabeled substance that can be extracted from threated polyester fabric (unscoured and scoured) with human urine and then absorbed via percutaneous route on rhesus monkey. The radiolabeled substance had a specific activity of 1.84 mCi/mg. The exact radioactive load per 4” x5” patch was determined from a randomly selected patch prepared in a similar manner.
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- not mentioned
Applicant's summary and conclusion
- Conclusions:
- The excretion rates showed prolonged but low level excretion of the radioactivity
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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