Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 446-640-8 | 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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- yes
Test material
- Test material form:
- other: L060 was tested as a radioactive powder and aqueous dilution (500g L060/L).
- Details on test material:
- L060 was tested as a radioactive powder and aqueous dilution (500g L060/L).
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- L060 was tested as a radioactive powder and aqueous dilution (500g L060/L).
Administration / exposure
- Type of coverage:
- other: Production is performed on fresh skin obtained from cosmetic surgery
- Vehicle:
- water
- Duration of exposure:
- exposure (approx.1.5 h) at room temperature.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- The mean percentage potentially absorbable was 0.31 ± 0.42% for the
powder formulation and 0.26 ± 0.33% for the aqueous dilution. - Total recovery:
- The mean recovery of radioactivity was 97 ± 2%
Any other information on results incl. tables
See study report
Applicant's summary and conclusion
- Conclusions:
- The mean in vitro dermal absorption was low in terms of percentage with values of 0.31 ± 0.42% for the powder formulation and 0.26 ± 0.33% for the aqueous dilution.
- Executive summary:
In this study the dermal absorption of [14C]-L060 was investigated using human skin in vitro. L060 was tested as radioactive powder and aqueous dilution (500 g L060/L). One group of 12 human skin discs (7 different donors) was exposed to the L060 powder test formulation mixed with [14C]-L060 for 8 hours under non-occlusion conditions. A second group of 10 human skin discs (6 different donors) was exposed to the L060 aqueous dilution mixed with [14C]-L060 (corresponding to 500 g L060/L) for 8 hours under non-occlusion conditions. The mean recovery of radioactivity was 97 ± 2% for the skin discs exposed to the powder formulation and 96 ± 2% for the skin discs exposed to the aqueous dilution (500 g L060/L). The mean in vitro dermal absorption was low in terms of percentage with values of 0.31 ± 0.42% for the powder formulation and 0.26 ± 0.33% for the aqueous dilution. The in vitro maximum flux of L060 through human skin was 1.14 ± 2.42 μg/cm2/h for the powder formulation and 0.73 ± 0.94 μg/cm2/h for the aqueous dilution.
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.
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