Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 238-925-9 | CAS number: 14858-73-2
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-03-01 to 2007-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- adopted 13. April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Environmental Health and Safety Publications, Series on Testing and Assessment No. 28, Guidance Document for the Conduct of Skin Absorption Studies; Environment Directorate, Organisation for Economic Co-operation and Development; March 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance for Ind.; Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documen.; U.S. Dep. Health a. Hum. Serv., Food a. Drug Admin., May 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2-ethylhexyl) carbonate
- EC Number:
- 238-925-9
- EC Name:
- Bis(2-ethylhexyl) carbonate
- Cas Number:
- 14858-73-2
- Molecular formula:
- C17H34O3
- IUPAC Name:
- bis(2-ethylhexyl) carbonate
- Test material form:
- other: liquid
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Skin membranes from female human abdominal origin from cosmetic surgery
- Details on test animals or test system and environmental conditions:
- IN VITRO TEST
Skin membranes from female human abdominal origin from cosmetic surgery were used. Split skin (approx. 500 µm) was prepared with a dermatome and comprises the stratum corneum, the epidermis and part of the dermis. With a punch (10 mm diameter) skin slices were produced for the use in the diffusion cell. The skin pieces were frozen between microscopical slides at = -15°C. Thickness of the prepared splitted skin was measured between the two microscopic slide mounts.
Administration / exposure
- Vehicle:
- other: Receptor fluid DMEM with 10 % FCS
- Duration of exposure:
- 24 hours
- Doses:
- - Dose volume: 40.0 µL test substance (approx. 99.9%)
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: human female, abdominal origin from cosmetic surgery
- Ethical approval if human skin: no data
- Type of skin: stratum corneum, the epidermis and part of the dermis
- Preparative technique: Split skin (approx. 500 µm) was prepared with a dermatome
- Membrane integrity check: yes
- Storage conditions: = -15 °C
Results and discussion
- Absorption in different matrices:
- - Receptor fluid, receptor chamber, donor chamber (in vitro test system): No Bis(2-ethylhexyl) carbonate could be detected in the skin penetration samples up to a skin exposition time of 24 h.
- Skin preparation (in vitro test system): no data
- Stratum corneum (in vitro test system): (i.e tape strips) no data
Percutaneous absorption
- Dose:
- 40.0 µL
- Parameter:
- percentage
- Absorption:
- 0 %
- Remarks on result:
- other: 24 hours
- Remarks:
- No bis(2-ethylhexyl) carbonate could be detected in the skin penetration samples up to a skin exposition time of 24h.
Any other information on results incl. tables
The results of the in-study validation data show that the used method is able to quantify Bis(2-ethylhexyl) carbonate in cell culture medium with the respective precision and accuracy down to a concentration of 10.0 µg/mL for Bis(2-ethylhexyl) carbonate.
In all 60 samples the concentrations of Bis(2-ethylhexyl) carbonate was < 10.0 µg/mL. 6 skin samples were used and 10 medium samples were collected during a 24 -hour period each.
In conclusion it can be stated that no Bis(2-ethylhexyl) carbonate could be detected in the skin penetration samples up to a skin exposition time of 24 h.
Applicant's summary and conclusion
- Conclusions:
- No Bis(2-ethylhexyl) carbonate could be detected in the skin penetration samples up to a skin exposure time of 24 h. Therefore, Bis(2-ethylhexyl) carbonate is not expected to penetrate the human skin.
- Executive summary:
The percutaneous absorption of Bis(2-ethylhexyl) carbonate (99.9 % a.i.) was assayed by using an in vitro method according to OECD Guideline 428, adopted 13. April. 2004. The penetration profile of the test item in human abdominal skin was analysed using an in vitro flow-through diffusion cell. A validated GC-MSD method was used to measure Bis(2-ethylhexyl) carbonate in cell culture medium (DMEM with 10% FCS). The results of the in-study validation data show that the used method is able to quantify Bis(2-ethylhexyl) carbonate in cell culture medium with the respective precision and accuracy down to a concentration of 10.0 µg/mL for Bis(2 -ethylhexyl) carbonate, corresponding to a detection limit of 0.025%. No Bis(2-ethylhexyl) carbonate could be detected in the skin penetration samples up to a skin exposure time of 24 h. Therefore, Bis(2-ethylhexyl) carbonate is not expected to penetrate the human skin.
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.