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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-882-9 | 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
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read across study
- Justification for type of information:
- Based on its composition and physico chemical properties, fatty acids, C5-9, hexaesters with dipentaerythritol is considered to be a suitable read across substance to address the skin irritation endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- not specified
- Test system:
- human skin model
- Remarks:
- Reconstructed Human Epidermis (RHE)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- test material used as received, undiluted
- Duration of treatment / exposure:
- 1, 4, and 24 h
- Number of replicates:
- each treatment was conducted in duplicate
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- ET50 (hr) > 24
- Value:
- 88.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions.
- Executive summary:
A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 439. MatTek EpiDerm tissue samples were exposed to undiluted substance for 1, 4 or 24 h. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 450 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiDerm tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions (DeGeorge, 2002).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 7, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Based on its composition and physico chemical properties, fatty acids, C5-9, hexaesters with dipentaerythritol is considered to be a suitable read across substance to address the eye irritation endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- MatTek EpiOcular MTT Viability Assay.
Draize correlation - Deviations:
- no
- GLP compliance:
- not specified
- Species:
- other: MatTek EpiOcular tissues
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 100 µl test material used as received undiluted
- Duration of treatment / exposure:
- 4, 16, 64, and 256 min
- Number of animals or in vitro replicates:
- Each treatment was conducted in duplicate
- Irritation parameter:
- other: Viability assay %
- Run / experiment:
- 256 min
- Value:
- 66.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions.
- Executive summary:
A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 492. MatTek EpiOcular tissue samples were exposed to undiluted substance for 16, 64 or 256 min. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 540 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiOcular tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions (DeGeorge, 2002).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 439. MatTek EpiDerm tissue samples were exposed to undiluted substance for 1, 4 or 24 h. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 450 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiDerm tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions (DeGeorge, 2002).
Eye irritation
A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 492. MatTek EpiOcular tissue samples were exposed to undiluted substance for 16, 64 or 256 min. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 540 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiOcular tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions (DeGeorge, 2002).
Justification for classification or non-classification
Based on the results of in vitro studies with the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, the test substance does not require classification for skin or eye irritation according to EU CLP (EC 1272/2008) criteria.
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.