Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 214-277-2 | CAS number: 1119-40-0
- 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 sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitization potential of of a structurally similar sbustance, dibasic esters, was assessed in two in vivo assays. A mouse Local Lymph Node Assay (LLNA), of reliability 1 according to Klimisch cotation criteria, was selected as a key study based on its high reliability and as it is the reference method endorsed by REACH. Several concentration of dibasic esters blend were tested up to 100%, and no increase in the stimulation indices occurred, illustrating the absence of skin sensitization. This is confirmed by a Guinea-Pig Maximisation Test (GPMT), of reliability 2 according to Klimisch cotation criteria and therefore selected as a supporting study, where the concentrations of 10% and 100% were tested. No cutaneous reactions were observed following challenge, corroborating the absence of skin sensitization potential.
Migrated from Short description of key information:
No indication of skin sensitization potential in a Local Lymph Node Assay and a Guinea Pig Maximisation Test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The respiratory sensitization potential of dibasic esters was not formally assessed in a dedicated study, but there was no indication of specific immunotoxicity in rats exposed by inhalation for up to 90 days (see "7.5. Repeated dose toxicity" section for details).
Therefore dibasic ester blend is not considered to be a respiratory sensitizer.
Migrated from Short description of key information:
Not formally assessed but no indication of specific immunotoxicity in 90-day inhalation toxicity studies in rats.
Justification for classification or non-classification
Based on the classification criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP), and given the absence of positive reactions in a LLNA and a GPMT, or signs of specific immunotoxicity in a rat 90 -day toxicity study by inhalation, dibasic ester blend is not classified as a skin or respiratory sensitizer.
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.