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Diss Factsheets
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EC number: 907-870-9 | 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
There are no data available for the diisobutyl esters, therefore this endpoint is assessed using read across to data available on the methyl esters and also the hydroysis products, isobutanol, and the constituent acids (adipic, succinic, glutaric).
Three genotoxicity studies are available. Dibasic ester blend was tested in vitro in a bacterial reverse mutation assay, similar to an Ames test but using 3 strains of Salmonella typhimurium, and showed no mutagenic activity in this test system with or without S9 metabolic activation system (from liver or olfactory origin) up to the highest concentrations tested.
Dibasic ester blend was also tested in vitro in a chromosomal aberration assay in human lymphocytes. In the presence of liver S9 metabolic activation, a statistically significantly increased proportion of abnormal cells or cells with one or more aberration were observed at 0.3 and 0.4% (equivalent to 3.3 and 4.4 mg/mL, respectively), illustrating a clastogenic activity of the test substance under at high concentrations in the presence of S9. This result is not conistent with what is known about the hydrolysis products of the methyl esters. Methanol is not clastogenic or genotoxic. Adipic acid, glutaric acid and succinic acid are all endogenous and not considered to be clastogenic or genotoxic. As such it is possible that in the presence of S9, the esters were hydrolysed and the acids released affected the pH, making it more acidic. This is known to cause false positive effects in cytogenicity assays.
In accordance with the REACH regulation, an in vivo genotoxicity assay on somatic cells was performed. A bone marrow micronucleus assay was performed in mice following a single inhalatory nose-only exposure to dibasic ester blend for 6 hours. There was no statistically significant differences in the proportion of micronucleated polychromatic erythrocytes between mice of all groups including controls at any sampling time up to 72 hours following exposure up to a very bigh concentration of 19 mg/L (equivalent to19000mg/m3), illustrating the absence of clastogenicity of the test substance in vivo.
No data are available for the mammalian cell mutagenicity. However Isobutanol is not genotoxic to bacteria or mammalian cells, and the acids are endogenous in mammals and therefore highly unlikely to be be genotoxic at relevant exposure levels to humans.
In addition, in a 90 day study there was no evidence of pre-neoplastic lesions at the highest doses that could be tested. Therefore it is concluded that there is sufficient data available to conclude that this substance is not mutagenic or clastogenic to mammalian cells.
Short description of key information:
Clastogenic in vitro in a chromosomal aberration test on human lymphocytes but negative in an in vitro bacterial reverse mutation assay and an in vivo mouse bone marrow micronucleus assay.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Overall, based on the available read across information the genetic toxicity of dibasic ester blend is considered to be negative and therefore no classification is warranted according to the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
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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