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Registration Dossier
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EC number: 271-085-1 | CAS number: 68515-43-5
- 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
Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day
When corrected for differences in molecular weight between the read-across substance and the registed substance this results in an oral: NOAEL - Males - 87.9 mg/kg/day; Females - 335.5 mg/kg/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 79.6 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A 90 -day sub-chronic oral toxicity has been undertaken on a structurally related substance, phthalic acid di-n-octyl, n-decyl ester (DODP) which has C-chain lengths of C6, C10 compared to di-undecyl phthalate's C11. The No Observed Adverse Effect level (NOAEL) for males is considered to be a concentration of 0.1 % in the diet, corresponding to a mean intake of 79.6 mg/kg bw/day based on hepatotoxic effects shown as histological changes in the liver and effects on liver enzymes. For females the NOAEL is considered to be 0.3 %, corresponding to a mean intake of 303.9 mg/kg bw/day on the basis of increased liver and kidney weights, effects on liver enzymes and haematological parameters.
A two-generation fertility study undertaken on the substance itself,1,2 benzene dicarboxylic acid , di C9 -C11 alkyl esters, resulted in, for parental animals, reduced bodyweight gain amongst males and lower food intake at 10000 ppm, corresponding to a mean daily intake of at least 650 mg/kg/day. At termination, males showed macroscopic liver changes, although relative liver weight was unaffected, and histopathological evidence of hepatocyte necrosis and increased rates of cell turnover. There was no evidence of histopathological effects of treatment upon other organs although a lower adrenal, thymus and spleen weight was evident for high dosage females. A dietary concentration of 5000ppm was regarded as the NOAEL, this corresponding to a dose level of at least 300 mg/kg/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
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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