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Diss Factsheets
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EC number: 271-079-9 | CAS number: 68515-38-8 A complex combination of hydrocarbons produced by the esterification of phthalic anhydride with isodecyl alcohol. It consists predominantly of C10 primary aliphatic alcohols, C9-10 paraffins, saturated and unsaturated C20 ethers and boiling in the range of approximately 120°C to 230°C (248°F to 446°F).
- 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
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Endpoint summary
Administrative data
Description of key information
Skin Irritation – Category 3 Mild Skin Irritant based on WOE approach
In vitro testing data (OECD 439) indicated that 1,2-Benzenedicarboxylic acid, isodecyl ester, manuf. of, by-products from (C10/11 Discard Alcohol) is an irritant. However, the in vitro skin corrosion test (OECD 431) was negative for corrosion and the in vivo murine Local Lymph Node Assay skin sensitisation data (OECD 429) for structural analogues 1,2-Benzenedicarboyxylic acid, isononyl ester, manuf. of, by-products from (C9 Discard Alcohol) and 1,2-Benzenedicarboyxylic acid, trideyl ester, manuf. of, by-products from (C13 Discard Alcohol) indicate that the substances were not skin sensitiserstisers (i.e., mean SI score of ≥1.5 and < 2.3 for erythema/eschar). In addition, the oral acute toxicity test did not indicate toxicity up to the limit dose level >2000 mg/kg/day. Taken together, a classification of Category 3 Mild Skin Irritant is warranted based on EU GHS classification.
Eye Irritation – Category 2 Eye Irritant based on WOE approach
Due to inconclusive results for eye irritation in 2 endpoint studies (OECD 437 and 492) for the submission substance, QSAR modeling was performed to enhance confidence in classifying these substances as irritants or non-irritants. The QSAR analysis was performed using National Institute for Public Health and Environment (RIVM) BfR eye irritation/corrosion v.1.0 model, and the submission substance was predicted to be an eye irritant. The submission substance testing data indicated minimal irritation, but not sufficient for classification as Category 1. Based on the weight of evidence (WOE) these data suggest that the submission substance should be classified as a Category 2 eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for read across for skin irritation:The testing data for the submission substance indicated that the in vitro data was a false positive for a skin irritant. This was based on the in vivo LLNA data for C9 and C13 Discard Alcohol that showed that these were mild irritants. Discard Alcohols are a homologous series of UVCB substances produced by the same manufacturing process, differing primarily in the carbon number distribution of the constituents. The read-across hypothesis is based on structurally similar constituent pools and assumption of a similar mode of action based on constituent pools exchanging with cell membranes, resulting in cytotoxicity at high concentrations unless eliminated.
Justification for classification or non-classification
Skin Irritation – Category 3 mild skin irritant according to GHS classification. "No Classification" according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Eye Irritation – Category 2 eye irritant according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
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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