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Diss Factsheets
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EC number: 603-333-5 | CAS number: 129423-55-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Sept - Oct 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
The acute toxicity potential of Dioctyldodecyl Dodecanedioate was assessed in vitro using XCellR8's Internally Validated Human Cell-Based Screen (Non-Regulatory Method).
- Short description of test conditions:
The test uses cultured human dermal fibroplasts in animal product-free culture, Neutral Red Uptake (NRU) endpoint measurement and a prediction model, based on the GHS classification system for acute toxicity.
After a 24 hour (+/- 1 hour) exposure of 8 concentrations of the test substance in cell culture medium containing 1% DMSO to Human Dermal Fibroblasts (HDFn-XF), cytotoxicity was evaluated.
- Parameters analysed / observed:
IC50 values were >20 ug/ml (max dose tested) in each of the replicates (reps 3,4 and 5) for the test item as the cell viability did not fall below 50%. - GLP compliance:
- yes
- Test type:
- other: In vitro
- Limit test:
- no
Test material
- Reference substance name:
- 1,12-bis(2-octyldodecyl) dodecanedioate
- EC Number:
- 603-333-5
- Cas Number:
- 129423-55-8
- Molecular formula:
- C52 H102 O4
- IUPAC Name:
- 1,12-bis(2-octyldodecyl) dodecanedioate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source : Croda Europe. Supplier batch: P-4697
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Test item was stable, test item formulations prepared using solvent DMSO and used on the day of dosing
Test animals
- Species:
- other: Human Dermal Fibroblasts in Xeno-Free Culture (HDFn-XF)
Administration / exposure
- Route of administration:
- other: The cells were incubated with the test item (concentration 20ug/ml) for 24 +/- 1h in a humidified incubator set at 37C, 5% CO2
- Vehicle:
- other: Cell culture medium with 1% DMSO
- Doses:
- 0.02 mg/mL, 0.01 mg/mL, 0.005 mg/mL, 0.0025 mg/mL, 0.00125 mg/mL, 0.00063 mg/mL, 0.00031 mg/mL, 0.00016 mg/mL
- No. of animals per sex per dose:
- Five main experiments were carried out allowing the determination of the IC50.
- Control animals:
- other: A single application of culture medium was applied as the negative control. A single application of culture medium containing 1% DMSO was applied as the solvent control
- Details on study design:
- Preliminary testing: Determination of the top concentration by solubility testing
Range Finding Experiment: To assess test item cytotoxicity and set a more precise dosing range for the main experiment
Main Experiment: Final classification of the test item. 5 repetitions were performed.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- other: IC50
- Effect level:
- > 20 other: ug/ml
- Based on:
- test mat.
Any other information on results incl. tables
Five main experiments were performed with a top test concentration of 20 ug/ml and a dilution factor of 2. Data from Reps 1 and 2 was not used to obtain the result due to not meeting the required acceptance criteria. All acceptance criteria was met for Reps 3, 4 and 5.
A positive control plate with a top concentration of 100ug/ml and a dilution factor of 1.2 was run in parallel with each test item replicate to validate the assay.
The test item did not cross the 50% viability threshold at any of the concentrations tested and as a result the IC50 was not able to be calculated and therefore is >20ug/ml (0.02 mg/ml).
Due to this, and the solubility limitiations not enabling the concentration of the test item to be increased in the Main Experiment, the maximum dose used in the assay was 20 ug/ml.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- A prediction model was used to convert the IC50 value to a corresponding GHS classification for acute oral toxicity
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