Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-176-9 | CAS number: 6422-86-2
- 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
Bioaccumulation: aquatic / sediment
Administrative data
- Endpoint:
- bioaccumulation in aquatic species: invertebrate
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-12-17 to 1986-01-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 850.1710 (Oyster Bioconcentration Test)
- Deviations:
- yes
- Remarks:
- The study report documented minor deviations from the study protocol. The noted deviations were not believed to affect the results of the study.
- GLP compliance:
- yes
- Remarks:
- Deviations did not impact the outcome of the test.
Test material
- Reference substance name:
- bis (2-ethylhexyl) terephthalate
- IUPAC Name:
- bis (2-ethylhexyl) terephthalate
- Reference substance name:
- Bis(2-ethylhexyl) terephthalate
- EC Number:
- 229-176-9
- EC Name:
- Bis(2-ethylhexyl) terephthalate
- Cas Number:
- 6422-86-2
- Molecular formula:
- C24H38O4
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester
- Reference substance name:
- Di (2-ethylhexyl) terephthalate, DEHT; Dioctyl terephthalate, DOTP
- IUPAC Name:
- Di (2-ethylhexyl) terephthalate, DEHT; Dioctyl terephthalate, DOTP
- Details on test material:
- The test material was supplied to the testing facility in 2 forms; bis (ethylhexyl) terephthalate and bis (2-ethylhexyl) (hexyl-2-14C)
Bis (2-ethylhexyl) terephthalate:
Purity of the sample: 100 %
Storage conditions of test material: room temperature
Lot/Batch No.: 84-6-20
Physical appearance: clear viscous liquid
Bis (2-ethylhexyl) terephthalate (hexyl-2-14C):
Purity of sample: >98.5%
Storage conditions of test material: refrigerated in radioactive materials section of the testing facility
Lot/Batch No.: 1249-297
Physical appearance: clear liquid dissolved in methanol
Both materials were used to prepare the primary stock and dosing material for the test.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Radiolabelling:
- yes
Sampling and analysis
- Details on sampling:
- Duplicate 1-mL water samples were taken from the middle of the exposure and solvent control aquaria on Days 1, 3, 6, 10, 14, 17, 21, and 24 of the bioconcentration phase, and on Days 1, 3 , 7, 11, and 14 of the depuration phase.
Test organisms
- Test organisms (species):
- other aquatic mollusc: Crassotrea virginica
- Details on test organisms:
- TEST ORGANISM
Common name: Eastern Oyster
Supplier: Aquatic Research Corporation, East Dennis, MA
Age at study initiation: prespawning condition
Length at study initiation: 3.5 - 5.6 cm
Health: free of disease through histological examination
ACCLIMATION/TEST CONDITIONS
Acclimation Period: All oysters were held in unfiltered Duxbury Bay seawater for 12 d prior to testing. At that time, thery were moved to a tray receiving test dilution water, which was coarsely (30 µm) filtered Duxbury Bay seawater.
Photoperiod: 14 h daylight/10 h darkness with a 30-min phase-in period
Feeding: Saltwater alga, Isochrysis galbana, used as a food supplement
Culture Water: Coarsely filtered (30 µm) Duxbury Bay seawater
Study design
- Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: marine
- Total exposure / uptake duration:
- 24 d
- Total depuration duration:
- 14 d
Test conditions
- Test temperature:
- 19.4 - 22.7 °C
- pH:
- 7.86 - 8.07
- Dissolved oxygen:
- 6.8 - 8.9 mg/L
- Salinity:
- 32.5-34.0 ‰
- Details on test conditions:
- One hundred twenty (120) individual oysters were cleaned and measured prior to test initiation. Sixty (60) organisms were randomly placed in each container. Two glass 20-gallon aquaria were used in the test. Each aquarium was fitted with a stand-pipe drainage system to maintain a water depth of 15 cm and test solution volume of approximately 40 L. During the exposure period, one aquarium received 50 µg of 14C-DOTP /L salt water and the other aquarium (solvent control) received a combination of solvent and salt water. Both aquaria received dilution water at a continuous flow rate of 60 L/h.
The 14C-DOTP was dissolved in distilled-in-glass acetone and metered to the test aquarium at a rate of 0.057 mL/L salt water using a peristaltic pump. Similarly, 838 mL of acetone was combined with 162 mL of deionized water and metered to the solvent control at a rate of 0.068 mL/L salt water. The 14C-DOTP was allowed to equilibrate with the physical system for a 3-d period prior to test initiation. After equilibration, duplicate 1-mL water samples were taken to verify that the exposure concentration was within 30% of nominal. Exposure of the oysters to 14C-DOTP at a nominal concentration of 50 µg/L was continuous for 24 d. After 24 d of exposure, all remaining oysters from the test aquaria were transferred to clean aquaria in which toxicant-free salt water was introduced at a rate equal to the flow rate during exposure. The depuration period continued for 14 d to estimate half-life. - Nominal and measured concentrations:
- Nominal concentration: 50 µg/L 14C-DOTP
Measured concentration: 48.4 ± 7.56 µg/L (97% of nominal)
Results and discussion
Bioaccumulation factor
- Type:
- BCF
- Value:
- 393
- Basis:
- whole body w.w.
- Remarks:
- at equilibrium
- Time of plateau:
- 14 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Statistical analysis (ANOVA) performed on the results of tissue analyses from Days 14, 17, and 21 suggested equilibrium had been attained.
Depuration
- Elimination:
- yes
- Parameter:
- DT50
- Depuration time (DT):
- 5 d
- Metabolites:
- 72.9 to 75.5% of the residues remaining in the tissues after 14 d of depuration was parent compound and the remaining 24.5 to 27.1% were metabolites and/or degradation products.
- Details on results:
- The concentration of 14C-residues measured in the homogenized oyster tissues increased substantially during the first 3 d of exposure. This was the period of maximum accumulation of 14C-residues. The mean measured concentration of 14C-DOTP on Day 3 of exposure represented a maximum BCF of 790X. Between days 3 and 10, the 14C-residue concentration in tissues decreased substantially (50%). At Day 10 and throughout the remaining 14 days of exposure, an apparent equilibrium between the rates of accumulation and elimination of 14C-residues in oyster tissues existed. The mean BCF at equilibration was 393X.
Any other information on results incl. tables
Bioconcentration of 14C-DOTP Residues in Soft Tissues of Oysters during 24 Days Exposure to 50 µg/L DOTP | ||||
Concentration of 14-C Residues | ||||
Exposure Period Day | Salt Water (µg/L) | Cumulative Mean Salt Water (µg/L) | Oyster Tissue (µg/kg) | BCF* |
0 | 45.9 | |||
1 | 46.6 | 46.2 | 5720 | 124 |
3 | 44.8 | 45.8 | 36200 | 790 |
6 | 44.8 | 45.6 | 27200 | 596 |
10 | 52.4 | 46.9 | 18400 | 392 |
14 | 34.6 | 44.9 | 22200 | 494 |
17 | 52.0 | 45.9 | 21000 | 458 |
21 | 57.5 | 47.3 | 17600 | 372 |
24 | 56.5 | 48.4 | 15600 | 322 |
Notes: | ||||
Cumulative mean concentration is based on progressive data (days 0-24) | ||||
*Bioconcentration Factor (BCF) is the mean measured 14C-residues of DOTP in tissues divided by the cumulative mean measured concentration in exposure water |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The BCF of 14-C DOTP in oyster tissues at equilibrium was 393X. Half-life of the accumulated 14C-residues in oyster tissues was between days 3 and 7 of the depuration period. Most of the 14C-residues remaining in the tissues after 14 days of depuration were the parent material. There were metabolites and/or degradation products present in the soft tissues.
- Executive summary:
A 38-d study was performed to investigate the bioconcentration and elimination of 14C-DOTP in the soft tissues of eastern oysters, Crassostrea virginica, continuously exposed to 14C-DOTP at a nominal concentration of 50 µg/L. The maximum bioconcentration factor for 14C-DOTP in oyster tissue was 790X and was observed on Day 3 of the exposure period. Apparent equilibrium was established between days 10 and 24. The BCF at equilibrium was 393X. Half-life of the accumulated 14C-residue content present in oyster tissues occurred between days 3 and 7 of the depuration period. Most of the 14C-residues (72.9 to 75.5%) remaining in the tissues of oysters after 14 days of depuration were the parent DOTP. The remaining 24.5 to 27.1% were metabolites and/or degradation products.
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.