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EC number: 215-951-9 | CAS number: 1459-93-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 13-week repeated dose toxicity study conducted by the US National Cancer Institute. Precedes establishment of GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- Remarks:
- precedes establishment of GLP
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyl terephthalate
- EC Number:
- 204-411-8
- EC Name:
- Dimethyl terephthalate
- Cas Number:
- 120-61-6
- Molecular formula:
- C10H10O4
- IUPAC Name:
- dimethyl terephthalate
- Test material form:
- solid: crystalline
- Details on test material:
- obtained from Eastman Chemical Products Inc., Kingsport, TN, USA. Lot C4B (crystalline powder) or Lot EC No. 2/27/76 as briquette ground to a fine powder before use, 99.99-100% pure. (Impurity not identified).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Center, Frederick, MD, USA.
- Age at study initiation: 7 weeks
- Weight at study initiation: 87.6 +/- 3.2 g (males), 70.0 +/- 2.9 g (females)
- Housing: Polycarbonate, with Betta-chip bedding (Northeastern Products Corpl, Warrensburg, NY, USA
- Diet (e.g. ad libitum): ad libitum, Wayne Lab Biox, Allied Mills, Inc. Chicago, IL
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-55%
- Air changes (per hr): 12 times per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): basal diet, Wayne Lab-Blox meal (Allied Mills, Inc. Chicago, IL, USA) using Patterson-Kelly twin-shell blender fitted with an intensifier bar.
- Storage temperature of food: room temperature
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil, as dust suppressant
- Concentration in vehicle: 2% of initial weight
- Lot/batch no. (if required): source: Duke's Corn Oil, C.F. Sauer Co., Richmond, VA, USA
Control animals received the basal diet containing 2% corn oil. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration of test material was determined for randomly selected batches of formulated diet. The mean analytical concentration for the checked samples was within 4.3% of the theoretical concentration, with a coefficient of variation of 5.7%.
Duplicate 4 g samples of diets were agitated with 10 ml of benzene and supernatant was analyzed by gas chromatography using a flame ionization detector. Spiked samples and a feed blank were included. All tests were conducted at Hasleton Laboratories. - Duration of treatment / exposure:
- 13 week dose-range finding study for 103 week lifetime bioassay
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1750 to 20000 ppm
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- Dose selection rationale: based on 14-day toxicity study results.
Doses in the 13-week study were (ppm): 1750, 2500, 5000, 10000, 20000.
Examinations
- Observations and examinations performed and frequency:
- Animals were observed twice daily. Clinical signs and the presence of palpable masses were recorded every week. Mean body weights and food consumption were recorded every week.
- Sacrifice and pathology:
- Animals were sacrificed by exsanguination under sodium pentobarbital anesthesia (Diabutal, Diamond Laboratories Inc., Des Moines, Iowa) and necropsied. The pathologic evaluation consisted of gross and microscopic examination of major tissues, major organs, and all gross lesions. The tissues were presevered in 10% buffered formalin, embedded in paraffin, sectioned and stained with hematoxylin and eosin. The following tissues were examined microscopically: brain, pituitary, spinal cord, eyes, esophagus, trachea, salivary gland, mandibular lymph node, thyroid, parathyroid, heart, thymus, lungs and mainstem bronchi, liver, pancreas, spleen, kidney, adrenal, stomach, small intestine, colon, urinary bladder, prostate or uterus, testes or ovaries, sternebrae, femur and mammary gland, and any tissue masses.
Necropsies were also performed on all animals found dead.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no deaths
- Mortality:
- no mortality observed
- Description (incidence):
- no deaths
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decreased in males and females at the two highest doses
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- diffuse hepatocellular swelling, not dose-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- All rats survived until the end of the study. Decreases in body weight gain occurred in males and females fed 10000 and 20000 ppm. No gross lesions were observed in rats at necropsy. Microscopic examinations of livers of treated rats showed diffuse hepatocellular swelling which was not dose-related.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 5000 ppm is approximately 200 mg/kg bw/day, assuming food consumption of 20 g/day and body weight of 0.5 kg/rat.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The NOAEL, 5000 ppm, is approximately 200 mg/kg bw/day, assuming food consumption of 20 g/day and body weight of 0.5 kg/rat (ECHA, 2010, Guidance on information requirements and chemical safety assessment, Chapter R.8 -17, after Gold, et.al, 1984 and Paulussen, et al., 1998)
Applicant's summary and conclusion
- Conclusions:
- Dimethyl terephthalate, a structural analogue of dimethyl isophthalate, was administered to rats in the diet for 13 weeks in a study similar to OECD 408. Doses ranged from 1750 to 20000 ppm. There were no adverse effects on food consumption, clinical signs, gross pathology or histopathology. The NOAEL is 5000 ppm, equivalent to approximately 200 mg/kg body weight/day. Data can be read-across to dimethyl isophthalate from DMTP, based on common functional groups. The substances are isomers. The similarities in structure are likely to apply to metabolites as well, with DMIP breaking down to isophthalic acid, just as DMTP is known to break down to terephthalic acid; these are isomers. Similar structures and similar break-down products for the two substances is the basis for the reading-across of data for this endpoint. This is adequate to fulfill the information requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment.
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