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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11/13/2012 to 02/28/2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl isophthalate
- EC Number:
- 215-951-9
- EC Name:
- Dimethyl isophthalate
- Cas Number:
- 1459-93-4
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 1,3-dimethyl benzene-1,3-dicarboxylate
- Test material form:
- solid: flakes
- Details on test material:
- Opaque white solid
- Name of test material (as cited in study report): Dimethyl Isophthalate, CAS# 1459-93-4,
- Physical state: Solid
- Analytical purity: 99.85%
- Impurities (identity and concentrations): Dimethyl Terephthalate, <0.5% (Maximum) (accepted level)
- Purity test date: 10-23-2012
- Lot/batch No.: Batch# 99275
- Expiration date of the lot/batch: 04/2014
- Storage condition of test material: Room Temperature and humidity
- Other: Melting point 67-68 degC
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Raleigh NC and SAGE Labs, Boyertown, PA,
- Age at study initiation: 3 weeks
- Weight at study initiation: 182 - 223 grams
- Housing: The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing
- Diet (e.g. ad libitum): Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing
- Water (e.g. ad libitum): Ad libidum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled but not reported the actual temperature
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): a 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% in methyl cellulose
- Lot/batch no. (if required): Methyl Cellulose, Lot# AD-11326-58 and Tween 80®, Lot# A0313394
DOSAGE PREPARATION (if unusual):
Test article was ground with mortar and pestle and electronic grinder. The test material was mixed with 2% Methylcellulose to make a 20% white slurry mixture.
Vehicle preperation:
2.0 g Methylcellulose powder was added to 100 ml of warm distilled water
while on stir plate; two drops of Tween® 80 were added to the mixture; the mixture remained on a stir plate until solution began to gel and was then placed in the refrigerator overnight. The vehicle was prepared for each dose. (2% Methylcellulose solution) (Clear colorless liquid)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: comply with the standards set forth in OECD Guidelines for the Testing of Chemicals - Doses:
- 2000 mg/kg of BW
The test article was mixed with 2% methylcellulose to make dosing by gavage possible. The dose was based on the dry weight of the test article. Initially, a single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to three female rats. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg. - No. of animals per sex per dose:
- Initially three healthy female Sprague Dawley rats were dosed orally with Dimethyl Isophthalate, at 2000 mg/kg. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days.
Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, toxicity and pharmacological effects, and twice daily for mortality. All animals were examined for gross pathology.
Results and discussion
- Preliminary study:
- Initially, a single dose was administered orally by gavage at a dose level of 2000 mg/kg to three female rats
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0 of 6 female rats. All six females survived the single 2000 mg/kg oral dose
- Clinical signs:
- other: There were no abnormal physical signs observed.
- Gross pathology:
- The gross necropsy of all animals revealed no observable abnormalities in five out of six animals; hematomas were observed on the ovaries of one animal.
- Other findings:
- The gross necropsy of all animals revealed no observable abnormalities in five out of six animals; hematomas were observed on the ovaries of one animal.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dimethyl Isophthalate was tested in an OECD 423 guideline study of acute oral toxicity by gavage. The oral LD50 is greater than 2000 mg/kg body weight in female rats. The conclusion is that the substance is not classified for acute oral toxicity according to Regulation EC No. 1272/2008.
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