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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
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 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Yasso.B, 01-09-2013
- Test type:
- standard acute 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:
- - Name of test material (as cited in study report): Dimethyl lsophthalate
- Substance type: solid
- Physical state: flakes
- Analytical purity: 99.85%
- Impurities (identity and concentrations): Meets acceptance criteria of <0.5% Dimethyl Terephthalate and 0 .05% ash
- Purity test date: Vendor certificate
- Lot/batch No.: 99275
- Expiration date of the lot/batch:April 2013
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature and humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Raleigh NC
- Age at study initiation: ca 10 weeks
- Weight at study initiation: 268 - 328 g for males and 223 - 245 g for females.
- Housing: 1 per cage in suspended cages. The room was exclusively reserved for rats in acute tests.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet #5012) was provided daily
- Water (e.g. ad libitum): Water was available ad libitum
- Acclimation period: At least one week.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hr light/ dark cycle
IN-LIFE DATES: From: To: Nov 19th 2012 to Dec 3rd 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- Test article was moistened with 0.50 ml of distilled water to form a pasty consistency
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The area clipped began at the shoulders and extended to the hip bone and half way down the flank of each animal.
- % coverage: Approximately 10% of the body surface
- Type of wrap if used: A porous gauze dressing, then the torso was wrapped with a piece of porous dressing to retain the gauze dressing (semi-occlusive) and porous non-irritating tape encircled the entire trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed by gently washing with distilled water.
- Time after start of exposure: 24 Hours exposure
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a dose level of 2000 mg/kg bw.
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5% distilled water - Duration of exposure:
- 24 Hours
- Doses:
- a dose level of 2000 mg/kg bw
- No. of animals per sex per dose:
- five healthy male and five healthy, non-pregnant and nulliparous female
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: The animals were observed twice on Day 0 postdose and once daily for 14 days for mortality, toxicity and pharmacological effects Body weights were recorded pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed twice on Day 0 postdose and once daily for 14 days for mortality, toxicity and pharmacological effects.
Body weights were recorded pretest, weekly and at termination. Also at study termination all animals were examined for gross pathology.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All ten animals survived the single 2000 mg/kg 24-hour dermal exposure without adverse effect.
- Clinical signs:
- other: Dermal Observations: At 24 hours and Day 14, erythema and edema were absent. Systemic Observations: There were no abnormal physical signs observed. Necropsy Findings: The gross necropsy revealed no observable abnormalities.
- Gross pathology:
- All animals were humanely sacrificed using CO2 following study termination and were examined for gross pathology. No abnormalities were observed.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LDso of Dimethyl Isophthalate is greater than 2000 mg/kg of bw in rats. The substance is not classified for acute dermal toxicity according to Regulation EC Nol. 1272/2008.
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