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EC number: 255-180-5 | CAS number: 41026-17-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- 1,2,3,6-Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropane-1,3-diol
- EC Number:
- 500-091-1
- EC Name:
- 1,2,3,6-Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropane-1,3-diol
- Cas Number:
- 36621-20-2
- Molecular formula:
- (C8H8O3.C5H12O2)x
- IUPAC Name:
- 1,2,3,6-Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropane-1,3-diol
- Reference substance name:
- 1,3-Isobenzofurandione, 3a,4,7,7a-tetrahydro-, polymer with 2,2-dimethyl-1,3-propanediol
- IUPAC Name:
- 1,3-Isobenzofurandione, 3a,4,7,7a-tetrahydro-, polymer with 2,2-dimethyl-1,3-propanediol
- Details on test material:
- As per IUCLID Sections 1.1. 1.2. and 4.1.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female rats were acquired from Texas Animal Specialties; Humble, TX and were Day-i Wt/Day 0 (fasted) Wt: 180-205 gm / 162-187 gm. The animals were housed one/cage in suspended stainless steel with wire bottom. The Actual Temp/Relative Humidity during the study was 19-22°C /30-91% respectively. There was a 12-hour light/dark cycle and 10-12 air changes/hour in the animal rooms. PMI Feeds Inc.Formulab #5008; was available ad libitum except for approximately 16 hours before dosing. Municipal water supply analyzed by TCEQ Water Utilities Division; was also
available ad libitum from automatic water system.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 1.67 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing.
- Doses:
- 2000 mg/kg of body weight Limit Dose.
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- Following dosing observations for mortality and clinicall behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14. On Day 14 after dosing, each animal was euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.
- Statistics:
- None required.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- There were no observable abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The rat acute oral LD50 for the test substance was determined to be > 2000 mg/kg of body weight.
- Executive summary:
The test substance, 1,2,3,6 -Tetrahydrophthalic anhydride, oligomeric reaction products with 2,2 -dimethylpropane-1,3 -diol was evaluated for acute oral toxicity in an O.E.C.D. test guideline 425 study. No mortalities occured during the study. Therefore the rat acute oral LD50 is > 2000 mg/kg of body weight.
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