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EC number: 219-342-9 | CAS number: 2420-87-3
- 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:
- 2004-05-20 to 2004-07-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-biphthalic dianhydride
- EC Number:
- 219-342-9
- EC Name:
- 4,4'-biphthalic dianhydride
- Cas Number:
- 2420-87-3
- Molecular formula:
- C16H6O6
- IUPAC Name:
- 5-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-yl)-1,3-dihydro-2-benzofuran-1,3-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- off white powder
Batch no: 2486
Constituent 1
- Specific details on test material used for the study:
- For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Strain: Sprague-Dawley CD (Crl: CD® (SD) IGS BR)
- approx. 12 weeks
- body weight: 203 - 245 g
- Fasting period before study: overnight
- Diet: ad libitum, (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK)
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 19 to 25° C
- Humidity (%): 30 to 70 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
- Air change: at least 15 change per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose: 300 and 2000 mg/kg/bw
- DOSAGE PREPARATION: the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP.
The administration volume was 10 mL/kg b.w.
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 3000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 6 female rats are treated with 2000 mg/kg b.w. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 3 female, 300 mg/kg/bw
6 female, 2000 mg/kg/bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for deaths or overt signs of toxicity 0,5, 1, 2 and 4 hours after dosing
and subsequently once daily for fourteen days.
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: At the end of the observation period the animals were killed by cervical dislocation.
All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of toxicity.
- Gross pathology:
- No abnormalities were found at necropsy.
- Other findings:
- no other findings
Any other information on results incl. tables
see attached document
Applicant's summary and conclusion
- Conclusions:
- The test substance is non toxic if swallowed, as LD50 > 2000 mg/kg b.w., p.o.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 17 December 2001).
A group of three fasted females was treated with the test material at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females (2 x 3 females) were treated at a dose level of 2000 mg/kg bodyweight. Dosing was performed sequentially. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy.
Therefore, the test substance is non toxic if swallowed, as LD50 > 2000 mg/kg b.w., p.o.
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