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EC number: 214-874-8 | CAS number: 1204-28-0
- 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:
- From January, 31 1996 to March, 21 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Well described study performed according to a standardised method with acceptable deviations. Acceptablme for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Only males were tested. No necropsies were performed.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl chloride
- IUPAC Name:
- 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Trimellitic anhydride mono-chloride (product name: TAC)
- Physical state: Light yellow solid
- Storage condition of test material: Cool place preservation
-Supplier: Nippon Fine Chemical
Constituent 1
- Specific details on test material used for the study:
- 4-chloroformylphthalic anhydride
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc
- Age at study initiation: 5-week old
- Weight at study initiation: 130.4 - 166.3g
- Fasting period before study: at least for 16 hours on the day before treatment
- Diet (e.g. ad libitum): cubed diet (the Funabashi farm, F-2)
- Water (e.g. ad libitum): tap water from town water
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 45-65
- Air changes (per hr): 15 to 25 air change rates/hour
- Photoperiod (hrs dark / hrs light): lighting 12 hours/day (7:00 to 19:00)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% w/v
DOSE VOLUME APPLIED: 5.4 - 20.0 ml/kg - Doses:
- 1347, 1751, 2276, 2959, 3846, and 5000mg/kg (common ratio 1.3)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily (each morning). During the first day after exposure, observations were made immediately after ingestion and then at 30 min, 1 hour, 2 hours and 4 hours after ingestion.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 192 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 744 - 3 773
- Mortality:
- 100% mortality at the highest tested dose of 5000 mg/kg during the first day after ingestion.
0% mortality observed at 2276 mg/kg.
All dead were observed during the first 3 days after ingestion. - Clinical signs:
- other: At 1347 mg/kg during the first day of exposure salivation was observed on 5 animals , lacrimation was observed on 2 animals and loose stool was observed on 5 animals. At 1751 mg/kg, main clinical effects are diarrhea which was observed on 2 animals and lo
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Trimetillic anhydride mono-chloride is estimated 3192 mg/kg bw in male rats. The LD50 is above 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study, performed according to a standard method equivalent to the OECD 401 Guideline, the substance 4 -chloroformylphthalic anhydride (TMAC) was administered by oral gavage, to male Sprague-Dawley rats at the doses of 1347, 1751, 2276, 2959, 3846, and 5000 mg/kg (5 animals/dose level). The test substance was diluted in olive oil. Clinical signs were checked for a period of up to 14 days.
Oral LD50in male rats = 3192 mg/kg bw
Clinical effects were observed at all tested doses. Animals died at concentrations from 2959 mg/kg to 5000 mg/kg.
Clinical effects observed were salivation, lacrimation, diarrhea or loose stool, hematuria, decrease in locomotor movement and decrease in respiration. All survival animals recovered from clinical signs after 5 days.
Based on the results of this study, 4 -chloroformylphthalic anhydride is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) but is classified Acute Toxicity Oral Category 5 according to the UN GHS Regulation. This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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