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Diss Factsheets
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EC number: 204-251-9 | CAS number: 118-45-6
- 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
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-chlorophthalic anhydride
- EC Number:
- 204-179-8
- EC Name:
- 3-chlorophthalic anhydride
- Cas Number:
- 117-21-5
- Molecular formula:
- C8H3ClO3
- IUPAC Name:
- 4-chloro-2-benzofuran-1,3-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Outbred albino (Rattus norvegicus)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Five female outbred albino rats were received from Harlan, Inc. Indianapolis, IN. They weighed 202.7-214.8 g and were at least 49 days old. They were single housed upon arrival in polycarbonate cages with hardwood chip bedding. The animals were acclimated for at least 5 days prior to dosing. Tap water was provided ad libitum throughout the study and feed was provided ad libitum, with the exception of overnight prior to dosing. The temperature and humidity were maintained at 68±5°F and 30-70%, respectively. Room lights were on a 12-hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- 3-CLPA was a solid and was dosed as a suspension in cottonseed oil. The volume did not exceed 1 mL/100 g body weight.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- Food was withheld from the animals the night prior to dosing. Animals were administered a single dose of 3-CLPA by oral gavage. After dosing, the animals were returned to their cages and supplied with feed and water ad libitum.
The first animal was dosed at 2000 mg/kg. As the animal survived, the limit test was continued at the dose of 2000 mg/kg and the main test was not conducted. Four additional animals were dosed sequentially.
Careful clinical observations were made at least twice on the day of dosing. Special attention was given during the first four hours. Animals were observed daily for 14 days for clinical manifestations. Animals were weighed on Day 0, prior to dose administration, Day 7 and Day 14.
A gross necropsy was performed on all animals sacrificed at the end of the study.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived to study termination.
- Clinical signs:
- other: No clinical manifestations of toxicity were observed over the course of the study.
- Gross pathology:
- No unusual findings were found during necropsy in all dosed animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was determined to be > 2000 mg/kg body weight.
- Executive summary:
Acute toxicity was determined in a study performed according to OECD 425 and in compliance with GLP criteria. In this study, 5 female Outbred albino (Rattus norvegicus) rats were exposed to a test concentration of 2000 mg/kg, which was administered orally gavage. Detailed clinical observations were made at least twice on the day of dosing with special attention in the first few hours, followed by daily observations for a period of 14 days. Observations included the incidence and severity of all abnormalities, including behavioral and clinical abnormalities, gross lesions, bodyweight changes, effects on mortality, and any other toxic effects. No effects were seen on survival and no clinical signs were observed. Furthermore, the animals gained weight during the study and no unusual findings were observed at necropsy. The LD50 was determined to be >2000 mg/kg body weight.
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