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EC number: 464-300-7 | CAS number: 141645-16-1
- 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:
- 29th September 2004 to 19th October 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test item was evaluated in rats according to OECD (No. 423, 17th December 2001) and EC (2004/73/EEC, B.1 tris, 29th April 2004) guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 464-300-7
- EC Name:
- -
- Cas Number:
- 141645-16-1
- Molecular formula:
- C19H17NO5
- IUPAC Name:
- 4-(2-butyl-5-nitro-1-benzofuran-3-carbonyl)phenol
- Details on test material:
- Beige powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Number and sex: two groups of three females were used.
Age/weight: on the day of treatment, the animals were approximately 8 weeks old, and had a mean body weight ± standard deviation of 197 ± 13 g.
Acclimation: at least 5 days before the beginning of the study.
Allocation to study: before the beginning of the study, on day 1, the required number of animals was selected according to body weight and clinical condition.
Identification: individually by earnotches.
The conditions in the animal room were set as follows:
• temperature: 22 ± 2°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular
intervals.
The animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals during
the acclimation period and three rats of the same group during the treatment period.
Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
Sawdust is analyzed by the supplier for composition and contaminant levels.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose
- Control animals:
- no
- Details on study design:
- The test item was prepared in 0.5% methylcellulose and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of fasted female Sprague-Dawley rats.
The study design was as follows (as no deaths occurred in the first treated group, the results
were then confirmed in another group of three females):
Dose (mg/kg) Volume (mL/kg) Female
2000 10 3
2000 10 3
Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item.
All animals were subjected to necropsy.
The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent
adaptations).
Results and discussion
- Preliminary study:
- Dose-level of 2000 mg/kg (three females then confirmation on three other females)
No deaths occurred during the study.
Hypoactivity was observed in 3/6 females, within 2 hours of treatment.
No other clinical signs were noted during the study.
The overall body weight gain of the animals was not affected by treatment with the test item.
At necropsy, no apparent abnormalities were observed in any animal.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Hypoactivity was observed in 3/6 females, within 2 hours of treatment. No other clinical signs were noted during the study.
- Gross pathology:
- At necropsy, no apparent abnormalities were observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the oral LD50 of the test item is higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by
oral route, the test item should not be classified. - Executive summary:
Under the experimental conditions, the oral LD50 of the test item is higher than 2000 mg/kg in rats. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified.
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