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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4th November 2004 to 18th November 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with: • OECD guideline No. 402, 24th February 1987, • EC Directive No. 92/69/EEC, B.3, 31st July 1992.
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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- 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:
- male/female
- Details on test animals or test system and environmental conditions:
- Number and sex: one group of ten animals (five males and five females). Females were nulliparous and non-pregnant.
Age/weight: on the day of treatment, the animals were approximately 8 weeks old and had a mean body weight ± standard deviation of 333 ± 15 g
for the males and 214 ± 4 g for the females.
Acclimation: at least 5 days before the beginning of the study.
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.
During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm).
During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
Sawdust is analyzed by the supplier for composition and contaminant levels.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No clinical signs, no deaths and no cutaneous reactions were observed during the study.
A reduced body weight gain was seen in 1/5 females between day 8 and day 15.
The overall body weight gain of the other animals was similar to that of CIT historical control animals.
No apparent abnormalities were observed at necropsy in any animal. - Duration of exposure:
- The test site was covered by a semi-occlusive dressing for 24 hours.
- Doses:
- The application was performed with the test item in its original form at the dose-level of 2000 mg/kg.
- No. of animals per sex per dose:
- The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and
five females). - Control animals:
- no
- Details on study design:
- As the test item was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by application of 2000 mg/kg of the test item to one
group of ten animals (five males and five females).
Results and discussion
- Preliminary study:
- Under the experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.
Effect levels
- Sex:
- male/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: No clinical signs and no cutaneous reactions were observed during the study.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.
- Executive summary:
Under the experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.
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