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Diss Factsheets
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EC number: 270-485-3 | CAS number: 68442-68-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed similar to OECD 401.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP implementation
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Benzenamine, N-phenyl-, styrenated
- EC Number:
- 270-485-3
- EC Name:
- Benzenamine, N-phenyl-, styrenated
- Cas Number:
- 68442-68-2
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- 4-(1-phenylethyl)-N-[4-(1-phenylethyl)phenyl]aniline
- Test material form:
- liquid: viscous
- Details on test material:
- - Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar-II, SPF
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder Winkelmann
- Weight at study initiation: 160-180g
- Housing: 5 animals / cage
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Lutrol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2ml/kg
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 1, 2, 3, 4, 5, 6, 7, 14
- Other examinations performed: clinical signs, bodyweight - Statistics:
- Calculation of LD50 according to Fink and Hund, Arzneim.-Forsch. 15, 1965, 624
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortalities observed
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortalities observed
- Mortality:
- none
- Clinical signs:
- other: no symptoms observed on any observation day
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted with a scientifically reasonable study design similar to OECD 401 on the registered substance itself with acceptable deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the toxicity of the test item towards rats. No rats died or showed symptoms at a dose of 5 g/kg bw, so the substance can be considered as relatively harmless and no classification as acute toxic according to Regulation 1272/2008 is triggered.
- Executive summary:
In an acute oral toxicity study similar to OECD 401, groups of young male Wistar-II-rats (10/dose) were given a single oral dose of the test item in Lutrol at a limit dose of 5000 mg/kg bw and observed for 14 days.
Oral LD50Males > 5000 mg/kg bw
Oral LD0Males ≥ 5000 mg/kg bw
No mortalities occurred and no symptoms were observed at this dose. The test item is of low Toxicity based on the LD50 in males. No classification as acute toxic according to Regulation 1272/2008 is triggered.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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