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EC number: 402-130-7 | CAS number: 106246-33-7
- 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:
- September 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 402-130-7
- EC Name:
- -
- Cas Number:
- 106246-33-7
- Molecular formula:
- C21 H28 Cl2 N2
- IUPAC Name:
- 4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline
- Details on test material:
- - Substance code: P5367
- Batch No.: 1/86
- Appearance: Off-white to yellowish powder
- Storage: At ambient temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: stable
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age: 6 - 8 weeks
- Weight at study initiation: 215 - 305 g
- Housing: groups of 5 by sex in suspended polypropylene cages
- Diet: Special Diet Services Expanded Rat and Mouse Maintenance Diet No. 1
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23°C
- Humidity: mean 51%
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- The test material, at a dose level of 2000 mg/kg, was applied evenly onto the prepared gauze dressing and wetted with distilled water. The dressing was then applied to the shaved back of each rat with approximately 10% of the body surface in contact with the test material. The trunk of the rat was then encircled with a strip of non-irritating tape (Sleek).
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Each rat was individually housed for a contact period of 24 hours following application, after which the dressing was removed and the skin wiped with a damp tissue to remove excess material. The rats were then returned to their original cages. The rats were observed frequently on the day of dosing and for 14 days following dosing. They were weighed immediately prior to dosing, 7 days after dosing and at death or sacrifice at the end of the 14 day
observation period. At death or at the end of the observation period and sacrifice by nitrogen asphyxiation, each animal was subjected to a gross post mortem.
- ;
Results and discussion
- Preliminary study:
- no pre-test performed
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- MALES:
- 2000 mg/kg bw: No mortality observed in males.
FEMALES:
- 2000 mg/kg bw: No mortality observed in females - Clinical signs:
- other: No deaths and no clincal signs of toxicity observed.
- Gross pathology:
- No effects on organs observed.
- Other findings:
- No signs of local toxicity observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 on Sprague-Dawley rats (both sexes) was found to be > 2000 mg/kg.
- Executive summary:
The study was performed 1986 as GLP-test following EU-testing method B.3. The used species were Sprague-Dawley rats; 5 males and 5 females were treated with a single dose of 2000 mg/kg. The test item was moistened with distilled water and applied by occlusive dressing. Neither clinical signs nor effects on organs were noted. Body weight gains were lower than expected, particularly in females.
In conclusion, the acute dermal LD50 was determined to be > 2000 mg/kg.
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