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EC number: 700-867-1 | CAS number: -
- 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:
- 2001-07-18 to 2001-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- : This study was performed in compliance with the Swiss Ordinance relating to Good Laboratory Practice, adopted February 2nd, 2000 [RS 813.016.5].
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- rel-(4aR,8aR)-1-bromo-3-methoxy-4a,5,9,10,11,12-hexahydro-6H-[1]benzofuro[3a,3,2-ef][2]benzazepin-6-one hydrochloride (1:1)
- EC Number:
- 700-867-1
- Molecular formula:
- C16H16BrNO3.HCl
- IUPAC Name:
- rel-(4aR,8aR)-1-bromo-3-methoxy-4a,5,9,10,11,12-hexahydro-6H-[1]benzofuro[3a,3,2-ef][2]benzazepin-6-one hydrochloride (1:1)
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study reports): T002102
- Physical state: solid
- Appearance: white (SDS)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RT002102G4A311
- Expiration date of the lot/batch: 25-MAR-2002
- Purity:99.4%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability of the test substance in the solvent/vehicle: 2 hours
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HanBrl:WIST (SPF), RCC Ltd. Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf, Switzerland
- Age at study treatment: 9 weeks (males); 12 weeks (females)
- Weight at study initiation: males: 229.5-257.7 g; females: 202.3-215.4 g
- Fasting period before study: no data
- Housing: During acclimatization, animals were housed in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. During treatment and observation animals were individually housed in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: ad libitum, pelleted standard Provimi Kliba 3433, batch no. 72/01 rat maintenance diet
- Water: ad libitum, community tap water from Itingen
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12hrs light/12 hrs dark, music during the light period
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG300
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of the animals was clipped with an electric clipper. On test day 1, 2000 mg/kg bw evenly on the intact skin with a syringe and covered with a semi-occlusive dressing.
- % coverage: 10 % of the total body surface
- Type of wrap if used: A dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL volume/body weight
- Concentration (if solution): the test substance was diluted in polyethylene glycol (PEG 300) at a concentration of 0.5 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: no
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male/female rats per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
- mortality/viability: daily during acclimatization and at least 1, 2, 3 and approximately 5 hours after the test item administration. Twice daily during days 2-15.
- body weight: on test days 1(pre-administration), 8, 15
- clinical signs: daily during acclimatization and at least 1, 2, 3 and approximately 5 hours after the test item administration. Once daily during days 2-15
- Necropsy of survivors performed: At the end of the observation period all animals were sacrificed by intraperitoneal injection of Narcoren at a dose of at least 2.0 mL/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded. - Statistics:
- No statistical analysis were used.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period
- Gross pathology:
- No macroscopic findings were observed at necropsy
Any other information on results incl. tables
The results of the dose verification analysis were 98.8, 97.7 and 95.8 % of nominal for samples taken from the top, middle and bottom of the mixing container. The individual concentrations varied in the range from -2 % to +1 % of the mean concentrations. Since the concentrations were found to be within the accepted range of 80 - 120 % of the nominal concentration, it was determined that the test substance was homogeneously distributed in the vehicle. The test substance was found to be stable in the vehicle under storage conditions over a period of two hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose after a single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight. Therefore, the substance should not be considered to be classified according to CLP regulation.
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