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EC number: 439-750-2 | CAS number: 183487-56-1
- 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:
- August 1st, 2001 to August 22nd, 2001
- 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:
- in compliance with the Swiss Ordinance relating to GLP, adopted February 2nd, 2000 [RS 813.016.5] and based on the OECD Principles of GLP, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97)186/Final]
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 439-750-2
- EC Name:
- -
- Cas Number:
- 183487-56-1
- Molecular formula:
- Hill formula: C17H19BrClNO3 CAS formula: C17H19BrClNO3
- IUPAC Name:
- (4aR*,8aR*)-1-bromo-4a,5,9,10,11,12- hexahydro-3-methoxy-11-methyl-6H-ben zofuro[3a,3,2-ef][2]benzazepin-6-one hydrochloride
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): T002113
- Substance type: powder
- Physical state: solid
- Analytical purity: 92.9 %
- Purity test date: no data
- Lot/batch No.: RT002113G3A231
- Expiration date of the lot/batch: 1-dec-2001
- Storage condition of test material: at room temperature (range of 20 +/- 3 °C), away from direct sunlight
- Stability of test item: stable under storage conditions
- Stability of test item in vehicle: 2 hours , the concentration, homogeneity, and stability of T002113 was determined (see further)
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 10 rats (5 males and 5 females), RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf, Switzerland
- Age when treated: 9 weeks for males, 12 weeks for females
- Weight at study initiation: 224.0-245.5 g for males, 201.6-208.1 g for females
- Housing: during acclimatization in groups of 5 per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz, Switzerland) during treatment and observation.
- Diet (e.g. ad libitum): ad libitum, pelleted standard Provimi Kliba 3433, batch no. 72/01 rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst). Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): ad libitum, community tap water from Itingen. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: 7 days, 1-aug to 7-aug-2001 (males and females) (under laboratory conditions)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs fluorescent light (light period between 6.00 and 18.00), music during light period
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: bi-distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the back of the animal
- % coverage: approximately 10 % of the total body surface
- Type of wrap if used: semi-occlusive dressing, the dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight in 4 ml/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 ml/kg body weight - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 2 x 5 (5 males and 5 females)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and viability daily during acclimatization period and twice daily during days 1-15. Body weights on test days 1 (pre-administration), 8 and 15. Clinical signs daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15.
- Necropsy of survivors performed: yes, at the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, 0-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight).
- All animals were examined macroscopically - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- 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.
- Body weight:
- other body weight observations
- Remarks:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of T002113 after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight
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