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EC number: 935-121-6 | CAS number: 1253789-90-0
- 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
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- propan-2-yl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- EC Number:
- 935-121-6
- Cas Number:
- 1253789-90-0
- Molecular formula:
- C18 H23 N O2
- IUPAC Name:
- propan-2-yl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CD00006066XX ( BI 207127SE )
- Physical state: yellow powder
- Storage condition of test material: room temperature
- Lot/batch No.: 7330-038-2
- Expiration date of the lot/batch: Feb. 2007
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 209 - 363 g
- Fasting period before study: overnight prior to dose administration
- Housing: Animals were group housed by sex upon receipt and individually housed upon assignment to study.
- Diet (e.g. ad libitum): Harlan Tekland Rodent Diet ad libitum
- Water (e.g. ad libitum): Tap water was available ad libitum, to each animal via an automatic watering device.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 21 - 68
- Photoperiod (hrs dark / hrs light): 12 : 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: hydroxyethylcellulose in deionized water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose levels were selected by the Sponsor based on regulatory guidelines and the intended use of
the test article. - Doses:
- 300 mg/kg body weight
2000 mg/kg body weight - No. of animals per sex per dose:
- 3 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations : Mortality - once daily
Body weight - Day 1, 8 an d15,
Clinical Observation - 30 min, 1 and 4 hours after dosing and once daily trough day 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in the animals at 200 and 3000 mg/kg.
- Clinical signs:
- other: Abnormal gait and stance were observed at 4 hours in the males dosed with the test article at 300 mg/kg. No other clinical signs observed in the animals at 300 or 2000 mg/kg at any other time during the study.
- Gross pathology:
- No visible lesions were observed in any of the animals at 300 or 2000 mg/kg at terminal necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to the Globally Harmonized Classification system, CD00006066XX administered orally at dose levels of 300 and 2000 mg/kg body weight
in male and female rats was considered to be a Category 5 test substance with an LD50 greater than 2000 - 5000 mg/kg. - Executive summary:
Objective
This study was designed to assess the toxicity of CD00006066XX following a single dose to the rat. The results of the study are believed to be of value in predicting the likely toxicity in man by oral route.
Methods
One group of three female Wistar rats were orally administered CD00006066XX via oral gavage at 300 mg/kg. Due to the lack of mortality observed, an additional group of three males was administered the test article at 300 mg/kg. Two groups ( 3 female followed by 3 male ) were also dosed at 2000 mg/kg.
Results
No mortality was observed in any of the animals at 300 or 2000 mg/kg. Abnormal gait and stance were observed at 4 hours in the males dosed with the test article at 300 mg/kg. No other clinical signs observed in the animals at 300 or 2000 mg/kg at any other time during the study. All animals at 300 and 2000 mg/kg gained weight throughout the study. No visible lesions were observed in any of the animals at 300 or 2000 mg/kg at terminal necropsy.
Conclusion
According to the Globally Harmonized Classification system, CD00006066XX administered orally at dose levels of 300 and 2000 mg/kg body weight in male and female rats was considered to be a Category 5 test substance with an LD50 greater than 2000 - 5000 mg/kg.
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