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EC number: 690-920-4 | CAS number: 494799-38-1
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- Cas Number:
- 494799-38-1
- Molecular formula:
- C16 H19 N O2
- IUPAC Name:
- methyl 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): CD 6003 XX
- Physical state: light yellow powder with chunks
- Storage condition of test material: room temperature, protected from light
- Analytical purity : 99.7 %
- Lot/batch No.: T1031
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories,Raleigh, North Carolina
- Age at study initiation: 8 - 11 weeks
- Weight at study initiation: male 247 - 267 g , female 208 - 230 g
- Fasting period before study : 17 - 20 h
- Housing: Individually housed in sanitary, suspended, screen bottom, stainless steel cages. .
- Diet (e.g. ad libitum): Certified Rodent Diet #5002 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12 : 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Tween 80 in WFCCA
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 2000 mg/kg body weight
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg - Doses:
- 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: 14 days
- Frequency of observations: - Clinical observations : twice daily
- Body weight : Days 1, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Three female and three male rats dosed at 2000 mg/kg body weight survived to study termination ( Day 16 ).
- Clinical signs:
- other: On day 1, during the 1-hour continuous observations ( male rats ) : slight hypoactivity, hunched posture, squinted eyes and hypoactivity. In addition, one male had labored, audible respiration. At the 4-hour postdose observation, one male had slight hyp
- Gross pathology:
- One female had distended intestines and purple spots on the mandibular lymph nodes, no other abnormal findings were noted in any animals at
necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, according to the Globally Harmonized Classification System, CD 6003 XX administered orally at a dose level of 2000 mg/kg body
weight in male and female rats under the conditions of this study is considered to be a Category 5 test article ( i.e., the oral LD50 of CD 6003 XX in
rats is greater than 2000 mg/kg). - Executive summary:
The toxicity of the test article, CD 6003 XX, was evaluated following a single dose to rats based on the OECD Guidelines No. 423.
A limit test was conducted using a step-wise procedure.Three female rats received the test article suspended in 1 % carboxymethylcellulose/0.2 % Tween 80 at 2000 mg/kg body weight. Doses were administered at a dose volume of 10 mL/kg based on the most recent body weight.
All rats survived to study termination ( Day 16 ).
Clinical observations noted on Day 1, during the 1-hour continuous observations, were limited to males and included : slight hypoactivity, hunched posture, squinted eyes and hypoactivity. In addition, one male had labored, audible respiration. In addition, one male had labored, audible respiration. At the 4-hour postdose observation, one male had slight hypoactivity. No clinical observations were noted at 6 hours postdose. On day 8, one female had red genital discharge. On day 15, two females had alopecia ( right inguinal or left marginal sacral areas ). All animals had normal weight gain from initiation of dosing to study termination. One female had distended intestines and purple spots on the mandibular lymph nodes, no other abnormal findings were noted in any animals at necropsy.
In conclusion, according to the Globally Harmonized Classification System, CD 6003 XX administered orally at a dose level of 2000 mg/kg body weight in male and female rats under the conditions of this study is considered to be a category 5 test article ( i.e., the oral LD50 of CD 6003 XX in rats is greater than 2000 mg/kg).
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