Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 936-073-9 | CAS number: 1253791-42-2
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:
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- propan-2-yl 2-bromo-3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- EC Number:
- 936-073-9
- Cas Number:
- 1253791-42-2
- Molecular formula:
- C18 H22 Br N O2
- IUPAC Name:
- propan-2-yl 2-bromo-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): CD00006062XX ( BI 207127SE )
- Physical state: withe powder
- Storage condition of test material: room temperature
- Lot/batch No.: BIC 11008957 ( Exp. Mar 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: 8 - 12 weeks
- Weight at study initiation: 206 - 362 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 ad libitum
- 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:
- three male and three female animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations : - Mortality: once a daily
- Clinical Observation :30 min, 1 and 4 hours after dosing and once daily through Day 15
- 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 - 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in the animals at 300 or 2000 mg/kg.
- Clinical signs:
- other: No clinical signs observed in the animals at 300 or 2000 mg/kg.
- 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, CD00006062XX 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 LD50 greater than 2000 - 5000 mg/kg. - Executive summary:
Objective
This study was designed to assess the toxicity of CD00006062XX 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 CD00006062XX via oral gavage at 300 mg/kg. Due to the lack of mortality observed, an additional group of three male rats was administered the test article at 300 mg/kg. Two groups ( 3 female followed by three male ) were also dosed with 2000 mg/kg.
Results
No mortality and no clinical signs were observed in any of the test animals. All animals gained weight throughout the study. No visible lesions were observed in any of the animals at terminal necropsy.
Conclusion
According to the Globally Harmonized Classification System, CD00006062XX 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 LD50 greater than 2000 - 5000 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
