1H-Indole-6-carboxylic acid, 3-cyclopentyl-1-methyl-, 1-methylethyl ester

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:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 3

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

Test material information

Constituent 1

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

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.