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

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:

2005

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

Test material information

Constituent 1

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

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).