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

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:

3-cyclopentyl-1H-indole-6-carboxylic acid

Cas Number:

494799-36-9

Molecular formula:

C14 H15 N O2

IUPAC Name:

3-cyclopentyl-1H-indole-6-carboxylic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): CD 6002 SE
- Physical state: white powder
- Storage condition of test material: room temperature, protected from light
- Analytical purity: 99.7 %
- Lot/batch No.: TSA-05-003

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 233 - 253 g ; female 231 - 240
- Fasting period before study: 17 - 20 h
- Housing: Animals were 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:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

2000 mg/kg body weight
300 mg/kg body weight

No. of animals per sex per dose:

3 female per 2000 mg/kg
3 female and 3 male per 200 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : - Clinical observations : 1, 4,6 hours after application on Day 1, than once daily
- Body weight : Day 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

300 - 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Three females dosed at 2000 mg/kg were sacrificed in a moribund condition following the 4-hour postdose observations, therefore, three female
and three male rats were dosed at 300 mg/kg. At 300 mg/kg, all rats survived to study termination ( Day 16).

Clinical signs:

other: Clinical observations noted in the 2000 mg/kg females during the continuous 1-hour observations included : hunched posture, hypoactivity, ataxia, clear oral discharge, irregular and labored respiration, squinted eyes, and sternal recumbency. Observation

Gross pathology:

No abnormal findings were noted in any animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

According to the Globally Harmonized Classification System, CD 6002 SE administered orally at a dose of 300 mg/kg body weight in male and female rats under the conditions of this study is considered to be a Categorie 4 test article ( i.e., the oral LD50 of CD 6002 SE in rats is greater than
300 mg/kg and less than 2000 mg/kg).

Executive summary:

The toxicity of the test article, CD 6002 SE, was evaluated following a single oral dose to rats based on the OECD Guideline No. 423.

A limit-test was conducted using a step-wise procedure. Three females received the test article suspended in 1 % carboxymethylcellulose / 0.2 % Tween 80 at 2000 mg/kg body weight followed by three females and three males dosed at 300 mg/kg body weight. Doses were administered at a dose volume of 20 mL/kg based on the most recent body weights. Toxicity was evaluated based on mortality, clinical observations, body weights, and macroscopic observations.

Three females dosed at 2000 mg/kg were sacrificed in a moribund condition following the 4-hour postdose observations, therefore, three female and three male rats were dosed at 300 mg/kg. At 300 mg/kg, all rats survived to study termination ( Day 16).

Clinical observations noted in the 2000 mg/kg females during the continuous 1-hour observations included : hunched posture, hypoactivity, ataxia, clear oral discharge, irregular and labored respiration, squinted eyes, and sternal recumbency. Observations noted at 4 hours postdose prior to sacrifice included : hypoactivity, irregular and/or labored respiration, sternal recumbency, and lacrimation. Clinical observations noted in the 300 mg/kg females during the continuous 1-hour observations included :hunched posture, hypoactivity, ataxia, and squinted eyes. Clinical observations noted in the 300 mg/kg females at 4 hours postdose included slight hypoactivity piloerection. At the 300 mg/kg dose level, the males appeared normal at all postdose observation intervals and females appeared normal at the intervals beginning at 6-hours postdose.

All animals dosed at 300 mg/kg had normal weight gain from initiation of dosing to study termination. No abnormal findings were noted in any animals at necropsy.

In conclusion, according to the Globally Harmonized Classification System, CD 6002 SE administered orally at a dose of 300 mg/kg body weight in male and female rats under the conditions of this study is considered to be a Categorie 4 test article ( i.e., the oral LD50 of CD 6002 SE in rats is greater than 300 mg/kg an less than 2000 mg/kg).