6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 18, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterize

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

A representative sample of the process intermediate CP-89,575 was evaluated in rats for potential toxicity following oral exposure . The test conditions used to assess toxicity following oral administration were designed to incorporate those described by the United States Department of Transportation (DOT) under CFR Title 49, Section 173.343. These studies were also compatible with classification of the compound by the EEC according to the guidelines presented in the Official Journal of the European Communities (No. C33/18; dated 2/13/90).

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one

EC Number:

421-320-0

EC Name:

6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one

Cas Number:

118289-55-7

Molecular formula:

Hill formula: C10 H9 Cl2 N O CAS formula: C10 H9 Cl2 N O

IUPAC Name:

6-chloro-5-(2-chloroethyl)-2,3-dihydro-1H-indol-2-one

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

MOLECULAR FORMULA: C10H9Cl2NO
MOLECULAR WEIGHT: 230.09

Test animals

Species:

rat

Strain:

other: Albino Rat (Cr1:CD BR,VAF/Plus™)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 8 weeks
- Weight at study initiation: 222.7 - 230.3 g
- Fasting period before study: Overnight fast
- housed 2 or 3/cage,

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionized water containing a small amount of Tween 80 (-3 drops/10 ml).

Details on oral exposure:

Following an overnight fast, all rats were given a single oral (gavage) dose of a 100 mg/ml suspension (pH = 4.80) of the compound. The vehicle was deionized water containing a small amount of Tween 80 (-3 drops/10 ml).

Doses:

dose level, 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

The animals were observed for clinical signs of toxicity for 2 days after dosing and were weighed daily. Each animal was individually marked on the dorsal surface with an innocuous colored dye to facilitate identification. The rats were housed 2 or 3/cage, and the cages were identified with a label containing all pertinent study information. The animals were dosed on 9/16/92 (day 1) and euthanized by carbon dioxide inhalation on 9/18/92 (day 3). All rats were then necropsied
and examined for gross tissue and organ changes. Doses were calculated on a weight basis (i.e., mg compound as supplied/kg); the purity (activity) of the compound (95.6%) was not taken into consideration for dose calculations. The actual concentration and stability of the test suspension used to dose the animals were not determined.

Results and discussion

Preliminary study:

N/A

Effect levels

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0/5 deaths

Clinical signs:

other: CLINICAL OBSERVATIONS: Throughout the test period, all rats were asymptomatic, and their overall body weight gain was essentially normal. There were a few faintly orange-tinged urine stains in the cages on the morning of day 2; thereafter, the urine appea

Gross pathology:

GROSS NECROPSY: There were no gross tissue or organ changes observed in any of the rats 2 days after dosing.


at 2000
lungs - dark red
stomachal meteroism
dried blood on the muzzle
intestinal congestion
liver pale

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CONCLUSION: No deaths were produced by an oral dose of 2000 mg/kg.