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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 and 24 October 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: done under GLP and OECD method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Principles of method if other than guideline:

The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (O.J. No. L383A, 29.12.92) Part C, Method 1 "Acute toxicity for Fish" and the OECD Guideline for Testing of Chemicals No. 203 "Fish, Acute Toxicity Test.

Groups of seven juvenile fish were exposed to a range of saturated solutions of CP-89,575 in water, nominally 1.0, 2.2, 4.6, 10, 22, 46 and 100%. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 3, 6, 24, 48, 72 and 96 hours exposure

GLP compliance:

yes

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:

Expiry: 2 June 1999
Purity: 98.82% by hplc
Date received: 2 June 1997

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
NA

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Test concentrations were verified by chemical analysis. Duplicate medium samples (100 ml) were taken from the control and each test concentration at 0 and 72 hours (fresh media), 24 and 96 hours (expired media) for analysis .

Test solutions

Vehicle:

no

Details on test solutions:

2 g of the test substance was added to 20 litres of diluent water in duplicate and stirred overnight using a Stuart Scientific SM8 magnetic stirrer with a I 0 em follower at approximately 250 revs/min. Following stirring the solutions were removed and filtered through a 0.45 J.lm filter. The filtrate was used as the I 00% saturated solution and appropriate volumes of this solution made up to 20 litres gave the further test solutions of I.O, 2.2, 4.6, I 0, 22 and 46% saturated

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Name:Rainbow trout
Source: Parkwood Trout Farm, Kent, UK. obtained from the supplier on 16 July 1997
Temperature: 15 °C
dissolved oxygen : within the range 8.2 to 9.2 mg0/1 in the 14-day period immediately prior to the study
Feeding: fed daily to repletion with commercial fry pellet but food was not given during the 24 hour period immediately before exposure or during the exposure period itself.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

In addition to observations on mortality at 3, 6, 24, 48, 72 and 96 hours, subjective assessments were also made on the type and incidence of sub-lethal effects compared with control fish

Test conditions

Hardness:

The water used for the study was laboratory tap water filtered, dechlorinated and softened by passage through an Elga® water purification system.A proportion of the supply then passes through a water softener before final reverse osmosis treatment to produce a highly purified water supply. The two grades of dechlorinated water are then remixed in the ratio of approximately 1 : 1 to give a supply with the desired water hardness
.148 and 164 mgCaC0/1

Test temperature:

maintained at 14 °C throughout the exposure period

pH:

Between 7.6 and 8

Dissolved oxygen:

Between 8.9 and 9.5

Salinity:

No data

Nominal and measured concentrations:

Mean measured concentrations: 0.025, 0.056, O.II, 0.25, 0.56, 1.2 and 2.5 mg/1

Details on test conditions:

Supplementary aeration was provided via narrow bore glass tubes in this study. A photoperiod of 16 h light : 8 h dark was maintained and daily records of temperature.The fish were not fed during the 96 hour exposure period.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 2.5 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 1.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No mortalities were observed during the exposure period. However, marked reactions to exposure (other than death) were increased pigmentation in the 100% saturated level

Results with reference substance (positive control):

NA

Reported statistics and error estimates:

No Data

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 96 h LC50 value for CP-89,575 with rainbow trout was >2.5 mg/1, the highest mean measured concentration achieved in this study.

The 'no-observed effect concentration' for CP-89,575 with rainbow trout was 1.2 mg/1.