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

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 - 30 October 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Done under GLP and OECD methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Method C3, Directive 92/69/EEC

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Principles of method if other than guideline:

A study was conducted to assess the inhibitory effect of CP-89,575 on the growth of the unicellular green alga Selenastrum capricornutum, Strain No. CCAP 278/4.Triplicate algal cultures were exposed to ten saturated solutions of CP-89,575 in algal media, nominally ranging from 0.1, 0.22, 0.46, 1.0, 2.2, 4.6, 10, 22, 46 and 100%, plus one untreated control. Solutions were prepared by filtration and dilution of a saturated solution stirred overnight. The highest test level (100% saturated) was the undiluted filtrate. Cultures were incubated in a Gallenkamp Orbital Incubator under continuous illumination at 24°C for 72 hours. Cell numbers were counted daily to monitor growth

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:

Intended use: Pharmaceutical intermediate
Appearance: Off-white powder
Storage conditions: Room temperature in the dark







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):
No data

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: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 for analysis
- Sampling method:Additional samples were also taken from flasks containing the test substance at a concentration equivalent to the highest exposure concentration but with no algae present, at 0 hours and at 72 hours (replicates pooled), in order to obtain information on the extent of adsorption/absorption of the test substance by the algal cells

Test solutions

Vehicle:

no

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: acetonitrile : water (50:50 v/v)

Test organisms

Test organisms (species):

Scenedesmus capricornutum

Details on test organisms:

TEST ORGANISM
- Common name:Scenedesmus capricornutum
- Strain:CCAP 278/4
- Source (laboratory, culture collection):Culture Collection of Algae & Protozoa, Institute of Freshwater Ecology, Cumbria, UK.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

Cell numbers were counted daily to monitor growth.

Test conditions

Hardness:

NO data

Test temperature:

The temperature was maintained at 24 ± 1°C

pH:

No data

Dissolved oxygen:

No data

Salinity:

No data

Nominal and measured concentrations:

Geometric mean measured concentrations: 0.0019, 0.0043, 0.0095, 0.022, 0.044, 0.077, 0.24,
0.61, 1.4and3.1 mg/1

Measured concentrations ranged from 86.1 to 103% of target dilution factor at 0 hours and 33.4 to 105% of target dilution factor at 72 hours.

Details on test conditions:

Conical flasks (250 ml) each containing 100 ml of test or control culture were loosely stoppered and placed without conscious bias in a Gallenkamp Illuminated Orbital Incubator. The cultures were incubated, without medium renewal, for 72 hours under continuous illumination of approximately 7000 lux provided by 7 x 30 W "universal white" 1 metre fluorescent tubes. The temperature was maintained at 24 ± 1°C. Gaseous exchange and suspension of the algal cells were ensured by the action of the orbital shaker, oscillating at 120 cycles per minute

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

1.2 mg/L

Conc. based on:

test mat.

Basis for effect:

biomass

Remarks on result:

other: 95%

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 3.1 mg/L

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

0.077 mg/L

Conc. based on:

test mat.

Basis for effect:

biomass

Details on results:

Comparison of the measured concentrations of the test substance obtained from medium samples at a concentration equivalent to the highest test concentration, but without the addition of algal cells, indicated that the presence of algal cells had affected the stability of the exposure solutions.The

A

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 0-72hr ErC50 of test substance was calculated to be >3.1 mg/l and NOEC 0.077mg/l.