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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 22 and 24 January 1997
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: Method C2, Directive 92/69/EEC
Principles of method if other than guideline:
Groups of twenty, first instar Daphnia, less than 24 hours old, were exposed to UK-143, 108 for 48 hours at nominal concentrations of 1.0, 2.2, 4.6, 10, 22, 46 and 100 mg/I dissolved in Elendt M4 medium. The numbers of immobilised daphnids were recorded for each test and control group after 24 and 48 hours and the following values were determined. All results are expressed in terms of nominal concentration
GLP compliance:

Test material

Constituent 1
Details on test material:
Intended use: Pharmaceutical intermediate
Appearance: White to off-white powder
Storage conditions: Room temperature in the dark
Expiry date: Not supplied
Purity: 101.3%
Date received: 2 October 1996
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):

Sampling and analysis

Analytical monitoring:
Details on sampling:
Test concentrations were verified by chemical analysis. Samples, 50 ml, were taken from the pooled replicates of control and each test concentration at 0 hours and after 48 hours and were sent to the Huntingdon Life Sciences Department of Ecotoxicology, Analysis Section (see Verification of Test Concentrations).

Test solutions

Details on test solutions:
Preliminary range finding tests were conducted using test concentrations of 0.1 to 1000 mg/I, under similar exposure conditions to those subsequently employed in the definitive test. The results of these preliminary range finding tests indicated the test substance was of low toxicity to Daphnia at these concentrations

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Source: Institute National de Recherche Chimique Applique (IRChA), France
Stock cultures of Daphnia magna were maintained in glass vessels containing approximately 800 ml of Elendt M4 culture medium with a 16 hour light: 8 hour dark photoperiod at 20 ± 1°C. Cultures were fed daily with a suspension of the unicellular green alga, Chlorella vulgaris. Culture conditions ensured that cultures reproduce by parthenogenesis.

The day before the start of the study, all juvenile Daphnia were removed from the laboratory cultures. The following morning, juveniles produced by the gravid (egg-bearing) adult Daphnia were removed from the culture vessels and held in a separate holding vessel; these animals, which were less than 24 hours old, were used in the test

Study design

Test type:
Water media type:
Limit test:
Total exposure duration:
48 h
Remarks on exposure duration:
without renewal of test media.
Post exposure observation period:
The temperature in each vessel was measured daily and the pH and dissolved oxygen levels recorded at the start and at the end of the study

Test conditions

No Data
Test temperature:
20 ± 1 °C,
Maintained between 7.28 and 7.68
Dissolved oxygen:
Between 8.33 and 8.45 mg/l
No Data
Nominal and measured concentrations:
Nominal test concentrations: 1.0, 2.2, 4.6, 10, 22, 46 and 100 mg/I
Mean measured test concentrations: 1.02, 2.25, 4.75, 10.0, 21.5, 44.5 and 93.7 mg/I

Details on test conditions:
Seven duplicate concentrations were prepared with one untreated control. The test vessels were 250 ml capacity glass jars.

Ten first instar Daphnia were placed without conscious bias into glass jars, each containing 200 ml of prepared test medium or diluent medium only to give a loading of 20 ml test solution per organism. The jars were loosely covered to minimise evaporative losses.
Reference substance (positive control):
not specified

Results and discussion

Effect concentrationsopen allclose all
24 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
48 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
Details on results:
Measured concentrations ranged from 101 to 103% of nominal at 0 hours and 86.4 to 104% of nominal at 48 hours
Highest test concentration resulting in 0% immobilisation: 100 mg/I*
Lowest test concentration resulting in 100% immobilisation: > 100 mg/I

Results with reference substance (positive control):
Reported statistics and error estimates:
If appropriate, EC10 values were calculated using a logistic model (Berkson, 1944) for which 95% confidence limits were estimated by the likelihood ratio method (Williams, 1986).

Applicant's summary and conclusion

Validity criteria fulfilled:
The 48 h EC50 (immobilisation value for UK-143,108 with Daphnia magna was determined to be
>100 mg/I, the highest concentration tested.