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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study plan 09 November 2000, Final report 27 February 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP
Cross-reference
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appendix to the EU-Guideline 92/69/EWG from 31 July 1992
Principles of method if other than guideline:
The Daphnia are exposed to the test substance added to water at a range of concentrations for 48 hours. Under otherwise identical test conditions, and an adequate range of test substance concentrations, different concentrations of a test substance exert different average degrees of effect on the swimming ability of Daphnia. Different concentrations result in different percentages of Daphnia being no longer capable of swimming at the end of the test. The concentrations causing zero or 100% immobilisation are derived directly from the test observations whereas the 48-hour EC50 is determined by calculation if possible.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Active Matter = 98,4 %
Substance-No.: SAT 000926
Batch-No.: GN 1-56 39/62-88

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
A stock solution of 1 g test material per litre M4-medium was prepared. from this solution a second clear stock solution was prepared by 1:100 dilution. Appropriate volumes were taken from the second solution, tranferred into the test vessels and filled up to about 40 ml with M4-medium. The end volume of 50 ml was adjusted after the transfer of the test organisms into the test vessels.
At the test start the test solutions were clear. With increasing test substance concentration (3 mg/L and more) and with increasing test duration increasing precipitation was observed.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
The test organims were obtained as ephippia in december 2000 from Creasel, 98000 Deinze, Belgium.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
Sythetic mineral water M4-medium according to Elendt
Test temperature:
20 °C
pH:
test concentration (mg/L)
(nominal) pH
0 8.0
0.1 8.0
0.3 8.0
1 7.9
3 7.9
10 7.9
30 7.8
100 7.8
Dissolved oxygen:
test concentration (mg/L)
(nominal) oxygen saturation (%)
0 98
0.1 98
0.3 98
1 98
3 98
10 97
30 97
100 97
Salinity:
Sythetic mineral water M4-medium according to Elendt
Nominal and measured concentrations:
nominal concentration measured concentration (mg/L)
(mg/L) 0h 24h 48h
1 <1 <1 <1
3 <1 <1 <1
10 <1 <1 <1
30 6.3 <1 <1
100 34.7 32.1 9.9
Details on test conditions:
Test vessels 100mL glass beakers, coverd with glass plates
Test volume 50mL
Illumination ~ 900 LUX, 16/8 hours light/dark rhythm
No. of test organisms 20 organisms per concentration in 2 groups of 10
Test duration 48 hours
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
0.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.75 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
2.95 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Results with reference substance (positive control):
The 24 hours EC50 of the reference substance potassium dichromate was 1.2 mg/L and thus within the target range of 0.9-1.9 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of Ro 1525 against Daphnia Magna was tested according to EU-Guideline 92/69/EWG of 1992. After 48 hours the effect concentration (EC50) reached 0.75 mg/l related to active substance based on nominal concentration.
Executive summary:

The acute toxicity of Ro 1525 against Daphnia Magna was tested according to EU-Guideline 92/69/EWG of 1992. After 48 hours the effect concentration (EC50) reached 0.75 mg/l related to active substance based on nominal concentration.