Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the currently available guideline, according to GLP and the validity criteria are considered as fulfilled.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were taken and analysed after 0 and 48 hours

Test solutions

Vehicle:
no
Details on test solutions:
Due to the low water solubility of the test item, the water-accommodated fraction was perapared by filtration of a saturated solution after stirring for 24 hours. Then, the test solution was disolved with deionised water enriched with minerals according to the guidelines.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia Magna, Straus, Berlin
Sex: female
Age: between 0 and 24 hours
Source: supplied by Umweltbundesamt Berlin

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
250
Test temperature:
22.1 - 22.7°C
pH:
7.4 - 7.5
Dissolved oxygen:
7.9 - 8.4 mg/L
Salinity:
Not given.
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: 40 and 37 mg/L at 0 hours and 48 hours
38 mg/L is considered as the limit of water solubility of the product
Details on test conditions:
- Test vesells: 50 mL
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
38 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
38 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 38 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 38 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 38 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 38 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Details on results:
No significant effects up to the water solubility of the test substance (38 mg/L) was observed. Therefore, no EC50 could be deteremined.
Results with reference substance (positive control):
The 24h-EC50 to potassium dichromate was determine dto be 0.98 mg/L and is thus in the demanded range of 0.6 - 2.1 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No significant effects to Daphnia magna up to the water solubility of the test substance (38 mg/L) was observed. The NOEC after 24 und 48 hours was determined to be 38 mg/L. The 24h and 48 h EC50 is clearly above the maximum tested concentration of 38 mg/L.
Executive summary:

The acute immobilization of the test item Zorgol 8 to Daphnia magna (STRAUS) was determined according to OECD 202 (2004). 20 test organisms were exposed for up to 48 hours in a static test system to the limit dose of 100 mg/L nominal. At start and end of the test the test subatnce concentration was determined based on DOC measurements. The measured concentrations were 40% and 37% of the nominal value at the start and after 48 hours of the test resulting in a geometric mean concentration of 38 mg/L. This value is considered as the water solubility of the test subatnce. Therefore, the determination of the biolagical results are based on the mean of the measured concentrations.

No significant effects to Daphnia magna up to the water solubility of the test substance (38 mg/L) was observed. The NOEC after 24 und 48 hours was determined to be 38 mg/L. The 24h and 48 h EC50 is clearly above the maximum tested concentration of 38 mg/L.