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:
From 2006, November the 21st to december the 1st
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No amendment to the study plan was requested. No incident, which could have affected the quality or the interpretation of the results obtained, was observed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2007-01-12

Test material

Constituent 1
Reference substance name:
Montanov 14
IUPAC Name:
Montanov 14
Details on test material:
- Name: Montanov 14
- Batch n°: T53815
- Appearence: pearls of was
- Purity: ES>99%
- Stability: water 96h
- Solubility: water<0.1g/L
- Expiration date: 22.09.07
- Storage: romm temperature 20 +/- 5°C

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
As the solubility lies below 100mg/L, the water-accomodated fraction was prepared for the test. this was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours; the resulting solution was filtrated through 0.45 um filters.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Variety STRAUS
Strain: Berlin
Sex: female
Age: between 0 end 24 hours
Origin: Umweltbundesamt Berlin
Arrival of Strain: October 4th 2005
Selection of the test system was made following the proposal of the guidelines.
Food: unicellular green algae, not during the test
Medium renewal: twice a week
Photo period: 16/8 hours, using neon tubes
T: 20 +/- 2°C

Study design

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

Test conditions

Hardness:
2.50 mmol/L
Test temperature:
21.4-22.4°C
pH:
from 7.4 to 8
Dissolved oxygen:
above 8.3 mg/L
Details on test conditions:
- Vessels: glass beakers, nominal volume 50 mL, tall shape
- Feeding: none
- lighting: none
-Temperature: 20 +/-2°C
Reference substance (positive control):
yes
Remarks:
K2Cr2O7

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
24h EC50 of K2Cr2O7 was determined at 1.4mg/L
Immobilisation in the controls was 10% at he most
The lowest concentration of dissolved oxygen at the end of the test was 8.3mg/L
The highest pH variation was 0.4 units.
The study can be considered valid
Results with reference substance (positive control):
24h EC50 of K2Cr2O7 was determined at 1.4mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
24h NOEC= 100mg/L
48h NOEC= 100mg/L
24h EC50i> 100mg/L
48h EC50> 100 mg/L
Executive summary:

This study was performed in order to evaluate the toxic potential of MONTANOV 14 towards freshwater shrimp, using species Daphnia magna. D magna STRAUSS, which belongs to the family of crustacea, was chosen in the guideline as a typical part of zoo-plancton.

As the solubility lies below 100mg/L, the water-accomodated fraction was prepared for the test. t his was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours; the resulting solution was filtrated through 0.45 um filters.

In the main study, 3 concentrations of the test item was used, spaces by factor 10, the highesty being 100 mg/L were used. 20 Daphnia were exposed to the test item for 48 hours, immobilised Daphnia were counted.

24h EC50 of K2Cr2O7 was determined at 1.4mg/L, lying with demanded range of 0.6 -2.1mg/L.

The following results were obtained for the test item:

24h NOEC= 100mg/L

48h NOEC= 100mg/L

24h EC50i> 100mg/L

48h EC50> 100 mg/L