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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test substance: MGDN
Purity: 99.5 area-% by HPLC-fingerprint / 99.9 g/100 g by H-NMR spectroscopy

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were diluted in M4-medium.

Test solutions

Vehicle:
no
Details on test solutions:
The test concentrations were prepared by serial dilution of a stock solution of 100 mg/L.
All test batches were present as clear solutions over the exposure period according to visual inspection.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
- Test species / strain: Daphnia magna Straus
- Animal supplier: The clone of Daphnia magna STRAUS 1820 used in this study was originally obtained from the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory of Ecotoxicology of the Experimental Toxicology and Ecology of the BASF Aktiengesellschaft, Ludwigshafen, Germany.
- Age of the animals at the start of the exposure: 2 to < 24 h (starting with the 3rd breed of parent animals)
- Age of parent animals: 2 - 4 weeks

Study design

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

Test conditions

Hardness:
2.20 - 3.20 mmol/L
Test temperature:
18 - 22 °C
pH:
7.5 - 8.5
Nominal and measured concentrations:
Test concentrations (nominal): 0, 6.25, 12.5, 25, 50, and 100 mg/L
The recovery rates of the test substance in the test solutions during the exposure period were within the range of +20% of the nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass tubes with flat bottom
- Fill volume: 20 mL
- Test volume: 10 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 1
- No. of vessels for analytical control (without animals): 1
- Biomass loading rate: 0.5 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic fresh water (M4 medium) according to OECD 202
- Properties of this medium:
- Total hardness: 2.20 – 3.20 mmol/L
- Acid capacity up to pH 4.3: 0.80 – 1.00 mmol/L
- Molar ratio Ca:Mg: about 4 : 1
- pH value: 7.5 – 8.5
- Conductivity: 550 - 650 μS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: artificial light, type warm white (OSRAM L58 W31), about 1- 8 µE / (cm2xs) at a wave length of 400-750 nm


EFFECT PARAMETERS MEASURED:
- Swimming ability of the test animals

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
>= 100 mg/L
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Results of the validity criteria:
- In the control the immobilization was ≤ 10%.
- In the control no daphnids were be captured in a surface film.
- The O2-concentration was at least > 3 mg/L in all tested replicates.
- The EC50 of the control substance K2Cr2O7 after 24 hours ranged within 0.6 and 1.7 mg/L.
- The measured test concentrations were within ± 20% of nominal test concentrations.

Applicant's summary and conclusion