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:
Range finding test was conducted between 2005-08-30 and 2005-09-01. Definitive test was conducted between 2005-09-20 and 2005-09-22. Report signed off 2005-11-25.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the control and the 100 mg ai/L test groups at 0 and 48h for quantitative analysis. Duplicate samples were taken and stored at approx. -20 degree C for further analysis if necessary.

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: in house laboratory cultures at SafePharm Laboratories
- Age at study initiation (mean and range, SD): <24h
- Method of breeding: parthenogenesis
- Feeding during test: none

Study design

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

Test conditions

Hardness:
CA 250 mg CaCO3/L
Test temperature:
21.2 - 21.8 degree C
pH:
7.9 - 8.0
Dissolved oxygen:
102 % (ASV)
Nominal and measured concentrations:
Analytical information indicated that the material is 85.6% pure therefore all test concentrations were corrected for this. In the range finding test Daphnia were exposed to a series of nominal concentrations of 0.10, 1.0, 10 and 100 mg ai/l. Based on the rangefinding test a limit test was conducted at a concentration of 100 mg ai/l.

Analysis of the test preparations at 0 and 48h showed measured test concentrations ranging from 105% to 111% of nominal value, therefore, the results are based on nominal test concentrations only.
Details on test conditions:
TEST SYSTEM
- Test vessel: 250ml glass jars
- Type : covered
- Fill volume: 200ml
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water produced in house from deionised water
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16h light and 8h dark with 20 min. dawn/dusk transition

EFFECT PARAMETERS MEASURED: Immobilisation at 24 and 48h

TEST CONCENTRATIONS
- Range finding study: 0.10, 1.0, 10.0 and 100 mg ai/l
- Test concentrations: 100 mg ai/l
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
The control was observed to be a clear colourless solution and the 100 mg ai/l test concentration was observed to be a black coloured solution. Due to the dark colouration of the 100 mg ai/l test concentration, daphnids were placed in fresh reconstituted water for the period of observations.

There was no immobilisation in 20 daphnids exposed to a test concentration of 100 mg ai/l of test substance for a period of 48h.
Results with reference substance (positive control):
A positive control is conducted by the test house approximately every 6 months using potassium dichromate. The results from the positive control were within the normal range for this reference material. The mean 48h EC50 value calculated from this positive controls was 1.1 mg/l (95% CL 0.97 - 1.2).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
It is concluded that as none of the Daphnia magna were observed as immobilised after 24 and 48h in the control or test concentration solutions and no other symptoms of toxicity were observed that the test substance has no effect on Daphnia magna at 100 mg ai/l (based on nominal concentrations).
Executive summary:

Introduction

The study was performed to assess the acute toxicity of the test substance to Daphnia magna. The method was designed to be compatible with the following guidelines:

OECD Guidelines for the testing of Chemicals (2004). Test guideline 202 Part I, Daphnia sp. Acute Immobilisation Test.

Method C.2 of Commission Directive 92/69/EEC.

Results

After 48h no immobilisation was observed in the test substance test vessels or in the dilution water.

Conclusions

The 24 and 48h EC50 was determined to be >100 mg ai/l of test substance. The 48h NOEC was 100 mg ai/l. It is concluded that as none of the Daphnia magna were observed as immobilised after 24 and 48h in the control or test concentration solutions and no other symptoms of toxicity were observed that the test substance has no effect on Daphnia magna at 100 mg ai/l (based on nominal concentrations).