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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
study was performed as limit test combined with a range-finder test
GLP compliance:
Analytical monitoring:
Details on sampling:
- Concentrations: samples taken from control and highest test concentration at start and end of exposure period
- Sampling method: at end of exposure period replicates were pooled before sampling of 3 ml solution
- Sample storage conditions before analysis: in the freezer (stability under conditions was determined in previous project)
Details on test solutions:
Preparation of test solution started with the highest test concentration of nominal 400 mg/L. This concentration corresponded to 100 mg a.i./L. No special treatment other than a short period of magnetic stirring (15 minutes) was applied to ensure complete dissolution in the test medium. The pH of this solution was above 9.4 and as a consequence adjusted to 7.8 using 1M HCl (Merck, Darmstadt, Germany). The lower test concentrations were prepared by subsequent dilutions in test medium. The final test solutions were all clear and colourless.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Common name: Daphnia magna
- Strain: Straus, 1820
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): less than 24 hours
- Method of breeding:
- Feeding during test
- Food type: no feeding
- Amount: no feedng
- Frequency: no feeding

- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):
Test type:
Water media type:
Limit test:
Total exposure duration:
Test temperature:
start: 20.4 °C
variation during test period: 18.4 - 20.2 °C
control: pH 7.9 at start and end of test period
100 mg a.i./L: pH 7.8 at start and pH 7.9 at end of test period
Dissolved oxygen:
9.3-9.4 mg O2/L at start and end of test period for both control and 100 mg a.i./L
Nominal and measured concentrations:
nominal: 0.1, 1.0, 10, and 100 mg a.i./L (corrected for purity)
measured: [100 mg a.i./L] (t=0) 97.7 mg a.i./L; (t=48 h) 97.0 mg a.i./L
Details on test conditions:
- Test vessel: 100 mL all-glass
- Material, size, headspace, fill volume: 80 mL solution
- Aeration: no aeration of test solutions

- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2 replicates for 0.1, 1.0 and 10 mg a.i./L; 4 replicates for 100 mg a.i./L
- No. of vessels per control (replicates): 4

- Source/preparation of dilution water: adjusted ISO medium
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

- Adjustment of pH:
- Photoperiod: 16 hours daily
- Light intensity: no information available

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility after 24h and 48h

- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
potassium dichromate
48 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
Conc. based on:
act. ingr.
Basis for effect:
Details on results:
test substance showed no toxic effects at highest test concentration
Results with reference substance (positive control):
EC50(48h)= 0.42 mg/L (95% c.i. 0.32 - 0.56 mg/L)
Reported statistics and error estimates:
no statistics reported due to lack of observed effects at test concentrations
Validity criteria fulfilled:
Under the conditions of the presented study the test substance did not induce acute immobilisation of Daphnia magna at 100 mg a.i./L after 48 hours of exposure (NOEC). The 48h-EC50 exceeded 100 mg a.i./L (corrected for purity and based on analytically confirmed nominal concentrations).
Executive summary:

The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, the procedures were designed to meet the test methods of the EEC directive 92/69, Part C.2, 1992 and the ISO International Standard 6341, 1996.

The batch of HAPS tested was a light yellow liquid consisting of 25.0 % HAPS (active ingredient; a.i.), 72.75 % water and 2..25 % sodium hydroxide. HAPS was completely soluble in test medium at the concentration tested. All concentrations reported were corrected for the purity of the test substance (25 %).

A limit test was combined with a range-finding test. Twenty daphnia per test group (4 replicates, 5 per vessel) were exposed to a control and a HAPS concentration of 100 mg/L in the limit test. In the combined range-finding test test daphnia (2 replicates, 5 per vessel) were exposed to HAPS concentrations of 0.1, 1.0, and 10 mg a.i./L. The total test peroid was 48 hours and a static test system was applied. Samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test period.

Analysis of the samples taken at the start and the end of the limit test showed that measured concentrations were in agreement with nominal (97 -98 %).

The study met the acceptability criteria prescribed by the protocol and was considered valid.

HAPS did not induce acute immobilisation of Daphnia magna at 100 mg a.i../L after 48 hours of exposure (NOEC). The 48h-EC50 exceeded 100 mg a.i./L (corrected for purity and based on analytically confirmed nominal concentrations).

Description of key information

In absence of visible effects in the study with Daphnia magna key value for the further assessment is set to 100 mg/L. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information