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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
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: Study conducted to internationally accepted guidelines and to GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: WAF
- Eluate:
- Differential loading:
- Controls:
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):
- Concentration of vehicle in test medium (stock solution and final test solution):
- Evidence of undissolved material (e.g. precipitate, surface film, etc):
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia Magna
- Strain: Straus
- Source: Cultured in-house
- Age at study initiation (mean and range, SD): Less than 24 hours old
- Weight at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD):
- Valve height at study initiation, for shell deposition study (mean and range, SD):
- Peripheral shell growth removed prior to test initiation:
- Method of breeding:
- Feeding during test
- Food type:
- Amount: None
- Frequency:

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
Total hardness of the Elendt M4 medium was 250 mg/L as CaCo3.
Test temperature:
Temperature was in the range 21.0 to 21.4 measured at the start and end of the study.
pH:
pH was in the range 7.6 to 7.9 measured at the start and end of the study.
Dissolved oxygen:
Dissolved oxygen was in the range 76 to 100% measured at the start and end of the study.
Nominal and measured concentrations:
Nominal loading rates: 0.1, 0.32, 1.0, 3.2 and 10 mg/L as WAF
Mean measured TOC levels (3 highest levels ): 0.85, 1.38 and 4.44 mgC/L
Details on test conditions:
TEST SYSTEM
- Test vessel: sealed glass Wheaton vial
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: No headspace using volume of approx 120 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): Static
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 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:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 h light : 8 h dark
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: 1, 10, 100 and 1000 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
5.66 mg/L
Remarks on result:
other: 95% CL 3.2 - 10 mg/L
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
3.2 mg/L
Details on results:
After 48 hours, the lowest nominal loading rate at which 100% immobility occurred was
10 mg/L and the highest nominal loading rate at which no immobilisation was noted was
3.2 mg/L.
Validity criteria fulfilled:
not specified
Conclusions:
The 48-hour EL50 of Softanol 30 the immobilisation of Daphnia magna was 5.66 mg/L (95%
confidence limits of 3.2 and 10 mg/L) and the ‘no-observed effect loading rate’ of Softanol
30 with Daphnia magna was 3.2 mg/L.

Description of key information

One study is available and valid.
The 48–h-acute toxicity of Softanol 30 to Daphnia magna was studied under static conditions (Huntingdon Life Sciences Ltd, 2010 report PLZ0025).  Daphnids were exposed for 48 hours to WAFs of Softanol 30, prepared from aqueous mixtures with initial nominal concentrations (loading rates) of 0.1, 0.32, 1.0, 3.2 and 10 mg/L. Mortality/immobilization and sublethal effects were observed after approximately 24 and 48 hours. The 24 and 48 hour EL50 was 5.66 mg/L and the no observed effect loading rate (NOELR) was 3.2 mg/L
This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
5.66 mg/L

Additional information