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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 to 14 June 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted under the appropriate guideline following GLP methodology.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not applicable
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L (Limit Test) based on preliminary range-finding results
Vehicle:
no
Details on test solutions:
Test concentration were prepared by addition of the required amount of n-Butyl-3-hydroxybutyrate directly to the dilution water to give the required concentration of 100 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: Smithers Viscient
- Age at study initiation (mean and range, SD): less than 24 hours
- Feeding during test: no
- Food type: suspension of Chlorella vulgaris
- Amount: 1 mg organic carbon/L of culture water and YCT
- Frequency: every other working day

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
20.4 to 21.6°C
pH:
7.38 to 8.02
Dissolved oxygen:
5.99 to 7.78
Salinity:
not applicable
Nominal and measured concentrations:
range finding nonmial concentrations were 0.1, 1.0, 10, and 100 mg/L; definitive nominal concentration was 100 mg/L reported as 95.8 mg/L measured or 96.3%.
Details on test conditions:
TEST SYSTEM
- Test vessel: plastic
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 25 ml
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): 24 hour renewal
- 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: Elendt M4 media:
- Range finding study yes
- Test concentrations: 0.1, 1.0, 10, 100
- Results used to determine the conditions for the definitive study: yes
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
not specified
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: 5 daphnids in 100 mg/L were trapped in the meniscus at 24 hours with 1 daphnid moving slowly. At 48 hours, 6 organsims were trapped in the meniscus and 1 was moving slowly.

- Mortality of control: none
- Other adverse effects control: 2 organisms were trapped in the meniscus at 24 hours with no signs of abnormal behaviour at 48 hours
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
none
Validity criteria fulfilled:
yes
Conclusions:
The study was conducted as a Limit Test based upon preliminary range-finding results with no reported mortaliy in the 100 mg/L concentration. The study followed OECD 202 and GLP and was therefore deemed valid and reliable. The 48-hr EC50 value was > 100 mg/L (nominal).
Executive summary:

A study was conducted to determine the the acute toxicity of n-Butyl-2 -hydroxybutyrate to the cladoceran, Daphnia magna in a 48 hour exposure following OECD 202. Analytical measurement of the exposure solutions showed mean measured concentrations that were 80 to 120% of nominal therefore all concentrations are reported as nominal concentrations. A preliminary range-finding study with concentrations of 0.1, 1.0, 10 and 100 mg/L had no mortality reported after 48 hours of exposure, so a limit test at 100 mg/L was conducted following guideline recommendations. The 48-hr EC50 value was estimated to be >100 mg/L. The highest no observed effect concentration (NOEC) for both mortality and visible sub-lethal effects after 96 hours was 100 mg/L.

Description of key information

The study was conducted as a Limit Test based upon preliminary range-finding results with no reported mortaliy in the 100 mg/L concentration.  The study followed OECD 202 and GLP and was therefore deemed valid and reliable.  The 48-hr EC50 value was > 100 mg/L (nominal).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information