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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:
Experimental dates: 13 to 16 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplied by Sponsor, batch ref: 171116
- Expiration date of the lot/batch: 16/11/2019
- Purity test date: 16/11/2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temp, in the dark
- Stability under test conditions: No data

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations:
Nominal test concentrations: Control and 10, 18, 32, 56 and 100% of a saturated solution prepared at 100 mg/L
- Sampling method:
0h: 2.0 mL from centre of test vessels
48h: 2.0 mL from pooled replicates
- Sample storage conditions before analysis: Samples were stored frozen

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance added to dilution medium and stirred for 3 days with magnetic stirrer in the dark. Saturated solution collected by filtration (0.45 um membrance filter). Lower test concentrations prepared by dilution of 100% saturated solution
- Eluate: Test medium
- Differential loading: No
- Controls: Diltuion medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- All test solutions observed to be clear and colourless at the end of preparation procedure

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magma
- Strain/clone: Staus, 1820
- Source: Laboratory culture
- Age of parental stock (mean and range, SD): <2 weeks
- Feeding during test: No
- Food type: n/a
- Amount: n/a
- Frequency: n/a

ACCLIMATION
- Acclimation period: None

Study design

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

Test conditions

Hardness:
No data
Test temperature:
20-21oC
pH:
0h: 7.9 - 8.0
48h: 8.0
Dissolved oxygen:
0h: 8.5 - 8.6
48h: 8.7 - 8.8
Salinity:
No data
Conductivity:
No data
Nominal and measured concentrations:
Nominal concentrations: 10, 18, 32, 56 and 100% of a saturated solution prepared at 100 mg/L
Measured concentrations: 100% SS = 0.12 mg/L (89% of initial measured concn)
Details on test conditions:
TEST SYSTEM
- Test vessel: 60 mL glass beakers
- Material, size, headspace, fill volume: Glass beakers, 50 mL fill volume
- Aeration: No
- 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:

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16h
- Light intensity: No data

RANGE-FINDING STUDY
- Test concentrations: Control, 1.0, 10 and 100% SS at 100 mg/L
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.12 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

Nominal concn

(% of SS at 100 mg/L)

No. Daphnia immobile

0h

24h

48h

Control

0

0

0

10

0

0

0

18

0

0

0

32

0

0

0

56

0

0

0

100

0

0

1

Total no. Daphnia per test concentration was 20

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48h EC50 for Daphnia magna was considered to exceed the limit of solubility of the test substance in test medium. No significant immobility was observed in the control or at any of the test concentrations throughout the exposure period.
Executive summary:

In a 48-hr acute toxicity study the aquatic invertebrate, Daphnia magna, was exposed to a range of test concentrations under static conditions in accordance with the OECD test guideline 202 and in compliance with GLP.  The nominal test concentrations were a control and 10, 18, 32, 56 and 100% v/v saturated solution prepared at a nominal loading rate of 100 mg/l. The measured concentrations at 0 and 48-hour were 0.122 and 0.108 mg/l, respectively. Under the conditions of the test, the EC50 (immobility) was determined to exceed the limit of solubility of the test substance in medium. The EC50 was reported byt he testing laboratory to be > 0.12 mg/l based on initial measured concentrations (or >100 mg/l nominal loading rate). No significant immobility was observed in the control or at any of the test concentrations throughout the exposure period at the limit of solubility. This acute toxicity study is reliable and satisfies the guideline requirements for a short-term toxicity study to aquatic invertebrates.