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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:
09. May - 26. Sept. 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name TREHALOSE, ANHYDROUS
Batch no. 160805
Appearance White crystalline powder
Composition Trehalose: 100 % (dry basis)
The test item was stored in a closed vessel, dark and dry at room temperature 20 ± 5°C.
Analytical monitoring:
yes
Details on sampling:
no specific sampling. Dilution Factor 2.5
Vehicle:
no
Details on test solutions:
A solution containing 100.4 mg/L test item in dilution water was prepared and used for the
test
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Berlin
- Justification for species other than prescribed by test guideline:
- Source: Umweltbundesamt Berlin
- Age of parental stock (mean and range, SD): In house breeding since 27. September 2007
- Age of animals for test: between 0 and 24 hours
- Feeding during test none

ACCLIMATION
- Acclimation period: not applicable
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Remarks on exposure duration:
according to Guideline
Post exposure observation period:
no
Hardness:
250 mg CaCO3 / L
Test temperature:
20.3 - 21.8 °C
pH:
7.8
Dissolved oxygen:
8.7-8.8 mg/L
Salinity:
not applicable
Conductivity:
not stated
Nominal and measured concentrations:
nominal: 100 mg/L
Measured at t = 0h: 93.9 mg/L
Measured at t = 48 h = 98.1 mg/L
Details on test conditions:
Date of performance 12. Jun. - 14. Jun. 2018
Treatments 100 mg/L (nominal)
The concentrations to be tested are based on the result of
a non-GLP pre-test.
Temperature 20.3 - 21.8 °C
Duration 48 hours
Observation times 24 and 48 hours
Medium renewal none
Test vessels glass beakers, nominal volume 50 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 20 ± 5 mL test solution and 5
Daphnia
Replicates (Blank control) 4 vessels, each containing 20 ± 5 mL dilution water and 5
Daphnia
Reference substance (positive control):
yes
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No observations were made which might cause doubts concerning the validity of the study
outcome. All validity criteria were met.
Results with reference substance (positive control):
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a
current reference study (201714R201). The 24h-EC50i value was determined as 1.9 mg/L.
The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium
dichromate K2Cr2O7 as specified in the OECD guideline. Since the fits showed
sufficient statistical correspondence of the data with the dose-response-equation, this reference
study can be considered valid.
Reported statistics and error estimates:
no statistics reported
Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, Trehalose did not show any effects on Daphnia magna and following toxicological dose discriptor is derived:
48h-NOEC ≥ 100 mg/L
Executive summary:

One valid experiment was performed.

The study was performed as a limit test using a concentration at 100 mg/L. For the test

concentration and the blank control, 20 Daphnia were exposed to the test item for 48

hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

No toxicity was observed and none of the animals was immobilised in the blank control.

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a

current reference study to assure that the test conditions are reliable.

At the beginning and at the end of the test, the content of the test item in the test solutions

was determined using HPLC-MS-determination. The concentrations determined at the

start of the test were 94% of the nominal concentration. At the end of the test the determined

concentrations were 98% of the nominal concentration. Therefore, the determination

of the biological results was based on the nominal concentration.

The following results were determined for the test item TREHALOSE, ANHYDROUS (species:

Daphnia magna).

48h-NOEC ≥ 100 mg/L

48h-LOEC > 100 mg/L

24h-EC50 > 100 mg/L

48h-EC50 > 100 mg/L

Description of key information

one study on toxicity against Daphnia Magna available.

No effects of the substance were observed hence no LC50 value is given.

Key value for chemical safety assessment

Additional information