2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol

Short-term toxicity to aquatic invertebrates

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:

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:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: - no data
- Sample storage conditions before analysis: not applicable

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- no difficulties encountered (0.5 mg test substance/mL; dissolved in ultra-pure water)

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus
- Justification for species other than prescribed by test guideline: -
- Source: Laboratory of Hydrobiology, 2100 Gödöllö, Kotlan S. u. 3, Hungary
- Age of parental stock (mean and range, SD): not available
- Feeding during test: no
- Food type: not applicable
- Amount: not applicable
- Frequency: not applicable

ACCLIMATION
- Acclimation period: at least 48h
- Acclimation conditions (same as test or not): similar or same
- Type and amount of food: concentrated algal suspension
- Feeding frequency: not available
- Health during acclimation (any mortality observed): not available

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

none

Post exposure observation period:

no

Hardness:

249 mg/L (as CaCO3)

Test temperature:

20.1 - 20.2 °C

pH:

7.90- 8.07

Dissolved oxygen:

7.96 - 8.07 mg/L

Salinity:

no information available

Conductivity:

no information available

Nominal and measured concentrations:

The study was conducted as a limit test with the concentration of 100 mg/L. The concentrations reported as nominal as recovery was 99% (start) and 102% (end).

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL glass beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: fill volume: 40 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: not available

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (ISO medium acc. to OECD TG 202)

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16/8 (light/dark)
- Light intensity: not available

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

VEHICLE CONTROL PERFORMED: not applicable

RANGE-FINDING STUDY
- Test concentrations: 0.01 - 100 mg/L
- Results used to determine the conditions for the definitive study: no immobilisation observed at any concentration

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (non-concurrent, but tested on 20-21.09.2016)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none reported
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid?
- Relevant effect levels: 24h EC50:1.57 mg/L (performed on 20.-21.09.16)
- Limit test: no
- Dose-response test: yes

In a GLP-study according to OECD test guideline 202 the substance did show no toxicity to daphnia magna at the limit test concentration of 100 mg/L under static conditions. Therefore, it has a NOEC of 100 mg/L and an EC50 of >100 mg/L.

Validity criteria fulfilled:

yes

Executive summary:

The acute toxicity of the substance was investigated in a GLP-study according to OECD test guideline 202 using Daphnia magna.

The study was performed using one concentration containing 100 mg/L with a treatment period of 48 hours under static conditions. The immobilisation of Daphnia was observed at 24h and 48h.

At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC-UV. The recovery after 48 hours was 102 % of the start concentration. Therefore, the determination of the results was based on the nominal concentrations.

The EC50 of the positive reference control potassium dichromate were tested in a non-current reference test. The values lay within the normal range of the laboratory.

As the substance caused no toxicity, a NOEC of 100 mg/L and an EC50 of >100 mg/L were determined.

Description of key information

In a GLP-study according to OECD test guideline 202 (static) the substance did show no toxicity to daphnia magna at the limit test concentration of 100 mg/L. Therefore, it has a NOEC of 100 mg/L and an EC50 of >100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L