Reaction mass of hentriacontan-16-one and pentatriacontan-18-one and tritriacontan-16-one

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

Study period:

From 2018-01-23 to 2018-01-25

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)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Batch No.: FK650468
Purity: 100%

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

- Formulation: A saturated test item solution (nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the study. This solution was shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 μm) filter to give the 100 % saturated solution

Test organisms (species):

Daphnia magna

Details on test organisms:

- Source: István Szent University
- Breeding: The Daphnia are bred in lab. The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
- Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
- Number of animals: There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate)
- Age of the animals: They were less than 24 h old at the beginning of the test
- Acclimatization: There was no acclimatization because the water used was similar to the culture water.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

247 mg/L (as CaCO3).

Test temperature:

19.9 – 20.8°C

pH:

7.03 – 7.55

Dissolved oxygen:

7.6 – 8.9 mg/L

Nominal and measured concentrations:

-Nominal: 100% saturated solution

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker with a volume of 50 mL
- Material, size, headspace, fill volume: ~40 mL test solution/flask; 8 mL test solution/animal
- Renewal rate of test solution (frequency/flow rate): 24 h
- 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: Reconstituted water (ISO medium, according to OECD 202)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light and 8-hour dark cycle

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
The number of immobilised animals and the percentage of immobility were determined at 24 and 48 hours.
The water temperature was measured daily, the oxygen concentrations and pH of the control and the test solution were measured at the beginning and at the end of the experiment.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 0.1%, 1%, 10%, 100% saturated solution
- Results used to determine the conditions for the definitive study: no toxic response was observed

Reference substance (positive control):

yes

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 other: % saturated solution

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 other: % saturated solution

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Immobilisation: No immobilised animals were observed at the 24th and 48th hour. No abnormal behaviour or appearance of test animals was detected.

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- The 24h EC50 of Potassium dichromate: 0.65 mg/L, (95 % confidence limits: 0.61 – 0.70 mg/L)

Validity criteria fulfilled:

yes

Conclusions:

The test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.

Executive summary:

Acute toxicity of test item on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system based on OECD 202.

Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration at the solubility level of the test item in the test medium (100 % saturated solution) and one control group in the definitive test.

The biological results are based on the nominal test concentration.

Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.

All validity criteria were met during this study.

Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of test item were the followings:

The 24h and 48h EC50 value: > 100% saturated solution (nominal)

The 48h EC100 value: > 100% saturated solution (nominal)

The 48h No-Observed Effect Concentration (NOEC): 100% saturated solution (nominal)

The 48h Lowest Observed Effect Concentration (LOEC): > 100% saturated solution (nominal)

Based on the results of this study, the test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.

Description of key information

The test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.

Additional information

Acute toxicity of test item on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system based on OECD 202.

Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration at the solubility level of the test item in the test medium (100 % saturated solution) and one control group in the definitive test.

The biological results are based on the nominal test concentration.

Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.

All validity criteria were met during this study.

Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of test item were the followings:

The 24h and 48h EC50 value: > 100% saturated solution (nominal)

The 48h EC100 value: > 100% saturated solution (nominal)

The 48h No-Observed Effect Concentration (NOEC): 100% saturated solution (nominal)

The 48h Lowest Observed Effect Concentration (LOEC): > 100% saturated solution (nominal)

Based on the results of this study, the test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.