Betaine

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:

Study initiation date: March 23rd, 2010. Experimental starting date: March 30th, 2010. Experimental completion date: April 1st, 2010. Study completion date: April 12th, 2010.

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)

Deviations:

no

GLP compliance:

yes

Remarks:

SNAS reg. No. 049/G-020

Analytical monitoring:

yes

Test organisms (species):

Daphnia magna

Details on test organisms:

Source: National Reference Centre for Ecotoxicology, within the Public Health Authority of the Slovak Republic. Cultivated in the laboratory from March 13th, 2007 in stood tap water replaced regularly. Cultivation is carried out in the air-conditioned chamber, where constant temperature (20+/- 1C), light intensity (cca 700 lux) and light regime (light/dark 16h/8h) will be maintained. Detailed information is provided in the attached full study report.

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Remarks on exposure duration:

In addition to total exposure duration, the effective inhibition concentrations were calculated also for exposure time 24 hours .

Hardness:

140-150 mg/l (expressed as CaCO3)

Test temperature:

Average temperature in the air-conditioned chamber during the test was 20.4. C. Temperature was measured in each control and test solutions at 0 hour and after 48 hours. The initial temperatures in control and test solutions were 20.6 C, and after 48 hours 20.3 C.

pH:

pH of the test media was 7,8 +/- 0.2.The pH was measured in each control and test solutions at 0 hour and after 48 hours. The initial pH of the control was 7.65 and after 48 hours 7.22. The initial pH of the test solutions varied between 7.53 - 7.62, and after 48 hours between 7.25 - 7.29.

Dissolved oxygen:

Concentration of dissolved oxygen in test media was > 7.0 mg/l (> 90 % as balance concentration; oxygen saturation). The dissolved oxygen was measured in each control and test solutions at 0 hour and after 48 hours. The initial O2% of the control was 91.6 % and after 48 hours 90.7 %. In the test solutions, the initial O2- % varied between 90.9-91.8 %, and after 48 hours between 89.1-88.8 %.

Nominal and measured concentrations:

The definitive test was performed with these nominal concentrations of the test substance:
1300 mg/l, 1950 mg/l, 2925 mg/l, 4388 mg/l, 6581 mg/l. Before testing, the stability test for the test substance was assessed. According to the preliminary test results, the test substance was stable in water in the test media during 48 hours, because the TOC concentration after 48 hours was 92.4 % of the initial TOC concentration. The results of the initial concentration remained within 80-120 % of the nominal concentration after 48 hours. Therefore, renewal of the test solutions was not necessary to be carried out during D.magna test.

Details on test conditions:

The test was carried out in glass vessels with a total volume of 25 ml, each containing 10 ml of control or test solution. Four replicates of control vessels and test vessels for each concentration were used. Five animals less than 24 hours old were transferred to control and test vessels with fine nylon net. The vessels were covered with glass plate. The immobility of the daphnids were determined visually after 24 and 48 hours of exposure. Those organisms not able to swim within 15 seconds were considered to be immobile.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate. Source: Merck. Batch: K37874264.

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

2 870 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % confidence interval: 2117-3352 mg/l

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4 335 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % confidence interval: 3893-4887 mg/l

Duration:

24 h

Dose descriptor:

EC10

Effect conc.:

4 341 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % confidence interval: n.d.-5459 mg/l

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

5 805 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % confidence interval: 4077-9752 mg/l

Details on results:

Lowest concentration used in the test when 100 % immobilization of Daphnids was detected
After 24 hours >6581 mg/l
After 48 hours 6581 mg/l
The highest concentration used in the test when 0 % immobilization of Daphnids was detected
After 24 hours 4388 mg/l
After 48 hours 1300 mg/l

Results with reference substance (positive control):

The 24 hours EC50-value of Potassium dichromate was 1.10 mg/l which is within range specified in ISO 6341 (0.6-2.1 mg/l)

Reported statistics and error estimates:

95 % confidence limits were calculated and reported with the endpoint results

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test substance (tradename BETAFIN BP 20 ) to Daphnia magna was determined by using the OECD guideline method 202. The EC10- and EC50-values after 24 and 48 hours exposure were determined. The EC50-value after 24 hours exposure was 5805 mg/l with 95 % confidence interval of 4077-9752 mg/l. The EC50-value after 48 hours exposure was 4335 mg/l with 95 % confidence interval of 3893-4887 mg/l. In accordance with the test results the substance possesses low acute toxicity to D.magna.

Executive summary:

The acute toxicity of the test substance (tradename BETAFIN BP 20) to Daphnia magna was determined by using the OECD guideline method 202. The EC₁₀- and EC₅₀-values after 24 and 48 hours exposure were determined. The EC₅₀-value after 24 hours exposure was 5805 mg/L with 95 % confidence interval of 4077-9752 mg/l. The EC₅₀-value after 48 hours exposure was 4335 mg/L with 95 % confidence interval of 3893-4887 mg/L. In accordance with the test results the substance possesses low acute toxicity to D. magna.

Description of key information

The study was carried out according to OECD guideline method 202. Daphnia magna immobilisation was determined as EC10- and EC50-values for 24 h and 48 h exposure. The study was conducted in accordance with Principles of Good Laboratory Practice. The EC50-value after 24 hours exposure was 5805 mg/L with 95 % confidence interval of 4077-9752 mg/L. The EC50-value after 48 hours exposure was 4335 mg/L with 95 % confidence interval of 3893-4887 mg/L. This substance possesses low acute aquatic toxicity in freshwater.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

4 335 mg/L

Additional information

The acute toxicity of the test substance (trade name BETAFIN BP 20) to Daphnia magna was determined by using the OECD guideline method 202. The EC10- and EC50-values after 24 and 48 hours exposure were determined. The EC50-value after 24 hours exposure was 5805 mg/L with 95 % confidence interval of 4077-9752 mg/L. The EC50-value after 48 hours exposure was 4335 mg/L with 95 % confidence interval of 3893-4887 mg/L. In accordance with the test results the substance possesses low acute toxicity to D. magna. The aquatic toxicity test result (48 h) to D. magna does not indicate the need for this substance to be classified as hazardous to the aquatic environment.