1-Propanesulfonic acid, 3-(cyclohexylamino)-2-hydroxy-, sodium salt (1:1)

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 2012-11-23 to 2013-05-23

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 (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: At the start of the experiment one sample was taken from the control and eight parallel samples were taken from the test solution, while at the end of the study one sample was taken from the control and two parallel samples were taken from each of the four replicates of the 100 mg/L test item group.
- Sample storage conditions before analysis: at room temperature

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion. 0.1055 g of test item was dissolved in 1000 mL of the dilution water (Elendt M4 medium) in order to give the concentration of 100 mg/L.
- Controls:
Blank control performed with the test solution without test substance
Positive control: performed with the reference substance: potassium dichromate
- Evidence of undissolved material: no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Daphnia magna (Straus)
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. (Hungary)
- Age at study initiation: < 24 h
- Method of breeding: The Daphnia are bred in the Laboratory of TOXI-COOP ZRT.
- Feeding during test: no

ACCLIMATION
- Acclimation period: Test animals were bred under similar conditions as that used during the exposure period, therefore additional acclimatisation before the test was not necessary.
- Acclimation conditions: same as the test (see above)
- Type and amount of food: concentrated algal suspension of Pseudokirchneriella subcapitata during holding

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Hardness:

The reconstituted water (Elendt M4 Medium) had a total hardness of 225.526 mg/L (as CaCO3).

Test temperature:

20.2 – 20.3 °C

pH:

7.59 – 7.68 in the control group and 9.15 – 9.41 in the test item treated group

Dissolved oxygen:

7.16 – 7.98 mg/L

Nominal and measured concentrations:

Nominal concentration: 0 (control), 100 mg/L
Measured concentrations:
Start of the test: 96, 98, 117, and 118 mg/L
End of the test: 110, 111, 112 and 113 mg/L
Measured test item concentrations were 96 - 118 % of the nominal at the start and 110-113 % of the nominal at the end of the test

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker
- Volume: 50 mL
- 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: Reconstituted water (Elendt M4 medium, according to OECD 202)
- Culture medium different from test medium: no
- Intervals of water quality measurement: The water temperature, dissolved oxygen concentration and pH were measured in each test concentration and control at the start and in each test vessel at the end of the test. Additionally, the ambient temperature was measured continuously using a min/max thermometer in the climate chamber.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light (artificial illumination at an intensity of approximately 979 lux) and 8 hours darkness.
- Light intensity: approximately 979 lux

EFFECT PARAMETERS MEASURED
Immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test due to results of a range finding test
- Range finding study: yes
- Test concentrations: 0.01, 0.1, 1, 10, 50 and 100 mg test item/L
- Results used to determine the conditions for the definitive study: No immobility or any sub-lethal effects were detected in the treatment group or in the control group during the 48-h exposure period.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

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

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no
- Any observations that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no effects observed
The EC50 (48h) of the test item to Daphnia magna was determined to be greater than 100 mg/L based on nominal concentration and the NOEC (48h) was determined to be >= 100 mg/L

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50/LC50: 24h EC50: 1.03 mg/L, (95 % confidence limits: 0.82 – 1.29 mg/L)
Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.

Reported statistics and error estimates:

not applicable (as no effects observed)

Immobilization of the test animals

Nominal Concentration [mg/L]	Replicate	Number of treated animals	Number of immobilised animals
			24 h	48 h
Control	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
100.0	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0

Validity criteria fulfilled:

yes

Conclusions:

The EC50 (48 h) of the test item to Daphnia magna was determined to be greater than 100 mg/L according to OECD 202 (2004) in a static test system under GLP conditions. The results are based on the nominal concentration.

Executive summary:

The EC50 (48h) of the test item to Daphnia magna was determined according to OECD 202 (2004) in a static test system under GLP conditions. Young Daphnia were exposed to aqueous test media containing the test item for 48 hours under defined conditions. Based on the results of the preliminary test (static test), the test item has no toxic effect on the daphnids up a concentration of 100 mg/L. Therefore, the main test was performed at a concentration level of 100 mg/L and a concurrent control. A static test was performed because the test item was stable in test water during the test period of 48 hours. The test item concentration of the test solutions was measured by LC/MS method at the start and end of the test. As the performed analytical determinations confirmed that the test item concentration remained within the range of ± 20 % of the nominal concentration, the biological results are reported based on the nominal concentration of the test item. Twenty Daphnia (divided into four replicates) were tested at the test concentration and in the untreated control. Each test vessel contained approximately 40 mL test medium. The test medium (dilution water) was the Elendt M4 Medium according to OECD guideline. Temperature and pH were measured with the suitable instruments at the start and at the end of the test. All of the measured values remained in the acceptable ranges. For the evaluation of the quality of the Daphnia clone and the experimental conditions, potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions. The 24h EC50 of the reference substance is determined to be 1.03 mg/L. The immobilisation of the test animals was recorded 24 and 48 hours after treatment. A limit test was performed therefore statistical analysis to determine the EC50 value was not necessary. The EC50 (48h) of the test item to Daphnia magna was determined to be greater than 100 mg/L based on nominal concentration.

Description of key information

The EC50 (48h) of the test item to Daphnia magna was determined to be greater than 100 mg/L (reference 6.1.3-1) according to OECD 202 (2004) in a static test system under GLP conditions.

Additional information

The EC50 (48h) of the test item to Daphnia magna was determined according to OECD 202 (2004) in a static test system under GLP conditions. Young Daphnia were exposed to aqueous test media containing the test item for 48 hours under defined conditions. Based on the results of the preliminary test (static test), the test item has no toxic effect on the daphnids up a concentration of 100 mg/L. Therefore, the main test was performed at a concentration level of 100 mg/L and a concurrent control. A static test was performed because the test item was stable in test water during the test period of 48 hours. The test item concentration of the test solutions was measured by LC/MS method at the start and end of the test. As the performed analytical determinations confirmed that the test item concentration remained within the range of ± 20 % of the nominal concentration, the biological results are reported based on the nominal concentration of the test item. Twenty Daphnia (divided into four replicates) was tested at the test concentration and in the untreated control. Each test vessel contained approximately 40 mL test medium. The test medium (dilution water) were the Elendt M4 Medium according to OECD guideline. Temperature and pH were measured with the suitable instruments at the start and at the end of the test. All of the measured values remained in the acceptable ranges. For the evaluation of the quality of the Daphnia clone and the experimental conditions, potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions. The 24h EC50 of the reference substance is determined to be 1.03 mg/L. The immobilisation of the test animals was recorded 24 and 48 hours after treatment. A limit test was performed therefore statistical analysis to determine the EC50 value was not necessary. The EC50 (48h) of the test item to Daphnia magna was determined to be greater than 100 mg/L based on nominal concentration.