Reaction product of 6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide, itaconic acid and ethylene glycol

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:

2012-05-09 - 2013-01-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are given in detail.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

The maximal solubility in daphnia test medium was determined during validation of the analytical method as 12 mg/L. Because stability in test medium after 48 hours was only 83.4% no saturated solution prepared. Acetone was used as solvent to prepare the test solution at the limit of solubility directly before the start of the test. A stock solution containing 12040 mg/L in acetone was prepared.

The concentration of the stock solution was 1000-fold higher than the nominal concentration in the treatment (12 mg/L). For the solvent control, acetone in a concentration of 1 mL/L was used.

Note: concentration of the solvent acetone surpasses the recommended solvent concentration (as stated in OECD document no. 23: "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures"). It was proven in several experiments, though, that a concentration of 1 mL/L is tolerated by the daphnia.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species:Daphnia magna
Variety:Straus
Strain:Berlin
Sex:female
Age:between 0 and 24 hours
Origin:Umweltbundesamt Berlin
Animal Husbandry: Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The husbandry is performed similar to the method described in EN ISO 6341, following SOP 115 002 01 ("Zucht und Hälterung von Daphnia magna Straus"), edition 10, adopted 04. Nov. 2010.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

2.502 mmol/l

Test temperature:

20.9 - 21.7 °C

pH:

7.7 - 7.9

Dissolved oxygen:

8.2 - 8.8 mg/l

Nominal and measured concentrations:

12 mg/l (limit of water solubility

Details on test conditions:

Experimental Conditions

Test vessels glass beakers, nominal volume 50 mL, tall shape

Feeding none

Lighting none

Date of performance 17. - 19. Jul. 2012

Treatments 12 mg/L

Temperature 20.9 - 21.7 °C

Duration 48 hours

Observation times 24 and 48 hours

Replicates four vessels, each containing 20 mL test solution and 5 daphnia

Control four vessels, each containing 20 mL dilution water and 5 daphnia

Solvent Control four vessels, each containing 20 mL dilution water, 1 ml/L acetone and 5 daphnia

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

>= 7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

The 24h-EC50i of potassium dichromate was determined as 1.5 mg/L in a current reference test, lying within the demanded range of 0.6 - 1.7 mg/L.

Immobilities

Nominal Concentration in mg/L	Immobility 24 hours					Immobility 48 hours
	abs.				in%	abs.				in%
Blank control	0	0	0	0	0	0	0	0	0	0
Solvent control	0	0	0	0	0	0	0	0	0	0
12mg/L	0	0	0	0	0	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The following results were determined for the test item Ukanol FR 70 (species: Daphnia magna).

24h-NOEC ≥ 7.0 mg/L
48h-NOEC ≥ 7.0 mg/L
24h-EC50i > 7.0 mg/L
48h-EC50i > 7.0 mg/L

Executive summary:

This study was performed in order to evaluate the toxic potential of Ukanol FR 70 towards freshwater shrimp, using the species Daphnia magna. Daphnia magna Straus, which belongs to the family of crustacea, was chosen in the guideline as a typical part of zooplancton.

The main study was performed as a limit test using one concentration of 12 mg/L, corresponding to maximal solubility of the test item in daphnia test medium. The maximal solubility in test medium was determined during validation of the analytical method. Twenty 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 immobilisation was observed in the treatment. None of the animals were immobilised in the control and in the solvent control. The 24h-EC50i of potassium dichromate was tested in a current reference test. The value was determined as 1.5 mg/L, lying within the demanded range of 0.6 - 1.7 mg/L. At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC-determination. The measured concentration after 0 hours was 91 % of the nominal concentration. The recovery after 48 hours was only 41 % of the start concentration. During validation of the analytical method, the test item had shown sufficient stability in daphnia test medium (83.5 % after 48 hours). Therefore, the insufficient stability within this study might be caused by ingestion or adsorption of test item by the daphnia. As the test item did not show sufficient stability during the test, the determination of the biological results was based on the geometric mean of the measured start and end concentration of the test item. The following results were determined for the test item Ukanol FR 70 (species: Daphnia magna):

24h-NOEC ≥ 7.0 mg/L

48h-NOEC ≥ 7.0 mg/L

24h-EC50i > 7.0 mg/L

48h-EC50i > 7.0 mg/L

Description of key information

The following results were determined for the test item Ukanol FR 70 (species: Daphnia magna).

24h-NOEC ≥ 7.0 mg/L

48h-NOEC ≥ 7.0 mg/L

24h-EC50i > 7.0 mg/L

48h-EC50i > 7.0 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

7 mg/L