Reaction product of castor oil with glycerol

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Mar - 21 Aug 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Version April 2004

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

(EC) No.440/2008

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of certificate: 19.11.2018 (The Department of Health of the Government of the United Kingdom)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of castor oil with glycerol

EC Number:

949-117-7

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Reaction product of castor oil with glycerol

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all concentrations, taken at start and end of the 48 hour exposure period
- Sampling method: Samples were taken from the control and each test group from the bulk test preparation at 0 hours and from the pooled replicates at 48 hours for quantitative analysis
- Sample storage conditions before analysis: 48-hour test samples were stored frozen prior to analysis. Duplicate sets of samples were taken at 0 and 48 hours and stored frozen for further analysis if necessary.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A nominal amount of test item (100 mg) was dissolved in test water and the volume adjusted to 1 liter to give the 100 mg/L test concentration from which a series of dilutions was made to give further test concentrations of 32, 10, 3.2 and 1.0 mg/L. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Age at study initiation (mean and range, SD): ≤ 24 h
- Method of breeding: Adult daphnids were maintained in 150 mL glass vessels containing 100 mL Elendt M7 medium in a temperature controlled room maintaining the water temperature at 18 to 22 °C, fed daily with a mixture of algal suspension (Pseudokirchneriella supcapitata), gravid adults were isolated the day before initiation of the test
- Source: in-house culture
- Feeding during test: no

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

20 °C - 21 °C

pH:

7.8 - 8.5

Dissolved oxygen:

7.9 - 9.0 mg O2/L

Nominal and measured concentrations:

-Nominal: 1.0, 3.2, 10, 32 and 100 mg/L
- Measured 0 h: 0.863, 3.04, 9.70, 28.8, 101 mg/L
- Measured 48 h: 1.11, 3.39, 10.7, 34.2, 112 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 150 mL glass vessels
- Type (delete if not applicable): open
- Volume of solution: 100 mL
- Aeration: none
- 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 M7 medium), pH of 7.9 ± 0.3
- Intervals of water quality measurement: Water temperature was measured at 0, 24, and 48 h, pH and dissolved oxygen was measured at 0 and 48 h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light / 8 hours dark cycle with 20 minute dawn and dusk transition periods
- Light intensity: 764 - 900 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Immobilization or adverse reactions to exposure recorded at 24 and 48 hours after the start of exposure.

RANGE-FINDING STUDY
- Range-finding study: yes
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed at the test concentrations of 0.10 and 1.0 mg/L, immobilization was observed at 10 and 100 mg/L, reduced mobility was observed in the control at 10 mg/L test concentration.

Reference substance (positive control):

yes

Remarks:

potassium dichromate as the reference item was performed twice in a 12 month period

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

41 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 30 - 57 mg/L (95% confidence limits)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Sub lethal effect of exposure was observed in the 1.0, 3.2, 10 and 32 mg/L test concentrations. This response was being covered with debris. The presence of debris is considered to be due to a potential reaction between the test item and media which may be accompanied by the visual presence of precipitated test item/salts in the test vessels themselves. As all preparations had been noted as being clear colorless solutions throughout the duration of the test, the extent of debris was considered to be minimal.

Results with reference substance (positive control):

- positive control test was conducted between 25 Sep - 27 Sep 2018 with concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg potassium dichromate/L
- EC50 (24 h) = 1.1 mg/L; EC50 (48 h)= 0.80 mg/L, the results from the positive control with potassium dichromate were within the normal range for this reference item

Reported statistics and error estimates:

All results were calculated using ToxRat Professional Version 3.2.1. ToxRat® Solutions GMBH 2001-2015

Any other information on results incl. tables

Table 1. Mean Immobilization of daphnids

Concentration [mg/l]	Immobile daphnids (n=20)
	absolute		%
	24 h	48 h	24 h	48 h
Control	0	0	0	0
1.0	0	0	0	0
3.2	0	0	0	0
10	0	0	0	0
32	1	5	5	25
100	20	20	100	100

 

 

Table 2. Cumulative biological observations

Concentration [mg/l]	Observations (n=20)
	24 h	48 h
Control	20 N	20 N
1.0	20 N	17 N; 3 C
3.2	20 N	18 N; 2 C
10	20 N	17 N; 3 C
32	19 N	10 N; 10 C
100	AI	AI

N = Normal

C = Covered in debris-considered to be present due to a potential reaction between the test item and media

AI = All Daphnia immobilized

 

Table 3: Validity criteria for OECD 202

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0%	Yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	≥7.9 mg/L	Yes

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

See Table 3 in "any other information on results incl tables"