Castor oil, hydrogenated, ethoxylated

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 January 2018 to 27 January 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No 8147, Agricultural Production Bureau, November 24, 2000. Acute fish toxicity 2-7-1.

Principles of method if other than guideline:

no analytics were performed in absence of an analytical method suitable to measure the substance

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

A primary stock concentrate of the substance, with a nominal concentration of 10 g/L, was prepared by weighing a nominal 0.1 g of test substance (actual weight: 0.10008 g) into a weigh boat and rinsing into a 10 mL volumetric flask with tetrahydrofuran (THF) and making up to 10 mL volume. The concentrate was then manually shaken to mix. The resultant stock was observed to be clear and colourless and was used to prepare the test solution.
Total amount of THF present in the test solutions 100 ug/L.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Houghton Springs Fish Farm, Blandford Forum, DT11 OPD
- Age at study initiation (mean and range, SD): no data
- Length at study end (range): 54 – 57 mm
- Weight at study end (range): 2.09 – 2.50 g
- Loading rate: 1.7 g/L

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions: held in a fibreglass tank under artificial lighting and were contained in water as described for the test dilution water. They were held at 15 ±1°C and were fed daily using a commercial fish food.
- Health during acclimation: no mortality

FEEDING DURING TEST : none

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

74.0 mg/L as CaCO3

Test temperature:

15.0-16.0 °C

pH:

7.23-7.93

Dissolved oxygen:

8.59-9.85 mg/L

Nominal and measured concentrations:

nominal: 0 and 1.0 mg/L (additional vehicle control)

Details on test conditions:

TEST SYSTEM
- Test vessel: 15 L moulded glass tank
- Type (delete if not applicable): closed
- Fill volume: 10 L
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 1.7 g/L (end of test)

TEST MEDIUM / WATER PARAMETERS : tap water which had been coarsely filtered to remove particulate material, passed through activated carbon and dechlorinated using sodium thiosulphate. Salts were added, as required, to maintain minimum hardness levels, and the treated water passed through an ultraviolet steriliser and filtered to 10 µm.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8

EFFECT PARAMETERS MEASURED: mortality and symptoms of toxicity at 3, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS : derived from the results of a Daphnia sp. acute immobilisation test and an algal toxicity test. According to the OECD Threshold Approach, the lowest EC50 value from these studies was set as the threshold concentration for a limit test as described in OECD TG 203

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The loading rate was higher than prescribed by the guideline. This was evaluated to have had no effect on the results as oxygen concentrations in the aquaria were above saturation level and did not drop during the cause of the study.

Reported statistics and error estimates:

NA

Sublethal observations / clinical signs:

No analytical determination of the concentrations was possible in absence of a suitable analytical method. The substance is a complex UVCB and despite efforts no analytical method could be found.

mortalities and symptoms of toxicity

Nominal concentration	Cumulative percentage mortality observed
(mg/L)	3 hour	24 hour	48 hour	72 hour	96 hour
Control	0	0	0	0	0
Solvent Control	0	0	0	0	0
1.0	0	0	0	0	0

Seven fish were exposed in each test vessel

No symptoms of toxicity were observed.

Validity criteria fulfilled:

yes

Remarks:

with the exemption of the analytical verification of the doses

Conclusions:

The LC50 of the substance in fish is > 1.0 mg/L

Executive summary:

Subject	Determination of acute toxicity to rainbow trout (Oncorhynchus mykiss)
Guideline	OECD 203
Test species	Rainbow trout (Oncorhynchus mykiss)
Source of organisms	Houghton Springs Fish Farm, Blandford Forum, DT11 OPD
Test concentrations	Control, Solvent Control and a nominal concentration of 1.0 mg/L.
Length of test	96 hours, Static
Nominal test temperature	15±1°C
Results based on nominal concentrations	Time	LC50	Calculation method
	24 hours	>1.0 mg/L	Direct observation of the data
	48 hours	>1.0 mg/L	Direct observation of the data
	72 hours	>1.0 mg/L	Direct observation of the data
	96 hours	>1.0 mg/L	Direct observation of the data
	Based on absence of mortaility compared to the control, the 96 hour No Observed Effect Concentration (NOEC) was determined to be 1.0 mg/L and the Lowest Observed Effect Concentration (LOEC) was >1.0 mg/L.

Description of key information

In a limit test at 1.0 mg/L rainbow trouts were exposed for 96 hours in a static test according to OECD 203. Based on absence of mortality and signs of toxicity compared to the control, the 96 hour NOEC was determined to be 1.0 mg/L and the LC50 was >1.0 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 mg/L