Castor Oil, reaction product with Soybean Oil

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:

2011-05-04 till 2011-06-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

Two test fish had a somewhat larger size than the one recommended in the test guideline for zebra fish.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Two test fish had a somewhat larger size than the one recommended in the test guideline for zebra fish.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Sampling schedule:
Control: at 0 and 96 hours
Test concentration: at 0 and 96 hours

Vehicle:

no

Details on test solutions:

A direct weighing was prepared to produce the only test concentration. 500.2 mg of the test item were added to 5 litres of dilution water, treated with an ultra turrax for 60 sec. at 8000 rpm and was then stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using an aseptic filter with a pore size of 0.45 + 0.2 μm . The pH was measured to be 7.3. Finally 7 fish were given to the test item concentration as well as to the control.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Name: Zebra fish (Danio rerio)
Source: Aqua KlöGer (Germany)
Acclimatisation: Stock held since 2011-04-19 and acclimatised to the test conditions since then.
Feeding: Commercial fish food daily. Feeding discontinued 24 h prior to test start.
Mortalities during acclimatisation period: < 5 %
Mean standard length (n = 14): 3.4 cm

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

14 °dH (= 250 mg/L CaCO3)

Test temperature:

22.0 - 22.7 °C measured at each test vessel at the beginning and the end of the test

pH:

7.1 - 7.4 measured at each test vessel at the beginning and the end of the test

Dissolved oxygen:

8.1 - 9.3 mg O2/L with 91 - 106 % saturation measured at each test vessel every 24 hours

Nominal and measured concentrations:

100 mg/L (nominal) plus control

Details on test conditions:

An acute daphnia and an algae toxicity test preceded the fish test. They provided information about the concentration which was used in the fish test.

The fish test was conducted as static test with the test medium unchanged throughout the duration of the test. As no toxic effects against fish were observed, no statistical analysis was required to determine the LL 50. Additionally any abnormal behaviour or appearance of the fish was reported every 24 hours.

During the test a temperature range of 20 - 24 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °C in each individual test. The temperature, pH and oxygen values were measured at the beginning of the test and every 24 hours thereafter.

Exposure conditions
Test vessels: glass aquaria holding 5 L of test media covered by glass plates
Experimental design: 1 test concentration plus 1 control, 7 fish per test concentration, no feeding during the exposure period static system
Method of initiation: fish were placed in prepared media
Loading: 0.45 g body weight (wet weight) per litre
Photoperiod: 16 h light: 8 h dark
Temperature: 22.0 to 22.7 °C
Aeration: gentle aeration via narrow glass tubes
Test item concentration: 100 mg/L
Method of administration: direct weighing
Medium renewal: none
Criteria of effects: The criterion of death used in this study was the absence of response to physical stimulation. In addition to observations on mortality at 2, 24, 48, 72 and 96 hours, type and incidence of sublethal effects compared with control fish were observed.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

mortality (fish)

Remarks:

and sublethal effects

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

mortality (fish)

Remarks:

and sublethal effects

Reported statistics and error estimates:

As no toxic effects against fish were observed, no statistical analysis was required to determine the LL 50.

Sublethal observations / clinical signs:

The substance is insoluble or poorly soluble in water. Therefore a suitable selective and sensitive chromatographic method for the determination of the test item in aqueous solutions could not be established.

No toxic effects against fish were observed at the limit of water solubility.

Validity criteria fulfilled:

yes

Remarks:

The mortality in the controls did not exceed 10 % by the end of the test; the dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period; the pH did not vary by more than 1 unit

Conclusions:

Danio rerio was exposed under static conditions for 96 h to one concentration (100 mg/L) of the substance. No toxic effect was observed.

Executive summary:

The acute toxicity to fish (Danio rerio) to the substance was determined according to EU method C.1 "Acute toxicity for fish" (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 "Fish, Acute Toxicity Test" (1992).

A group of seven fish of the recommended size was exposed to a limit test concentration of nominally 100 mg/L of the substance and blank control solution for a period of 96 hours under static condition. A Water Accommodated Fraction (WAF) was used to test effects at a limit concentration of 100 mg/L, and no specific analysis was performed. The content of the test item during the exposure period was verified by DOC determination. Observations were made on the number of dead fish and the incidence of sublethal effects after 2, 24, 48, 72 and 96 hours of exposure. A LL50 of >100 mg/L was measured.

No toxic effect was observed.

The substance is insoluble or poorly soluble in water. Therefore a suitable selective and sensitive chromatographic method for the determination of the test item in aqueous solutions could not be established.

Description of key information

The acute toxicity to fish (danio rerio) to the substance was determined according to EU method C.1 "Acute toxicity for fish" (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 "Fish, Acute Toxicity Test" (1992).

A group of seven fish of the recommended size was exposed to a limit test concentration of nominally 100 mg/L of the substance and blank control solution for a period of 96 hours under static condition.

No toxic effect was observed at 100 mg/L (LL50 > 100 mg/L).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The key value should read LC50 > 100 mg/L as there was no effect in this limit test.