Extract obtained from defatted powder of Theobroma cacao (Malvaceae) by extraction with water and ethanol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December, 2012 to April, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 203.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Cocoa Powder (High Fat)

IUPAC Name:

Cocoa Powder (High Fat)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test substance name: Cocoa Powder (22.5% lipid)
Batch number: BHF092012
Description: Brown solid
Purity: Not supplied
Storage: Room temperature (15 - 30°C), desiccated and protected from light

Sampling and analysis

Analytical monitoring:

no

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Healthy Oncorhynchus mykiss (rainbow trout) were supplied by Brow Well Fisheries, United Kingdom, details of which are maintained in Smithers Viscient (ESG) Ltd. records. The fish were acclimatised to the test conditions for at least 12 days prior to testing. The mortality rate of the stock batch of fish was 0% in the seven days prior to the definitive test. Fish were selected at random from the holding tank and allocated to the test vessels at the start of each phase of testing. The fish were not fed for at least 24 hours before the start of the definitive test and were not fed throughout the test. At the end of the test, the total length and wet weight of ten fish, selected at random from those used in the test, were determined.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

Not reported for the 100 mg/l loading rate. 72 mg/l in the control.

Test temperature:

14.5ºC at the start of the test.

pH:

7.13 at the start of the test.

Dissolved oxygen:

9.25 mg/l at the start of the test.

Nominal and measured concentrations:

The definitive test was conducted at a single nominal test substance concentration of 100 mg/l loading rate WAF.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Parameter	Toxicity Value (mg/l)
	24 hours	48 hours	72 hours	96 hours
LL50	>100	>100	>100	>100
NOELR	100	100	100	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The validity criteria for control mortality and dissolved oxygen (>60% ASV) were both satisfied. The test was therefore considered to be valid.

Conclusions:

Based on nominal concentrations, the 96-hour NOELR was considered to be >100 mg/l loading rate WAF. It is concluded that Cocoa Powder (22.5% lipid) was considered not to be toxic to Oncorhynchus mykiss at 100 mg/l loading rate WAF under the conditions of this test.

Executive summary:

The potential for the test substance to be acutely toxic to fish was determined in accordance with the OECD Guideline for Testing of Chemicals 203. Due to the complex nature of the test substance, it was considered that a Water Accommodated Fraction (WAF) approach was the most suitable method of test media preparation. The study was conducted using a semi-static test design with daily renewal of test media during the test. Based on the results of the range-finding test, which is not fully reported, a definitive test was conducted at a single nominal test substance concentration of 100 mg/l loading rate WAF. Based on nominal concentrations, the 96-hour NOELR was considered to be >100 mg/l loading rate WAF. It is concluded that Cocoa Powder (22.5% lipid) was considered not to be toxic to Oncorhynchus mykiss at 100 mg/l loading rate WAF under the conditions of this test.