Sunflower oil, ester with sorbitol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sunflower oil, ester with sorbitol

EC Number:

306-248-9

EC Name:

Sunflower oil, ester with sorbitol

Cas Number:

96690-53-8

IUPAC Name:

sunflower seed oil sorbitol esters

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

Test concentration: 100 mg/L

Stock solution: Directly weighing

Dispersion treatment: The test medium was mixed with an ultraturrax (1 min, 17000 rpm).

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST SYSTEM: Dania rerio (zebrafish), Gnathostoma, Pisces, Osteichthyes, Teleostei, Clupeiformes, Cyprinidae

Reason for the selection of the test system: According to the guideline Danio rerio is suitable for this kind of study.

Origin: AQUARIUM AM AEGI, Volgersweg 6, D-30175 Hannover; All fish used in the test originated from the same delivery of the supplier.

Holding: Holding was performed at the test facility at 23 ± 2 °C and diffuse light (0.1-1 µmol photons · m-2 · s-1 , natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study starts were used in the test. No disease treatments were administered throughout holding and testing.

Water: Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine. Nominal water parameters:
Total hardness: 10- 250 mg CaCO3/L
pH-value: 6.0 - 8.5
The water is analysed biannual ace. to German tap water regulation.

Feeding: Food was provided 3 times per week. The amount of food was 4% of the fish body weight per feeding day. The test fish were not fed 24 h before the test started.

Food: Star perlets; SERA GMBH, D-52518 Heinsberg

Average body length at the test start: 2.71 cm
Average body weight at the test start: 0.19 g

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

46 mg/l CaCO3

Test temperature:

23-24°C

pH:

7.51-7.73

Dissolved oxygen:

94-100% oxygen suration

Nominal and measured concentrations:

nominal: 100 mg/l

Details on test conditions:

Test duration: 96 h

Test vessel: Glass-aquaria loosely covered by glass tops were used.

Test volume: 10 L per vessel.

Aeration: Gentle aeration was provided.

Dilution water: Same as for holding.

Number of test fish: 7 zebrafish were used per limit concentration and control.

Loading, length of fish: Fish density in the tanks was less than 1 g fish per liter test solution.

Replicates: One replicate for limit concentration and control.

Introduction of fish: Fish were introduced randomly to individual replicates.

Feeding of test fish: The fish were not fed during the test.

Water temperature: 23 ± 2 °C

Dissolved oxygen concentration: Not less than 60 % of air saturation value.

Light intensity: 0.1 - 10 µmol photons · m-2 · s-1

Photoperiod: A natural photoperiod occurred during the test.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

LC50

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:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The nominal test item concentration of 100 mg/L caused no mortality or non-lethal effects.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The nominal test item concentration of 100 mg/L caused no mortality or non-lethal effects.

Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2008- 05-26 to 2008-05-30 at DR.U.NOACK-LABORATORIEN, 31157 Sarstedt, Germany. A static limit test was conducted with a single test item concentration of 100 mg/L. Duration of the test was 96 h. 7 test organisms were exposed to the test concentration and control. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits. DOC analysis at the beginning of the test was carried out.

The nominal test item concentration of 100 mg/L caused no mortality or non-lethal effects.