Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

EC Number:

941-319-3

Molecular formula:

Unknown (Substance of Unknown or Variable Composition)

IUPAC Name:

Esterification products of Grape seeds, Vitis vinifera L. (Vitaceae), extract with hexadecanoyl chloride

Test material form:

solid: particulate/powder

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Selection of the test system was made following the proposal of the guidelines.

Test solutions

Vehicle:

yes

Details on test solutions:

The dilution water was used as daphnia medium during the test. Dilution water specifications have been stated in attached study report on point 6.4 Dilution Water.
Deionised water with an enrichment of certain minerals (as demanded in the guidelines) is used in the test.
Weighted loads may vary within 5 %.
After preparation, the dilution water was aerated.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Selection of the test system was made following the proposal of the guidelines. 22 hours before the start of the test, the adult animals were separated from the young. 0.5 hours before test start, the adults were caught with the help of a glass tube, and the newborn Daphnia, aged between 0 and 23 hours, were sieved from the medium and immediately placed into a 250 mL-beaker containing dilution water. After a settling-in period of 30 minutes, animals which showed no apparent damage were used for the test. Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test Daphnia.

Study design

Test type:

static

Water media type:

other: Deionised water with an enrichment of certain minerals (as required in the guidelines)

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

Observation times 24 and 48 hours

Test conditions

Test temperature:

18.3 - 20.4 °C

pH:

7.7 (at 0h) - 7.7 (at 48h)

Dissolved oxygen:

9.4 mg/L at 0 hour and 8.6 mg/L at 48 hours.

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 20 Daphnia were exposed to the test item for 48 hours in a static test system. The concentration showed no toxicity. None of the animals were immobilised in the control.

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study. The 24h-EC50 value was determined as 1.6 mg/L, lying within the demanded range of
the guideline of 0.6 – 1.7 mg/L.

Reported statistics and error estimates:

No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met. The result of the test is considered valid.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met. The result of the test is considered valid.

Conclusions:

According to the study report, Palmitoyl grape seed extract has no toxic potential against Daphnia magna STRAUS.

Executive summary:

One valid experiment was performed. The study was performed using one concentration containing 100 mg/L. For the test concentration, 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted. The concentration showed no toxicity. None of the animals were immobilised in the control. Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study. The 24h-EC50 value was determined as 1.6 mg/L, lying within the demanded range of the guideline of 0.6 – 1.7 mg/L. At the beginning and at the end of the test, the content of the test item in the test solutions was estimated using DOC-determination. Because of the very low solubility in test medium, no calculation from carbon content of the test item and DOC measurement was possible. The measured concentration in the treatment was in a similar low range as the blank control and near the LOQ. Therefore, the determination of the biological results was based on the nominal concentration which represents the nominal loading of the test item. The following results were determined for the test item Palmitoyl grape seed extract (species: Daphnia magna). 48h-NOEC ≥ 100 mg/L; 48h-LOEC > 100 mg/L; 24h-EC50 > 100 mg/L and 48h-EC50 > 100 mg/L