Phytosteryl Macadamiate

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

Study period:

2015-09-01 - 2015-12-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP-Study was performed according to an internationally accepted guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Purity: 99.98% UVCB substance, 0.02% Tocopherol

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

The water-accommodated fraction (WAF) was prepared for the test. This was done by weighing the load of 101.0 mg/L, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 µm nylon filters.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna
Variety STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
In-house breeding since 27. September 2007
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The husbandry is performed similar to the method described in EN ISO 6341, following SOP 115 002 01 („Zucht und Hälterung von Daphnia magna STRAUS“), Version 12.
Vessels preserving glasses, nominal volume 2 L
Medium M4-Medium (recipe of ELENDT
Food unicellular green algae (Desmodesmus subspicatus)
Medium renewal twice a week
Photo period 16/8 hours, using neon tubes
Temperature 20 ± 2 °C

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

2.502 mmol/l

Test temperature:

19.6 – 20.9 °C

Dissolved oxygen:

8.6 - 8.8 mg/l

Nominal and measured concentrations:

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 DOC concentrations in the treatment were in a similar low range as the blank control. Higher measured DOC concentration at the end of the test might be caused by the presence of the daphnia.
Therefore, the determination of the biological results was based on the nominal concentration which represent the nominal loadings of the test item.
Nominal: 100 mg/l

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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 0.6 – 1.7 mg/L.

Any other information on results incl. tables

 Immobility

Nominal Concentration in mg/L	Immobility 24 hours					Immobility 48 hours
	absolute				in %	absolute				in %
Blank control	0	0	0	0	0	0	0	0	0	0
100	0	0	0	0	0	0	0	0	0	0

pH and O₂

Nominal Concentration in mg/L	pH		O2-Concentration in mg/L
	0 h	48 h	0 h	48 h
Blank control	7.7	7.7	8.8	8.6
100	7.7	7.7	8.8	8.6

Analytical Determinations

Nominal Concentration Test Item	Measured DOC  t = 0 h	Measured DOC  t = 48 h
mg/L	mg/L	mg/L
Blank control	0.01	3.43
100	0.02	1.92

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The following results were determined for the test item PHYTOSTERYL MACADAMIATE (species: Daphnia magna).

24h-NOEC ≥ 100 mg/L
48h-NOEC ≥ 100 mg/L
24h-EC50 > 100 mg/L
48h-EC50 > 100 mg/L

Executive summary:

One valid experiment was performed.

The study was performed using one concentration containing 100 mg/L nominal concentration. 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 controlin a current reference study.The 24h-EC50 value was determined as 1.6 mg/L, lying within the demanded range 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 by DOC measurement. The measured DOC concentrations in the treatment were in the same low range as in the control. Therefore, no calculation from carbon content of the test item and DOC measurement was possible. The determination of the results was based on the nominal concentrations which represent the nominal loadings of the test item. This is in agreement with OECD guidance document no. 23. For tests with chemicals that cannot be quantified by analytical methods, the effect concentration can be expressed based on the nominal concentrations (loading rates).

 

The following results were determined for the test item PHYTOSTERYL MACADAMIATE (species:Daphnia magna).

 

24h-NOEC≥100 mg/L
48h-NOEC≥100 mg/L
24h-EC50 > 100 mg/L
48h-EC50 > 100 mg/L