Reaction mass of stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol and (24R)-ergost-5-en-3β-ol

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

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol

EC Number:

904-790-6

Molecular formula:

C28H48O; C29H50O; C29H48O

IUPAC Name:

Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

yes

Remarks:

reconstituted water (0.0500 g of test item into 500 mL of reconstituted water)

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

For the test concentration and for the negative control, group of 20 daphnids were used divided
into four replicates of five daphnids each. The daphnids were randomly distributed to the test
vessels at test initiation.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

The daphnids were observed by visual inspection for immobility after 24 and 48 hours of
exposure.

Test conditions

Hardness:

140 - 250 mg/L as CaCO3

Test temperature:

19.94 – 20.05°C

pH:

negative control: 7.61 - 7.38;
test item solution: 7.54 - 7.76.

Dissolved oxygen:

negative control: 7.61 – 7.80 mg O2/L
test item solutions: 7.48 – 7.76 mg O2/L

Nominal and measured concentrations:

negative control (reconstituted water without test item) and 100.0 mg test item/L.
Test concentration was chosen based on the results of an acute toxicity no GLP test .
The biological results were referred to test item nominal concentrations.

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

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of test item Mixture of phytosterols was tested on Daphnia magna under static conditions.
The EC10, EC20, EC50 and NOEC values at 24 and 48 hours were assessed.

Results, calculated in terms of nominal test item concentration, were as follows.

EC10/20/50: > 100 mg/l
NOEC: 100 mg/l