Lecithins, hydrogenated

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch number 8613
Manufacturing date October 25, 2018
Active substances [CAS number]* Lecithins, hydrogenated [92128-87-5]

Test item physical state Slight yellow powder
Test item quantity received at test facility 150 g
Packaging Plastic bag
Storage conditions Ambiant temperature ( 20 ± 5°C), Hydroscopic and keep away from light
Expiry date October 24, 2019

Analytical monitoring:

yes

Details on sampling:

The daphnids medium is the matrix and were prepared according to Standard Operating Procedure (SOP) MOP 3124. A nominal concentration at 1000 mg/L was prepared by direct addition (by weighing) from the test item with the daphnids medium.

The mixing protocol was the following:

The prepared sample was stirred 72 hours at 20 ± 2°C and at darkness. After this step, the test solutions plus Control sample were filtered with a whatman filter 40 (porosity size: 8 µm) to remove suspended particles: solutions obtained are named WAF (Water Accommodated Fraction).The sample to the nominal concentration of 1000 mg/L plus control was analyzed at initial time and was placed in the climatic chamber at 20± 1°C darkness, in static condition during 48 hours without daphnids and in covered glass tubes
After 48 hours of exposure, the samples were analyzed in order to check the chemical stability of the test item.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna Straus, clone number 5, from at least the third generation (i.e. the third brood) obtained with a non-cyclic parthenogenesis reproduction.
The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any toxic vapour and in medium M4.
Daphnids used in this experimentation were previously filtered in order to obtain animals from a size between 560 μm and 800 μm (corresponding to daphnids less than 24 hours old).

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

19.8 – 20.1°C

pH:

WAF Control :
T0: 8.1
T48h: 7.7
WAF 1000:
T0: 7.9
T48h: 7.6

Dissolved oxygen:

WAF Control :
T0h: 9.0
T48h: 8.9

WAF1000:
T0h: 9.0
T48h: 8.9

Nominal and measured concentrations:

Nominal test item loading rate (mg/L) : 1000
Test item (mg) at the start (T0h) : 500.06
Test medium final volume (L) at T0h : 0.5

Details on test conditions:

This study was conducted on one concentration level: 1000 mg/L.
The test contained a minimum of 12 glass test tubes as follow:
- Control: 6 replicates
- Concentration 1000 mg/L: 6 replicates
The pH of the solutions remained in the range 6 – 9, the pH adjustment was not made.
Each glass test tube contained 10 mL of each test solution and 5 daphnids; they were covered in order to avoid evaporation and dust deposition.

INCUBATION:
The test was performed in the dark between 18 and 22°C but constant within ±1°C. Daphnids were not fed during the test period.
Observations of the daphnid’s immobility and behaviour were done after 24 and 48 hours in control and exposed groups.
Any sign of stress observed on the daphnids after 24 and 48 hours of exposure to the test item were reported.
pH and dissolved oxygen were measured at the start and at the end of the test (including Controls).

DATA AND CALCULATION:
ELX values for each observation time (24 and 48 hours) were evaluated from immobilisation raw data obtained without scientific software because no daphnia was immobilized.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Executive summary:

The aim of this study was to determine the acute toxicity of the test item on the daphnids Daphnia magna, according to the OECD guideline 202. The daphnids are exposed to Water Accommodated Fractions (WAFs) of the test item, following the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23)

Validity criteria conformity:

	Values for OECD 202	Validity criteria for the test
Immobilised daphnids in control	<= 10%	OK (0%)
Dissolved oxygen concentration	>= 3 mg/L	OK (8.9mg/L)

All the validity criteria were successful.

The results obtained for the test item on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than 1000 mg/L, based on nominal test item loading rate.

Description of key information

The aim of this study was to determine the acute toxicity of the test item on the daphnids Daphnia magna, according to the OECD guideline 202. The daphnids are exposed to Water Accommodated Fractions (WAFs) of the test item, following the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23)

Validity criteria conformity:

	Values for OECD 202	Validity criteria for the test
Immobilised daphnids in control	<= 10%	OK (0%)
Dissolved oxygen concentration	>= 3 mg/L	OK (8.9mg/L)

All the validity criteria were successful.

The results obtained for the test item on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than 1000 mg/L, based on nominal test item loading rate.

The aim of this study was to determine the acute toxicity of the test item on the daphnids Daphnia magna, according to the OECD guideline 202. The daphnids are exposed to Water Accommodated Fractions (WAFs) of the test item, following the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23)

Validity criteria conformity:

	Values for OECD 202	Validity criteria for the test
Immobilised daphnids in control	<= 10%	OK (0%)
Dissolved oxygen concentration	>= 3 mg/L	OK (8.9mg/L)

All the validity criteria were successful.

The results obtained for the test item on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than 1000 mg/L, based on nominal test item loading rate.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1 000 mg/L