Lecithins, hydrogenated

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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 203 (Fish, Acute Toxicity 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:

In order to check the initial concentrations and maintenance of the exposure concentration of the test item during the ecotoxicological testing, chemical analysis of test item in fish test solutions were analysed at initial time and after 96 hours of exposure.

Vehicle:

no

Details on test solutions:

According to the study monitor, the test item was not soluble in the test medium, a solubilisation protocol was carried out before the experimentation, according to the OECD n°23 guidance document on aquatic toxicity testing of difficult substances and mixtures.

Preliminary works (non GLP) were performed to define the solution preparation protocol in order to obtain the maximum achievable dissolved Carbon concentration of the test item in the test medium. No filtration was done because filtration of huge volume, whatever the porosity, showed technical issues because of clogging. Considering the aspect of the solution, decantation was not possible.

A study of stability of the test item was carried out under the testing conditions.

The solubilization protocol consisted in stirring the test item nominal loading rate in test medium during 72 hours, in the dark and 20 ± 2°C (the concentration was prepared by adding directly the test item in flask containing test medium).

According to the study monitor and the results of the preliminary test, this study was conducted on concentration level: 100 mg/L, Limit test.

The test was carried out under static conditions, which means that the solutions were not renewed at 24h.

The test contained a total of 2 aquariums, one for the control and one for the test solution 100 mg/L.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Test system (fish) supplier:
Elevage de la grande rivière
La Fond Garel
F-69490 SAINT FORGEUX

Prefectural approval : A69-200-1301
Batch number of fish 190219
Feeding none
Number of fish / aquarium (Charge) 3 Fish ( 0.8 g/L)
Size of Aquarium 15cm * 10cm * 15 cm containing 1.0L of the test solution
Test solutions temperatures 22.6 to 23.6 °C
Light intensity 16 hours photoperiod daily

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

290 mg/L CaCO3

Test temperature:

22.6 to 23.6 °C

pH:

7.3

Dissolved oxygen:

78 mg/L

Nominal and measured concentrations:

Nominal loading rate (mg/L) : 100

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Details on results:

no death observed.

Results with reference substance (positive control):

The toxic response obtained on the reference item K2Cr2O7 for the Fish batch number 140519 gives a LC50-24h of 213 mg/L [185 – 250], in accordance with historical data obtained by the laboratory.

Validity criteria fulfilled:

yes

Conclusions:

An OECD 203 test was performed and presented the following results:
EL50 >100mg/L

Executive summary:

The aim of this study was to assess the effects of the test item on the fish Danio rerio, according to the OECD 203 guideline, Limit test (100 mg/L) in static conditions.

 

According to the study monitor, chemical analyses of the test item in the test solutions were performed during the test.

 

Validity criteria conformity:

Criteria	Validity for OECD 203	Validity for the test
Control mortality	≤ 1 fish	Yes (0)
Conditions	Constant	Yes (22.5 to 23.8 °C)
Dissolved oxygen concentration	> 60%	Yes (82%)
Concentrations maintaining	± 20%	Yes (0.0%)

All the validity criteria were successful.

The results obtained for the test item on the toxicological endpoint “mortality” give an LL₅₀ higher than 100 mg/L(highest tested concentration), values expressed in nominal test item loading rate.

Description of key information

The aim of this study was to assess the effects of the test item on the fish Danio rerio, according to the OECD 203 guideline, Limit test (100 mg/L) in static conditions.

 

According to the study monitor, chemical analyses of the test item in the test solutions were performed during the test.

 

Validity criteria conformity:

Criteria	Validity for OECD 203	Validity for the test
Control mortality	≤ 1 fish	Yes (0)
Conditions	Constant	Yes (22.5 to 23.8 °C)
Dissolved oxygen concentration	> 60%	Yes (82%)
Concentrations maintaining	± 20%	Yes (0.0%)

All the validity criteria were successful.

The results obtained for thetest itemon the toxicological endpoint “mortality” give anLL₅₀higher than 100 mg/L(highest tested concentration), values expressed in nominal test item loading rate.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L