Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products

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:

04-01-2015 to 20-01-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP. This limit test was performed according the OECD Threshold Approach for Acute Fish Toxicity Testing

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Principles of method if other than guideline:

The procedure used is based on the OECD Threshold Approach for Acute Fish Toxicity Testing. Starting point for this limit test is the lowest EC50 as derived from the algae test, 3.1 mg/L

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: at 0 and 3.1mg/L
- Sampling method: in duplicate at renewal from fresh and old solutions (analysed were single samples at 0 h fresh, 24 h old, 72 h fresh and 96 h old)
- Sample storage conditions before analysis: frozen

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stirring for 23 hours, standing 1 hour and transfer via tube with Nescofilm seal by mid depth syphoning
- Differential loading: 3.1 mg/L (68.2 mg in 22 L)
- Controls: untreated
- Evidence of undissolved material: microscopic evaluation did not show any undissolved material in the WAF

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Length at study initiation: 4.7 cm (sd = 0.2)
- Weight at study initiation: 1.26 g (sd = 0.19)
- Feeding during test: none
- Loading: 0.44 g/L

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): yes (except feeding)
- Type and amount of food: commercial trout pellets until 24 h before test start
- Feeding frequency: not indicated
- Health during acclimation (any mortality observed): no mortality, no abnormalities

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

renewal of the test solutions at 24, 48, and 72 hours

Hardness:

140 mg/L as CaCO2

Test temperature:

in fresh and old solutions at 0, 24, 48, 72 and 96 h: 15 °C

pH:

in fresh and old solutions at 0, 24, 48, 72 and 96 h: 7.6 -8.4

Dissolved oxygen:

in fresh and old solutions at 0, 24, 48, 72 and 96 h: 9.6-10.7 mg/L (95-106% of saturation)

Nominal and measured concentrations:

Nominal: 0 and 3.1 mg/L
Measured: TWA: 0.27 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20L (amount of test solution not indicated)
- Type: covered
- Material: glass
- Aeration: yes
- Renewal rate of test solution (frequency): every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates):1
- Biomass loading rate: 0.44 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite
Series 500) and partrly softened
- Total organic carbon: 140 mg/L as CaCO2
- Water quality measurement: dated January to December 2011

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16 h light 8 hours dark
- Light intensity: not indicated
- Water temperature: 15 °C

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects at 3, 6, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS: 0 and 3.1 mg/L (based on outcome of algae test according to OECD Threshold Approach for Acute Fish Toxicity Testing)

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 3.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 0.27 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

dissolved

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0/7
- Mortality at 100 mg/L : 0/7

Validity criteria fulfilled:

yes

Conclusions:

The LL50 for the test substance is > 3.1 mg/L

Executive summary:

Rainbow trouts (7/concentration) were exposed to the test substance at a loading rate of 0 and 3.1 mg/L in a semi-static test (96 h) with 24 h renewals. The prepared WAF did not induce mortality at 3.1 mg/L (measured TWA 0.27 mg/L). Therefore it is concluded that the LL50 is > 3.1 mg/L.

Description of key information

Rainbow trouts (7/concentration) were exposed to the test substance at a loading rate of 0 and 3.1 mg/L in a semi-static test (96 h) with 24 h renewals. The prepared WAF did not induce mortality at 3.1 mg/L (measured TWA 0.27 mg/L). Therefore it is concluded that the LL50 is > 3.1 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

mg/L

Additional information

The study is conducted as a limit test at the no effect concentration as reported in the most sensitive species (algae). No actual LC50 could be established as in the fish study the concentration tested did not induce mortality.