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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 Februari 2017 to 27 May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Principles of method if other than guideline:

In view of the low solubility of the substance a water accomodated fraction was tested

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 18, 32 and 56 mg/L
- Sampling: duplicate samples from fresh solutions on day 0, 5, 12 and 20 and from old solutions on day 1, 6, 13 and 21 of all replicates (analyses on pooled replicate samples)
- Sample storage conditions before analysis: frozen

Vehicle:

no

Details on test solutions:

- Method: stirring for 23 hours, standing 1 hour and transfer via tube by mid depth syphoning
- Differential loading: 100 mg/L (500 mg in 5L water)
- Controls: untreated

All WAFs were clear colorless water columns with varying sizes of brown stringy test item on the surface on day 0 and 1
On day 2 5.6, 10, 18 and 32 mg/L loading rates were observed to be a clear colorless water columns with oily test item on the surface .
From day 2 onwards 5.6, 10 and 18 mg/L loading rates were observed to be a clear colorless water columns with brown/yellow oily globules/deposits of test item on the surface.
Microscopic inspection of the WAFs on all days showed no micro-dispersions or undissolved test item to be present. After siphoning and for the duration of the test, the 5.6, 10 and 18 mg/L loading rates were observed to be a clear, colorless solutions

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory culture
- Age of parental stock : <24 hours
- Feeding during test: daily to achieve 0.1-0.2 mg C/daphnid/day
- Food type: algae suspension ( 5 to 10 µL) or Tetramin® flake food suspension (20 µL)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Remarks on exposure duration:

according to the guideline

Hardness:

250 to 280 mg/L as CaCO3

Test temperature:

20-22 °C

pH:

7.2-8.1

Dissolved oxygen:

8.1-9.1 mg/L

Salinity:

NA

Nominal and measured concentrations:

nominal 0, 5.6, 10, 18, 32 and 56 mg/L
measured:

Details on test conditions:

TEST SYSTEM
- Test vessel: 150 mL glass vessel containing 100 mL test medium
- Type: closed
- Aeration: none
- Renewal rate of test solution: daily
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (Elendt M7 medium)


OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16 light/ 8 dark
- Light intensity: 377-586 lux

EFFECT PARAMETERS MEASURED :
daily mortality parental daphnids; number of F1 daphnia and (discarded) unhatched eggs
at renwals: number of young daphnids (live and dead) and unhatched eggs as saved on the mesh

TEST CONCENTRATIONS
- Range finding study: 0.1, 10 and 100 mg/L 100% mortality at 100 mg/L, trapping at surface at 0.1 and 10 mg/L, number of young in first brood at 1 and 10 mg/L within control ranges

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate

Basis for effect:

reproduction

Remarks:

and immobilisation

Duration:

21 d

Dose descriptor:

EL10

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate

Basis for effect:

immobilisation

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

21 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loding rate

Basis for effect:

immobilisation

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.84 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks:

an immobilisation

Details on results:

The NOEC is based on the lowest average concentration of the 4 measurements (day 20-21). This considered a worst case approach
Day of first young: day 7 at 0, 5.6, 10 and 18 mg/L
Total number of surviving adults on day 21: 9, 10, 9 and, 9 at 0, 5.6, 10 and 18 mg/L (all parental daphnid died on day 1-2 at 32 and 56 mg/L)
Total number of live young on day 21: 1192, 1513, 1435 and 1368 at 0, 5.6, 10 and 18 mg/L
Body length of surviving adults: no treatment related effects

Reported statistics and error estimates:

The 21-Day EL
EL50 (immobilization) values were calculated by the Maximum-Likelihood Probitmethod (Finney 1971) using ToxRat Solutions GMBH 2001-2010.
EL50 (reproduction) values after 21 days were calculated by the linear interpolation method using ToxCalc (1999).
For the estimation of the "No Observed Effect Loading Rate " (NOEL) the control and each test group
were compared using the Step-down Jonckheere-Terpstra test procedure with the Levene’s test on variance and homogeneity and the Shapiro-Wilk’s test on normal distribution
Daphnia lengths were compared by one way analysis of variance and test for lack of fit for the 3-param. normal CDF

 

Nominal Loading Rate (mg/L)	Total Number of Live Young	Percentage Survival of Parental (P) Generation	Number of Live Young Per Parent Surviving to the End of the Test
control	1192	90	123
5.6	1513	100	151
10	1435	90	159
18	1368	90	151
32	0	0	0
56	0	0	0

 

Validity criteria fulfilled:

yes

Conclusions:

The substance did not affect immobility and reproduction of daphnia exposed at 18 mg/L. The NOELR is 18 mg/L

Executive summary:

Daphnids were exposed to 0, 5.6, 10, 18, 32 and 56 mg/L test substance during 21 days. Renewal of the test solutions was done daily. All parental daphmids died by day 1 or 2 at 32 and 56 mg/L. No effects on immobility and reproduction were found at 18 mg/L and below. No effects were found on daphnia lenght.The analyses for accuracy of preparation at the NOELR that the actual concentrations varied. The worst case average measurement was taken as the NOEC (0.84 mg/L). The NOELR is 18 mg/L.

Description of key information

Daphnids were exposed to 0, 5.6, 10, 18, 32 and 56 mg/L test substance during 21 days. Renewal of the test solutions was done daily. No effects on immobility and reproduction were found at 18 mg/L and below. The analyses for accuracy of preparation at the NOELR that the actual concentrations varied. The worst case average measurement was taken as the NOEC (0.84 mg/L)

The NOELR is 18 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.84 mg/L