Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-

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:

2005-03-07 to 2005-06-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

July 17th 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

July 31st 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

NA

Vehicle:

yes

Details on test solutions:

On each day of the test the "water accommodated fraction" (WAF) was prepared. This was done by weighing the nominal load of 100 mg/L, adding the corresponding amount of dilution water and stirring slowly for 24 h. The solution was left to stand for about 15 min. Then the lower phase was used for the test. Controls were treated similarly. A thin oily layer was formed on the water surface.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Strain: Hamilton Buchanan
- Source: Weiler´s Pet´s best, Turmstr. 6, 67433 Neustadt, Germany
- Age at study initiation: sexually immature young fish
- Length at study initiation: 2 ± 1 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same as test conditions
- Type and amount of food: warm-water food, daphnia, artemisia, tubifex or ground liver
- Feeding frequency: 3 times/day
- Health during acclimation: no mortality observed.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

no

Hardness:

94.3 mg CaCO3/L

Test temperature:

22 - 23°C

pH:

7.9 - 8.2

Dissolved oxygen:

> 7.9 mg/L or 92% throughout the test.

Salinity:

NA

Nominal and measured concentrations:

Nominal concentration: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Material, size, headspace, fill volume: maximal volume 10L
- Aeration: accomplished with glass tubes, frequency of bubbles 1/s
- Renewal rate of test solution (frequency/flow rate): Medium renewal every 24±1 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 7
- No. of vessels per control (vehicle): 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: good quality drinking water
- Total organic carbon: 0.82 mg/L
- Pesticides: < 0.1 µg/L
- Chlorine: 12.5 mg/L
- Conductivity: 249 µS/cm
- Culture medium different from test medium: no
- Interval of water quality measurement: yearly

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 12/12 hours using neon tubes

TEST CONCENTRATIONS

- test concentration: 100 mg/L

Range finding study
- Test concentration: 100 mg/L
- Results used to determine the conditions for the definitive study: As the test item is poorly water soluble, an oily film was observed already on the surface of the stock solution and on the treatment as well. The fish did not show any abnormal behaviour or mortality caused by this effect. But the concentration of the test item in the treatment is not reproducible. Therefore the experiment was repeated, but the WAF was prepared by stirring over 24 hours. The lower phase was used.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

24 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

24 h

Dose descriptor:

LL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

24 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

As no analytical method exists for the test item and because of the immediate hydrolysis of the test item, the hydrolysis product 2,2-Dimethyl-3-laureoyloxy-propanal should have initially been analysed. But this product is not stable as well. The soluble part is too little to be determined as TOC. Therefore no analytical determination of the test item in the test solutions was possible and the biological results were based on the nominal concentrations.
Because of immediate hydrolysis, no water solubility could be determined. The calculated value (following EPA-Calculation) is much smaller than 1mg/L. The water solubility of the product of hydrolysis is below 1 mg/L. Therefore it can be stated that the tested concentration is definitely above the limit of water solubility and thus the worst case was tested.

Results with reference substance (positive control):

Not applicable

Validity criteria fulfilled:

yes

Remarks:

No mortality occurred in the control. The concentration of dissolved oxygen stayed above 7.9 mg/L or 92 % throughout the test (100 % at 101300 Pa equals 8.57 mg/L, following DIN 38408 part 22).

Conclusions:

Sika Härter LJ was tested for acute toxicity to freshwater fish in a 96h-semi-static test according to EU method C.1. The test item showed no mortality up to a nominal concentration of 100 mg/L revealing a LC50 of greater than 100 mg/L and a NOEC of 100 mg/L.

Executive summary:

Sika Härter LJ was assessed in a GLP-compliant short-term toxicity to fish study, according to OECD guideline 203 and EU method C.1. Two experiments were performed. For the first experiment a stock emulsion containing 1000 mg/L in dilution water was prepared on each day of the test. This emulsion was used to prepare the test solution containing 100 mg/L. Three fish were exposed to the test item for 96 hours in a semi-static test system with a medium renewal every 24 hours. No mortality was observed, either in the treatment or the control. None of the fish showed any signs of morbidity at the end of the test. The pH and the oxygen value of the water were normal. The test item is poorly water soluble and an oily film was observed on the surface of the stock emulsion as well as on the treatment solution. Thus, the concentration of the test item in the treatment was not reproducible.

In the second experiment, for each medium renewal the “water-accommodated fraction” (WAF) was prepared by weighing of the nominal load 100 mg/L, adding the corresponding amount of dilution water and stirring slowly for 24 hours instead of shaking. The resulting solution was left to stand for 15 minutes, then the lower phase was taken for the test. Seven fish were exposed to the test item for 96 hours in a semi-static test system with medium renewal every 24 hours. No mortality was observed in the treatment and the control. None of the fish showed any signs of morbidity at the end of the test. The pH and the oxygen value of the water were normal. As no analytical method exists for the test item and because of the immediate hydrolysis of the test item, the hydrolysis product 2,2-Dimethyl-3-laureoyloxy-propanal should have initially been analysed. But this product is not stable as well. The soluble part is too little to be determined as TOC (as has been demonstrated in the respective studies “toxicity against alga and daphnia”). Therefore no analytical determination of the test item in the test solutions was possible and the biological results were based on the nominal concentrations.

The test item showed no mortality up to a nominal concentration of 100 mg/L. Therefore the 96 h LC 50 was determined to be greater than 100 mg/L and the 96 h NOEC was determined to be 100 mg/L.

Because of the immediate hydrolysis, no water solubility could be determined. The calculated value (following EPA-Calculation) is much smaller than 1 mg/L. The water solubility of the product of hydrolysis is below 1 mg/L. Therefore it can be stated that the tested concentration is definitely above the limit of water solubility and thus the “worst case” was tested.

Description of key information

Sika Hardener LJ was tested for acute toxicity to freshwater fish in a 96h-semi-static test according to EU method C.1. The test item showed no mortality up to a nominal concentration of 100 mg/L revealing a LC50 of greater than 100 mg/L and a NOEC of 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 100 mg/L

Additional information

Sika Hardener LJ was assessed in a short-term toxicity to fish study, according to OECD guideline 203 and EU method C.1. Young zebrafish were exposed to the test item in a semi-static test for 96 h at a nominal concentration of 100 mg/L. The test item showed no mortality up to a nominal concentration of 100 mg/L. Therefore the 96 h LC 50 was determined to be greater than 100 mg/L and the 96 h NOEC was determined to be 100 mg/L.