N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine

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:

from 2014-06-04 to 2014-06-30

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:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: For determination of the test item concentration five replicate samples were taken from the test concentration and three from the control at the start and at the end of the test.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Mechanical dispersion. An amount of 0.3 g test item was dissolved in 3000 mL dilution water (ISO medium) using approximately 1 hour shaking in order to obtain the concentration of 100 mg/L.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Brachydanio rerio
- Source: Black Molly Bt. 8200 Veszprém, Jutasi út 29
- Age at study initiation: juveniles
- Length at study initiation: 2 ± 1 cm
- Weight at study initiation: measured weight of 10 fish: control: 1.913 g, 100 mg/L: 2.004 g
- Feeding during study: none

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions: same as test
- Type and amount of food: Fish were fed with appropriate, commercial diet for fish at least three times per week until one day before the test start.
- Health during acclimation: No mortality observed.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

none

Hardness:

249 mg/L (as CaCO3)

Test temperature:

22.2 – 22.8 ° C

pH:

7.11 – 8.41

Dissolved oxygen:

75.6 – 95.4 %

Salinity:

not applicable

Nominal and measured concentrations:

nominal: 100 mg/L, the measured concentrations varied between 99 and 104 % of the nominal concentration.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquariums with 3 Litre test liquid.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: did not exceed 1 g fish/L


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark

EFFECT PARAMETERS MEASURED:
The fish were observed at approximately 3, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Toxic effects were not observed during the preliminary test therefore a limit test was carried out with one treatment group at a concentration of 100 mg/L (limit concentration) and a concurrent control.
- Test concentrations in range finding study: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no toxic effects observed

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No sub-lethal effects were observed.
- Mortality of control: No mortality occurred in the control.
- Other adverse effects control: No adverse effects observed.

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of this study, the test item SIKA Hardener MI (SIKA Härter MI) had no toxic effect at the limit concentration of 100 mg/L on Zebrafish. Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L.

Executive summary:

In an acute Toxicity Test of SIKA Hardener MI (SIKA Härter MI) on Zebrafish (Brachydanio rerio) conducted according to OECD guideline 203 (1992), EU method C. 1 (2008) and OPPTS 850.1075 (1996), the acute toxicity of the test item on fish was evaluated. A limit test was performed in which the test animals were exposed to aqueous test media containing the test item for 96 hours at one concentration (100 mg/L) plus a control. Based on the results of an analytical method validation the concentration of the test item was expected to remain within 80 - 120 % of the nominal over the testing period, therefore, the experiment was carried out under static conditions. The measured test item concentration remained within ± 20 % of the nominal concentrations over the test period of 96 hours; therefore, the biological results are based on the nominal concentration. Mortality and any sub-lethal effects were not observed during the 96-h exposure period neither in the treated nor in the control group. Accordingly, the 96-h NOEC was determined to be 100 mg/L and the LOEC and the LC50 values were determined to be higher than 100 mg/L.

Description of key information

In a 96-hour acute toxicity study on fish the LC50 value was determined to be greater than 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

In an acute Toxicity Test of Sika Hardener MI (Sika Härter MI) on Zebrafish (Brachydanio rerio) conducted according to OECD guideline 203 (1992), EU method C. 1 (2008) and OPPTS 850.1075 (1996), the acute toxicity of the test item on fish was evaluated. A limit test was performed in which the test animals were exposed to aqueous test media containing the test item for 96 hours at one concentration (100 mg/L) plus a control. Based on the results of an analytical method validation the concentration of the test item was expected to remain within 80 - 120 % of the nominal over the testing period, therefore, the experiment was carried out under static conditions. The measured test item concentration remained within ± 20 % of the nominal concentrations over the test period of 96 hours; therefore, the biological results are based on the nominal concentration. Mortality and any sub-lethal effects were not observed during the 96-h exposure period neither in the treated nor in the control group. Accordingly, the 96-h NOEC was determined to be 100 mg/L and the LOEC and the LC50 values were determined to be higher than 100 mg/L.