Glycine, N-methyl-, N-coco acyl derivs.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A defined amount of the test substance (stock solution concentration = 500 mg/L) was weighed into a measuring flask and the total volume was filled up with dilution water. The test bottles were conditioned about 15 min before the test was started.
- Differential loading: yes
- Controls: yes, dilution water served as negative control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Length at study initiation: 2.0 cm (average length)

ACCLIMATION
- Acclimation period: at least 14 d
- Feeding frequency during acclimation: daily

FEEDING DURING TEST
- Frequency: no feeding during the test

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

0 h: 18.2 (control), 18.2 - 18.3 °C (treatments)
96 h: 18.2 (control), 18.1 - 18.2 °C (treatments)

pH:

At 0 h: 7.8 (control), 7.6 - 7.8 (test solutions)
At 96 h: 7.7 (control), 7.7 - 7.8 (test solutions)

Dissolved oxygen:

At 0 h: 8.1 mg/L (control), 7.4 - 7.9 mg/L (test solutions)
At 96 h: 8.1 mg/L (control), 6.9 - 7.5 mg/L (test solutions), corresponding to 86.5% of the air saturation

Nominal and measured concentrations:

nominal: control, 1.0, 2.0, 5.0, 10.0 and 20.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers
- fill volume: 7 L
- Aeration: yes, constantly
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: chlorine-free drinking water
- Hardness (dilution water): 37.4 mg/L Ca-content (between 4 - 100 mg/L)
- Copper content: < 0.01 mg/L
- Chlorine: none
- Culture medium different from test medium: no
- Intervals of water quality measurement: PH values, O2 concentration and temperature were measured at 0, 24, 48, 72 and 96 h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 h light-dark cycle
- Light intensity: indirect day-similar light

EFFECT PARAMETERS MEASURED:
The fish were inspected at 24, 48, 72 and 96 h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 - 2.5
- Range finding study: no

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.16 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC10

Effect conc.:

1.76 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: ??

Reported statistics and error estimates:

The statistical evaluation is based on a Probit analysis. The calculation of the Probit values with the date after 24 to 96 h bases was performed with with computer program "Dosis 50". In this program the experimentally determined percentages in the range from 1 - 99% can be used for the calculation of the Probit values and so for the evaluation of the effective concentrations. For the experimental values of 0% and 100% there are no Probit values defined. For the calculation of the Probit values of these percentages the percentages 1% and 99% were used.

Sublethal observations / clinical signs:

The highest tested concentration of test substance producing no mortality under test conditions after 96 h was 1.0 mg/L.

The lowest tested concentration of test substance producing 100% mortality under test conditions after 96 h was 10.0 mg/L.

Table 1. Mortality in 24 h intervals.

Concentration of test substance [mg/L]	Dead fish [%] after 24 h	Dead fish [%] after 48 h	Dead fish [%] after 72 h	Dead fish [%] after 96 h
20.0	100	100	100	100
10.0	71	100	100	100
5.0	29	71	71	86
2.0	14	14	14	14
1.0	0	0	0	0
control	0	0	0	0

 

Validity criteria fulfilled:

yes

Remarks:

No analytical measurement was conducted. Thus, the deviation from the nominal concentration could not be checked.

Description of key information

LC50 (96 h) = 3.16 mg/L test substance (nominal, Danio rerio, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

3.16 mg/L

Additional information

One GLP-study according to OECD 203 investigating the short-term toxicity of Glycine, N-methyl-, N-coco acyl derivatives (CAS 68411-97-2) to freshwater fish is available. The test organism Danio rerio was exposed to five nominal concentrations of the test substance ranging from 1.0 - 20.0 mg/L (1, 2, 5, 10 and 20 mg/L) in controlled conditions for 96 h. No analytical measurement was conducted. Mortality was recorded at daily intervals and was compared to the negative control at test termination. After 96 h mortality was observed at concentrations ≥ 2.0 mg/L. The derived 96 h nominal LC50 value was 3.16 mg/L.