Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

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 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 before test
- Acclimation conditions: day/night change, circulation filters, 21 °C
- Feeding frequency during acclimation: daily

FEEDING DURING TEST
- Frequency: no feeding during test
Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
0 h: 19.5 (control), 19.4 - 19.6 °C (test solutions)
96 h: 20.2 (control), 19.6 - 19.9 °C (test solutions)
pH:
At 0 h: 7.9 (control), 8.0 (test solutions)
At 96 h: 7.9 (control), 7.6 - 7.9 (test solutions)
Dissolved oxygen:
At 0 h: 7.0 mg/L (control), 6.8 - 7.8 mg/L (test solutions)
At 96 h: 6.0 mg/L (control), 5.5 - 6.9 mg/L (test solutions), corresponding to 66% of the air saturation
Nominal and measured concentrations:
nominal: control, 2.5, 5, 10, 25, 50 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: Fill volume: 7 L
- Aeration: yes, continuously
- 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: 37.4 mg/L Ca
- Metals: Copper content: < 0.01 mg/L
- Chlorine: none
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24 h. PH values and O2 concentration 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
- Range finding study: no
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
14.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: 0%
- Any observations that might cause a difference between measured and nominal values: no
Reported statistics and error estimates:
The statistical evaluation was based on a Probit analysis. The calculation of the Probit values with the date after 24 to 96 h was performed with the computer program "Dosis 50". In this program the experimentally determined values ranging from 1 - 99% can be used for the calculation of the Probit values and the evaluation of the effective concentrations. For the experimentally determined percentages of 5 and 100% no probit values are defined. Therefore, the values for 1% and 99% were used to calculate the probit values of these percentages, respectively.
Sublethal observations / clinical signs:

The highest tested concentration of test substance producing no mortality under test conditions after 96 h was 2.5 mg/L.

The lowest tested concentration of test substance producing 100% mortality under test conditions after 96 h was 50 mg/L.

Table 1. Mortality in 24 h intervals.

Concentration of test substance [mg/L]

Mortality [%] after 24 h

Mortality [%] after 48 h

Mortality [%] after 72 h

Mortality [%] after 96 h

100

100

100

100

100

50

86

100

100

100

25

29

57

71

71

10

14

14

29

29

5.0

0

0

14

14

2.5

0

0

0

0

control

0

0

0

0

 

Description of key information

LC50 (96 h) = 14.4 mg/L (nominal, Danio rerio, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
14.4 mg/L

Additional information

One GLP-study according to OECD 203 investigating the short-term toxicity of Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) to freshwater fish is available. The test organism Danio rerio was exposed to six nominal test concentrations ranging from 2.5 - 100 mg/L (2.5, 5, 10, 25, 50 and 100 mg/L) in controlled conditions for 96 h. No analytical measurement was conducted. Mortality was recorded in daily intervals and was compared to the negative control at test termination. After 96 h mortality was observed at concentrations ≥ 5.0 mg/L. The derived nominal LC50 value after 96 h was 14.4 mg/L.