Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
fish, juvenile growth test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to generally vaiid procedures and according to GLP guidelines. All parameters described are closely related or comparable to guideline methods.
Qualifier:
according to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all
- Sampling method: sampled from middle layer of each test vessel
- Sample storage conditions before analysis: none
Details on test solutions:
Nominal concentrations of 100, 50.0, 25.0, 12.5 or 6.25mg/L and laboratory water control were tested. Solubilizer was not used. Concentrations of the test substance were kept close to the nominal concentrations throughout the 14-day test (99 to 106 %).
Test organisms (species):
Oryzias latipes
Details on test organisms:
10 fish per exposure or control group
TEST ORGANISM
- Common name:Medaka
- Strain:Oryzias latipes
- Source: Nakashima Fish Farm
- Age at study initiation (mean and range, SD):
- Length at study initiation :1.9 cm (1.8 to 2.0 cm),
- Weight at study initiation:0.095 g (0.082 to 0.11 g)
- Feeding during test Yes
- Food type:TetraMin (TetraWerke)
- Amount:2% of the fish weight
- Frequency: daily

ACCLIMATION
- Acclimation period: more than 12 days
- Acclimation conditions: same as test
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
14 d
Test temperature:
23.8 to 24.2°C.
pH:
7.0 to 7.5
Dissolved oxygen:
7.6 to 8.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 1.8 L/test vessel
- Type (delete if not applicable): open / closed
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): 25 ml/min
- No. of organisms per vessel:1
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates):
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
ca. 50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
length
Remarks:
in young fish
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
in young fish
Details on results:
- Type of and number with morphological abnormalities: none
- Type of and number with behavioural abnormalities: none
- Other biological observations: light body color in one fish at 100 mg/l
- Incidents in the course of the test which might have influenced the results: none
Validity criteria fulfilled:
yes
Conclusions:
For the freshwater fish Oryzias latipes, the 14-day LC50 (mortality in young fish) and NOEC (length in young fish) are calculated to be >100 mg MEKO/L and 50 mg MEKO/L, respectively.

Description of key information

The 14-d NOEC of 50 mg/L in Oryzias latipes will be used in the assessment.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
50 mg/L

Additional information

One long-term toxicity study with freshwater fish, Oryzias latipes, is available for MEKO. The test is a flow-through GLP-compliant, OECD Guideline 204 study with analytical monitoring (Kurume Laboratory, 1998b). The 14-d NOEC is >100 mg/L based on mortality and ca. 50 mg/L based on length in young fish.