Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance study conducted under GLPs

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: clear liquid
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point:
- Boiling point:
- Vapour pressure:
- Water solubility (under test conditions):
- Henry's law constant:
- log Pow:
- pKa:
- Stability in water:
- Stability in light:
- pH dependance on stability:

OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: Not readily biodegradable
- Other:

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The concentrations of methyl propyl ketoxime in the test solution were measured at 0 and 96 hours using a high performance liquid chromatography method.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
test material weighed, added to water in beaker, stirred vigourously for 10 minutes. (concnentration 100 mg/l)

Final solutions were clear and colorless.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name:rainbow trout
- Strain: O. mykiss
- Source: Houghton Springs Fish Farm, Winterbourne Houghton, Blandford Forum, Dorset DT11, 0PD
- Length at study initiation : 44 - 52 mm, mean 49 mm
- Weight at study initiation : range 1.10 – 1.96 g, mean 1.55 g
- Feeding during test: none


ACCLIMATION
- Acclimation period: at least 7 days
- Acclimation conditions: same as test
- Type and amount of food: proprietary brand of high protein pelleted fish food
- Feeding frequency:daily
- Health during acclimation : no mortality observed

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
na

Test conditions

Hardness:
46.3 mg/l CaCO3
Test temperature:
14.5 - 15.2 degrees Celcius
pH:
7.2 - 7.57
Dissolved oxygen:
73 - 92%
Salinity:
NA
Nominal and measured concentrations:
nominal 100 mg/l, measured 102 mg/l at 0 hour and 103 mg/l at 96 hours
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume:
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel:
- No. of vessels per concentration (replicates):
- 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:tap water coarsely filtered to remove particulate material, passed through activated carbon and dechlorinated using sodium thiosulphate. Salts ifrequired to maintain minimum hardness levels. Treated water passed through ultraviolet steriliser and filtered to 10 µm
- Total organic carbon: 2.35 mg/l dissolved organic carbon
- Particulate matter: < 3 mg/l as suspended solids
- Metals: not reported
- Pesticides: < 0.01 ug/l
- Chlorine: < 2 u/l as Cl2 (free and total)
- Alkalinity:26.4 m/l CaCO3
- Ca/mg ratio: not reported
- Conductivity: 213 us/cm
- Culture medium different from test medium:
- Intervals of water quality measurement: daily to quarterly depending on parameter

OTHER TEST CONDITIONS
- Adjustment of pH:Not needed

TEST CONCENTRATIONS
- Spacing factor for test concentrations: NA limit test
- Range finding study: yes
- Test concentrations: 10 and 100 mg/l
- Results used to determine the conditions for the definitive study: 1 dead at 10 mg/l, none at 100 mg/l.
Reference substance (positive control):
not required

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Basis for effect:
other: mortality and signs of toxicity
Details on results:
- Behavioural abnormalities: none observed
- Observations on body length and weight: none observed
- Other biological observations: none observed
- Mortality of control: none observed
- Other adverse effects control: none observed
- Abnormal responses: none observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none observed
- Effect concentrations exceeding solubility of substance in test medium: none observed
Results with reference substance (positive control):
NA
Reported statistics and error estimates:
NA

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
dissolved oxygen > 60%, mortality < 10% in controls
Conclusions:
No mortality or signs of toxicity were observed in raindbow trout exposed to 100 mg/l (nominal; 102 mg/l measured) test substance for 96 hours.