Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 21 - 25, 1993
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP or analytical confirmation
Justification for type of information:
Please see attached Category Approach
Reason / purpose for cross-reference:
read-across source
equivalent or similar to guideline
EPA OTS 797.1400 (Fish Acute Toxicity Test)
not specified
GLP compliance:
as stated in protocol
Analytical monitoring:
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM- Common name: Rainbow Trout- Strain: - Source: SLI Lot #93A5- Age at study initiation (mean and range, SD): not mentioned- Length at study initiation (length definition, mean, range and SD): not mentioned- Weight at study initiation (mean and range, SD): not mentioned- Method of breeding: - Feeding during test - Food type: - Amount: not fed - Frequency: ACCLIMATION- Acclimation period: 14 day minimum- Acclimation conditions (same as test or not): same- Type and amount of food: dry commercial pelleted food, ad libitum - Feeding frequency: daily- Health during acclimation (any mortality observed): not mentionedQUARANTINE (wild caught)- Duration: - Health/mortality:
Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
36 mg/L
Test temperature:
12+/- 1 degree C
7.0 - 7.4
Dissolved oxygen:
78-92% of saturation
Nominal and measured concentrations:
0, 130, 220 360, 600 and 1000 mg active ingredient/liter (nominal)
Details on test conditions:
TEST SYSTEM- Test vessel: - Type (delete if not applicable): open - Material, size, headspace, fill volume: glass, 18.9 liter, 15 liter of test solution - Aeration: none- Type of flow-through (e.g. peristaltic or proportional diluter): static- Renewal rate of test solution (frequency/flow rate):- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 2- No. of vessels per vehicle control (replicates): N/A- Biomass loading rate: 0.29 grams per liter of test solutionTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: well water- Total organic carbon: 0.82 - 1.5 mg/L- Particulate matter: not mentioned- Metals: below limits of quantitation except 0.02 mg/L manganese and 2.3 mg/L magnesium- Pesticides: all less than limits of quantitation- Chlorine:- Alkalinity: 26 mg/L as CaC03- Ca/mg ratio: 3:1- Conductivity: 100 micro mhos/cm- Culture medium different from test medium: same- Intervals of water quality measurement: not mentionedOTHER TEST CONDITIONS- Adjustment of pH:- Photoperiod: 16 hrs light - 8 hrs darkness- Light intensity: 70 footcandles at surfaceEFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and observations of the fish twice dailyTEST CONCENTRATIONS- Spacing factor for test concentrations: <2X- Justification for using less concentrations than requested by guideline: - Range finding study - Test concentrations: 0.10 to 100 mg active ingredient per liter - Results used to determine the conditions for the definitive study: no mortality at 100 mg/L
Reference substance (positive control):
not specified
Key result
96 h
Dose descriptor:
Effect conc.:
> 1 000 mg/L
Nominal / measured:
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: no mortality observed in any test chambers
Details on results:
- Behavioural abnormalities: no loss of equilibrium observed- Observations on body length and weight:- Other biological observations:- Mortality of control: none- Other adverse effects control: none- Abnormal responses:- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:- Effect concentrations exceeding solubility of substance in test medium:
Results with reference substance (positive control):
no reference substance used
Validity criteria fulfilled:
Test material not acutley toxic to rainbow trout at up to 1000 mg/L active ingredient

Description of key information

The key study is a 1993 USEPA Guideline study (EPA-OTS 5797.1400) Fish Acute Toxicity Test using Oncorhynchus mykiss with the test substance sodium xylenesulphonate.   The 96-hour LC50 value was greater than the highest test concentration at >1000 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1 000 mg/L

Additional information

The key study is a 1993 USEPA Guideline study (EPA-OTS 5797.1400) Fish Acute Toxicity Test using Oncorhynchus mykiss and the test substance sodium xylenesulphonate. The study is well documented but was not conducted under GLP compliance. Rainbow trout were exposed to the test substance for 96 hours in freshwater under static conditions. Chemical analysis was not performed. The nominal 96-hour LC50 was greater than the highest test concentration at >1000 mg/L (active ingredient). No deaths or abnormal behavior were observed in the test at any of the 5 concentrations.

The supporting study tested calcium xylenesulphonate and was conducted to GLP compliance in accordance with the USEPA Guideline (EPA-OTS 5797.1400). The measured 96-hour LC50 for rainbow trout in this flow-through study was 1580 mg/L. The NOEC was 824 mg/L based on behavioural abnormalities (e.g., loss of equilibrium) at the 1580 mg/L exposure level.

Categories Display