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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1996-03-21 to 1996-04-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Although a guideline study (OECD 203 & EU Method C.1.) conducted according to the principles of Good Laboratory Practice, the purity, batch number and expiry date of the test substance was not supplied and its stability under the test conditions was not determined.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
The total hardness of this medium slightly exceeded that recommended by the test guidelines (maximum value, 250 mg/L as CaCO3), this was not considered to be significant or to have affected the integrity ofthe test.
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Substance type: technical material
- Physical state: a fine cream-coloured cohesive powder
- Storage condition of test material: at ambient temperature
- Other: Test concentrations quoted in the report refer to the test material as received; no allowance has been made for a purity of less than 100%
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Prepared from concentrated aqueous stocks in which the appropriate weights of test material, mixed with acetone, had been added to dilution water (2L); these concentrated stocks were treated by ultrasound for 30 minutes before being diluted to a volume of 20 Litres. Each 20 Litre batch of medium was then stirred for approx. 4 hours before being left overnight in the test area to equilibriate. Approximately fourteen litres of the medium were removed mid vessel and placed into a test vessel.
- Controls: dilution water alone or dilution water containing acetone at the same level as the test solutions
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 0.1ml/Litre

Additional comment on medium preparation (information not presented in test report):
The test substance was multi-component and poorly soluble in water so the test media were prepared using techniques based on those employed for generating water accommodated fractions (WAFs). An auxiliary solvent was also used to aid dissolution and dispersion of the test substance. The physical methods employed were ultrasound and prolonged vigorous stirring. The formulation methods employed were designed to maximise the concentrations of the test substance in solution and therefore bioavailable to the test organisms. To avoid exposing the test organisms to large amounts of insoluble test material, the media used in the fish and Daphnia tests were left to equilibrate overnight before use and then the aqueous fraction was removed mid-vessel and used to fill the test vessels; for the algal study, the insoluble fraction of the test substance was removed by centrifugation. Although a concentrated stock was prepared for the fish test (to facilitate ultrasound treatment), the entire contents of the stock prepared for each batch of test medium was diluted to the required final volume, so the composition of the test mixture would not have been altered. Although the use of an auxiliary solvent may have an effect on the proportions of the different components dissolved, the amount used (0.1 ml/L) was very small and its impact is thought to have been negligible.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Not stated
- Source: derived from ova and milt supplied by Fish Network Ltd., Devon, UK.
- Age at study initiation (mean and range, SD): approx 5 - 6 weeks
- Length at study initiation (length definition, mean, range and SD): 4.3 cms (a mean fork length assessed from a sample of ten fish)
- Weight at study initiation (mean and range, SD): 0.9 grammes (a mean weight assessed from a sample of ten fish)
- Method of breeding: ova and milt supplied from source (see above) and fertilised at Huntingdon Life Sciences Laboratories.
- Feeding during test
Not fed during the definitive test


ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): in an aerated supply of dilution water under flow-through conditions until removed for use in tests
- Type and amount of food: proprietary trout pellets (Trouw (UK) Ltd, Nutra Trout Fry 02), amount equivalent to between 1 and 4% of the total net-weight of the fish in the holding tank
- Feeding frequency: daily up to 24 hours before the start of the definitive test
- Health during acclimation (any mortality observed): mortality of less than 1%
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
Ranged from 236 to 252 mg/L as CaCO3
Test temperature:
13.4 - 14.6 °C
pH:
7.7 - 8.5
Dissolved oxygen:
76 - 101 %ASV
Nominal and measured concentrations:
Nominal: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: all glass aquaria (with a total capacity of 15 Litres) with a depth of the test solutions in each was 19cm
- Aeration: by a Pasteur pipette connected to an oil free supply of compressed air
- Renewal rate of test solution (frequency/flow rate): at 24, 48, 72 and 96 hours.
- 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): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: previously filtered (through activated carbon to remove chlorine) tap water blended with tap water that had
been softened and treated by reverse osmosis to achieve hardness in the range 200 -250 mg/L as CaCO3. This water was held in an intermediate
tank where it was equilibrated to the test temperature and gently aerated before being supplied to the holding and test areas.
- Total organic carbon: <1-1.2
- Conductivity: 413-436 μS/cm
- Culture medium different from test medium: Same
- Intervals of water quality measurement: at the start of the test and after 24 and 96 hours.


OTHER TEST CONDITIONS
- Adjustment of pH: Not adjusted or controlled
- Photoperiod: 16 hours light/8 hours dark
- Light intensity: Not reported, but supplied by overhead fluorescent tubes. Dawn and dusk were simulated by periods of subdued lighting at the beginning and end of each light phase.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortalities and treatment related effects every 24 hours


TEST CONCENTRATIONS
- Range finding study
- Test concentrations: control, 1, 10 and 100 mg/Litre
- Results used to determine the conditions for the definitive study: yes, the results of the rangefinding test indicated that the 96-hour LC50 of test item was > 1 00 mg/L (the nominal exposure concentration used to prepare the initial test mixture), thus 100 mg/Litre was chosen for the definitive study.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
as supplied
Basis for effect:
mortality (fish)
Details on results:
No mortalities or adverse effects were noted.
The batches of test medium were white (hazy), homogenous dispersions.
No concentration-related changes in test environment and water quality parameters were observed.
Validity criteria fulfilled:
yes
Conclusions:
No mortalities or treament-related effects were observed during the study. It was concluded that an aqueous mixture of test item, derived from a preparation at an initial nominal concentration of 100 mg/L, was not acutely toxic to rainbow trout.
Executive summary:

A study was conducted to investigate the acute toxicity of test item to rainbow trout based on OECD Procedure 203 and the Annex to EC Directive 92/69/EEC, Part C1.

Two groups of ten fish were exposed to a limit test to an equilibrated aqueous dispersion of test item prepared at an initial nominal concentration of 100 mg/Litre, selected following a rangefinding test in which no toxicity was seen. The test medium was prepared in duplicate by adding the test material, mixed with acetone, to water; to assist dispersion, sonication followed by four hours of vigorous stirring were employed. Each batch of medium was then left overnight to allow undisssolved material to settle out of suspension before fourteen litres of medium were removed mid-vessel and placed in a test vessel. Control groups of fish were placed into dilution water alone or dilution water containing acetone at the same level as in the test medium (0.1mL/L). The control and and test media were renewed every 24 hours.

There were no treatment-related effects or mortalities observed during the test. Therefore, it was concluded that an aqueous mixture of the test item derived from a preparation of an initial concentration of 100 mg/L, was not acutely toxic to raibow trout.

Description of key information

A study was conducted to investigate the acute toxicity of test item to rainbow trout based on OECD Procedure 203 and the Annex to EC Directive 92/69/EEC, Part C1.

There were no treatment-related effects or mortalities observed during the test. Therefore, it was concluded that an aqueous mixture of the test item derived from a preparation of an initial concentration of 100 mg/L, was not acutely toxic to raibow trout.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

The test item aqueous mixture derived from a preparation of an initial concentration of 100 mg/L, was not acutely toxic to raibow trout.