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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:
06. Feb. 2006 - 24. Feb. 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/I , the regulatory limit concentration.
- Sampling method: 20 ml from the approximate centre of the test vessels at t= 0 h and t= 96 h.
- Sample storage conditions before analysis: Samples taken at t=o and t=24 h were stored in a refrigerator until analysis. Samples taken at t=96 h were analysed on the day of sampling.
Vehicle:
no
Details on test solutions:
The standard test procedures required generation of test solutions that contain completely dissolved test substance concentrations or stable and homogeneous mixtures or dispersions. The batch of FORMAMIDOPROPYLBETAINE tested was a clear yellowish liquid with a purity of 40.1 % and completely soluble in test medium at the concentrations tested.
Preparation of test solutions started with a solution of 100 mg/I applying 10-14 minutes of magnetic stirring to accelerate the dissolving of the test substance in the test medium. The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the 100 mg/I concentration in test medium. The final test solutions were all clear and colourless.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Species : Carp (Cyprinus carpio, Teleostei, Cyprinidae), Linnaeus, 1758
Source : Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, the Netherlands.
Mean length : Range-finding test 2.8 ± 0.2 cm, Limit test: 2.6 ± 0.2 cm
Mean weight : Range-finding test: 0.58 ± 0.14 g, Limit test: 0.50 ± 0.11 g
Characteristics : F1 from a single parent-pair bred in UV-treated water.
Reason for selection : This system has been selected as an internationally accepted species.
Total fish used : 26
Quarantine/ Acclimatisation : At least 12 days after delivery.
Medium : ISO-medium, formulated using Milli-Ro water (tapwater purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA)
Measurements : pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: every day. In addition, pH and temperature were measured before transferring the fish to the test system.
Water quality parameters : Were kept within the optimum limits for the respective fish species.
Feeding : Daily with pelleted fish food and/or artemia until 24 hours before the test is started.
Validity of batch : In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
250 mg CaC03 per litre
Test temperature:
20.3 - 20.8 °C
pH:
7.4 - 7.9
Dissolved oxygen:
6.4 - 8.9
Nominal and measured concentrations:
Nominal concentration: 100 mg/L,
Measured concentration: 101 mg/L at t = 0h and t = 96 h.
Details on test conditions:
Test duration : 96 hours
Test type : Static
T est vessels : 10 litres , all-glass, containing 9 litres of test solution
Test medium : ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilised. After aeration the hardness was 250 mg CaC03 per litre and the pH was 8.0.
Number of fish : 7 fish per concentration and control
Loading : 0.39 g fish/litre, i.e. 7 fish per 9 litres of test medium
Illumination : 16 hours photoperiod daily
Aeration : The test media were not aerated during the test.
Feeding : No feeding from 24 hours prior to the test and during the total test period.
Introduction of fish : Within 35 minutes after preparation of the test media from a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 0.5 unit and 0.5°C.
Euthanasia : At the end of the test the surviving fish were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water.
Reference substance (positive control):
yes
Remarks:
independent reference test with pentachlorophenol
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
No mortality and no clinicla signs were observed.
Results with reference substance (positive control):
Under the conditions of the present test PCP induced no lethal effects in carp at 0.10 mg/l. The 96h-LC50 for carp exposed to PCP was 0.15 mg/l (95 % confidence interval between 0.10 and 0.22 mg/l) and was already reached within 48 hours of exposure. The range of the 96h-LC50 for carp is generally between 0.10 and 0.46 mg/l based on historical data of reference tests performed approximately every 3 months from April 1988 until the end
2000, and annually since then. Hence, the sensitivity of carp originating from the present batch for PCP falls within the range of sensitivities generally observed during the past years.
Sublethal observations / clinical signs:

Incidence of mortality and total mortality during the limit test

Concentration Test substance [mg/L]

Initial number of fish

Cumulative mortality

Total mortality [%]

2¼ h

24 h

48 h

72 h

96 h

Blank-control

7

0

0

0

0

0

0

100

7

0

0

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present test FORMAMIDOPROPYLBETAINE induced no visible effects in carp at 100 mg/I (NOEC). The 96h-LC50 was> 100 mg/I based on analytically confirmed nominal concentrations.
Executive summary:

96-Hour Acute Toxicity Study in Carp with FORMAMIDOPROPYLBETAINE.

The study procedure described in this report was based on the ISO International Standard 7346-1: Static method, 1996. In addition, the procedures were designed to meet the test methods and validity criteria of the EEC directive 92/69, Part C.1 ,1992 and the OECD guideline No. 203,1992.

The batch of FORMAMIDOPROPYLBETAINE tested was a clear yellowish liquid with a purity of 40.1%. The water solubility of FORMAMIDOPROPYLBETAINE at 20.2 ± 0.6°C was determined to be > 2160 g/l (NOTOX Project 453915). Based on the results of a preceding range-finding test, a limit test was performed. Seven fish per concentration were exposed to a nominal FORMAMIDOPROPYLBETAINE concentration of 100 mg/l and a blank-control. The total test period was 96 hours and samples for confirmation of actual exposure concentrations were taken at the start and the end of the test period. Analysis of the sample taken at the start of the test showed that the test concentration was in agreement with nominal (101 %) and remained stable during the test period (100% of initial). Therefore, the NOEC and LC50-values were based on the nominal test concentration. The study met the acceptability criteria prescribed by the protocol and was considered valid. FORMAMIDOPROPYLBETAINE induced no visible effects in carp at 100 mgll (NOEC). The 96h-LC50 was >100 mg/l based on analytically confirmed nominal concentrations.

Description of key information

Under the conditions of the present test FORMAMIDOPROPYLBETAINE induced no visible effects in carp at 100 mg/I (NOEC). The 96h-LC50 was> 100 mg/I based on analytically confirmed nominal concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

96-Hour Acute Toxicity Study in Carp with FORMAMIDOPROPYLBETAINE.

The study procedure described in this report was based on the ISO International Standard 7346-1: Static method, 1996. In addition, the procedures were designed to meet the test methods and validity criteria of the EEC directive 92/69, Part C.1 ,1992 and the OECD guideline No. 203,1992.

The batch of FORMAMIDOPROPYLBETAINE tested was a clear yellowish liquid with a purity of 40.1%. The water solubility of FORMAMIDOPROPYLBETAINE at 20.2 ± 0.6°C was determined to be > 2160 g/l (NOTOX Project 453915). Based on the results of a preceding range-finding test, a limit test was performed. Seven fish per concentration were exposed to a nominal FORMAMIDOPROPYLBETAINE concentration of 100 mg/l and a blank-control. The total test period was 96 hours and samples for confirmation of actual exposure concentrations were taken at the start and the end of the test period. Analysis of the sample taken at the start of the test showed that the test concentration was in agreement with nominal (101 %) and remained stable during the test period (100% of initial). Therefore, the NOEC and LC50-values were based on the nominal test concentration. The study met the acceptability criteria prescribed by the protocol and was considered valid. FORMAMIDOPROPYLBETAINE induced no visible effects in carp at 100 mgll (NOEC). The 96h-LC50 was >100 mg/l based on analytically confirmed nominal concentrations.