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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06. Feb. 2006 - 22. Feb. 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
During the limit test singular samples for analysis were taken from both the test concentration and the blank-control.
Sampling:
Frequency : at t= 0 h and t= 48 h.
Volume : 20 ml from the approximate centre of the test vessel
Storage : Samples were stored in a refrigerator until analysis.
Additionally, singular reserve samples of 20 ml were taken for possible analysis. If not used, these samples were stored in a refrigerator for possible analysis until delivery of the final report with a maximum of three months.
Vehicle:
no
Details on test solutions:
The standard test procedures required generation of test solutions, which should 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):
Daphnia magna
Details on test organisms:
Species : Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
Source : In-house laboratory culture with a known history
Reason for selection : This system has been selected as an internationally accepted invertebrate species.
Validity of batch : Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics : For the test selection of young daphnia with an age of < 24 hours, from parental daphnids of more than two weeks old
Breeding
Start of each batch : With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
Maximum age of the cultures : 4 weeks
Renewal of the cultures : After 7 days of cultivation half of the medium twice a week.
Temperature of medium : 18 - 22 °C
Feeding : Daily, a suspension of fresh water algae
Medium : M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency inCrustacea. An ultrastructural approach to antennal
damage in Daphnia magna Straus. Protoplasma 154, 25-33).
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
20 - 21 °C
pH:
7.9 - 8.0
Dissolved oxygen:
8.9 - 9.5
Nominal and measured concentrations:
100 mg/L nominal
97.2 - 101 mg/L measured
Details on test conditions:
FORMAMIDOPROPYLBETAINE : 100 mg/l, the regulatory limit concentration
Controls : Test medium without test sUbstance or other additives (blank-control)
Test duration : 48 hours
Test type : Static
Test vessels : 100 ml, all-glass
Medium : ISO
Number of daphnia : 20 per concentration
Loading : 5 per vessel containing 80 ml of test solution
Light : 16 hours photoperiod daily
Feeding : No feeding
Aeration : No aeration of the test solutions.
Introduction of daphnia : Within 1 hour after preparation of the test solutions.
Reference substance (positive control):
yes
Remarks:
reference test with potassium dichromate
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Results with reference substance (positive control):
The actual responses in this reference test with K2Cr207 are within the ranges of the expected responses at the different concentrations. Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at NOTOX.
The 24h-EC50 was 0.88 mg/I with a 95% confidence interval between 0.80 and 1.0 mg/l.
The 48h-EC50 was 0.61 mg/I with a 95% confidence interval between 0.55 and 0.71 mg/I.
The raw data from this study are kept in the NOTOX archives. The test described above was performed under GLP with a QA-check.

Acute immobilisation of daphnia after 24 and 48 hours in the limit test

Concentration Test substance1[mg/L]

Vessel number

Number Daphnia exposed

Response at 24 h

Response at 48 h

Number

Total %

Number

Total %

Blank-control

A

5

0

0

0

0

B

5

0

0

C

5

0

0 (1)

D

5

0

0

100

A

5

0

0

0

0

B

5

0

0

C

5

0

0

D

5

0

0

1Test substance IS FORMAMIDOPROPYLBETAINE

Numbers of daphnids trapped at the surface are between parenthesis. These organisms were re-immersed into the respective solutions before recording of mobility.

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present study FORMAMIDOPROPYLBETAINE did not induce acute immobilisation of Daphnia magna at 100 mg/I after 48 hours of exposure (NOEC). The 48h-EC50 was > 100 mg/I based on analytically confirmed nominal exposure concentrations.
Executive summary:

Acute Toxicity Study in Daphnia magna with FORMAMIDOPROPYLBETAINE.

The study procedures described in this report were based on the ISO International Standard 6341, 1996. In addition, the procedures were designed to meet the test methods and validity criteria of the EEC directive 92/69, Part C.2,1992 and the OECD guideline No. 202, 2004.

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. Twenty daphnids per concentration (in quadruplicate, five per replicate) were exposed to a nominal FORMAMIDOPROPYLBETAINE concentration of 100 mg/l and a blank-control. The total test period was 48 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 (96% of initial). Therefore, the NOEC and EC50-values were based on the nominal test concentration. The study met the acceptability criteria prescribed by the protocol and was considered valid. FORMAMIDOPROPYLBETAINE did not induce acute immobilisation of Daphnia magna at 100 mg/l after 48 hours of exposure (NOEC). The 48h-EC50 was >100 mg/l based on analytically confirmed nominal exposure concentrations.

Description of key information

Under the conditions of the present study FORMAMIDOPROPYLBETAINE did not induce acute immobilisation of Daphnia magna at 100 mg/I after 48 hours of exposure (NOEC). The 48h-EC50 was> 100 mg/I based on analytically confirmed nominal exposure concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

Acute Toxicity Study in Daphnia magna with FORMAMIDOPROPYLBETAINE.

The study procedures described in this report were based on the ISO International Standard 6341, 1996. In addition, the procedures were designed to meet the test methods and validity criteria of the EEC directive 92/69, Part C.2,1992 and the OECD guideline No. 202, 2004.

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. Twenty daphnids per concentration (in quadruplicate, five per replicate) were exposed to a nominal FORMAMIDOPROPYLBETAINE concentration of 100 mg/l and a blank-control. The total test period was 48 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 (96% of initial). Therefore, the NOEC and EC50-values were based on the nominal test concentration. The study met the acceptability criteria prescribed by the protocol and was considered valid. FORMAMIDOPROPYLBETAINE did not induce acute immobilisation of Daphnia magna at 100 mg/l after 48 hours of exposure (NOEC). The 48h-EC50 was >100 mg/l based on analytically confirmed nominal exposure concentrations.