Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 30, 2012 to February 03, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

1 but the study integrity was not adversely affected by this deviation

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)

GLP compliance:

yes

Specific details on test material used for the study:

The test substance was a clear green to brown highly viscous liquid with unknown purity

Analytical monitoring:

yes

Details on sampling:

Determination of the concentrations.
Samples for possible analysis were taken from all test concentrations and the control according to the schedule below. The method of analysis is described in the Analytical Report (APPENDIX 2) (Oudhoff, 2012).
Frequency: at t=0 h and t=96 h. Volume: 3 mL from the approximate centre of the test vessels. Storage: samples were stored in a freezer until analysis.

Vehicle:

yes

Details on test solutions:

A combined limit/range-finding test was performed. Preparation of test solutions started with individually prepared loading rates of 1.0, 10 and 100 mg/L applying a 1-hour period of magnetic stirring followed by a 0.5-hour settlement period. The clear and colourless Water Accommodated Fractions (WAFs) were subsequently siphoned and used as test solutions.

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 length1 2.4 ± 0.2 cm
Mean weight1 0.40 ± 0.09 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: 20

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

180 mg CaCO3 per litre

Test temperature:

22°C

pH:

7.7 ± 0.3

Dissolved oxygen:

at least 60% of the air saturation value

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

Since the measured concentrations deviated by more than 20% from nominal, results were based on the average exposure concentration.

Details on test conditions:

Test vessels: control and the highest concentration: 10 litres, all-glass, containing 9 litres of test solution and lower concentrations: 3.5 litres, all-glass, containing 3 litres of test solution
Test medium: Adjusted ISO medium
Number of fish: control and the highest concentration: 7 per group and lower concentrations: 3 per group
Loading: control and the highest concentration: 0.31 g fish/litre, i.e. 7 fish per 9 litres of test medium and lower concentrations: 0.40 g fish/litre, i.e. 3 fish per 3 litres of test medium
Illumination: 16 hours photoperiod daily
Aeration: introduced after 72 hours of exposure
Feeding: no feeding from 72 hours prior to the test and during the total test period
Introduction of fish: within 10 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:

pentachlorophenol

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.11 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: This is equivalent to 100 mg/L (nominal concentration)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.11 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: This is equivalent to 100 mg/L (nominal concentration)

Details on results:

The actual concentration in the sample taken from the WAF prepared at 100 mg/l was 0.155 mg/L at the start of the test. The measured concentration dropped to 0.079 mg/L (51% of initial, note that this value was extrapolated and is only indicative). Based on these results the average exposure concentration was calculated to be 0.11 mg/L.
The test substance induced no mortality or clinical effects in carp at an average exposure concentration of 0.11 mg/l (NOEC).

Results with reference substance (positive control):

Under the conditions of the present test with carp exposed to PCP, the 96h-LC50 was 0.25 mg/L based on nominal concentrations, with a 95% confidence interval between 0.20 and 0.41 mg/L. This effect was already reached within 24 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 of 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.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96h LC50 and NOEC for carp (Cyprinus carpio) were determined to be: > 0.11 mg/L and 0.11 mg/L, respectively.

Executive summary:

A study was conducted to determine the short-term toxicity of the test substance to fish according to OECD Guideline 203, EU Method C.1 and ISO 7346 -1. Carp (Cyprinus carpio) were exposed to water accomodated fractions (WAFs) prepared at concentrations of 0 (control), 1.0, 10, 100 mg/L under static conditions. The total exposure period was 96 h and samples for analytical confirmation of actual exposure concentrations were taken at the start and at the end of the test at the concentration of 100 mg/L. Mortality and other effects were recorded at 2, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from Day 0 and every morning from Day 1, observations for any dead or severely distressed fish were realized. The actual concentration in the sample taken from the WAF prepared at 100 mg/L was 0.155 mg/L at test start, dropping to 0.079 mg/L by test end (51% of initial – note that this value was extrapolated and is therefore only indicative). Based on these results, the average exposure concentration was calculated to be 0.11 mg/L. Under the study conditions, the 96 h LC50 and NOEC for carp were determined to be > 0.11 and 0.11 mg/L, respectively (Tobor-Kaplon, 2012).

Description of key information

The 96 h LC50 for carp was determined to be > 0.11 mg/L (measured; corresponding to nominal concentration of 100 mg/L).

Additional information

A study was conducted to determine the short-term toxicity of the test substance to fish according to OECD Guideline 203, EU Method C.1 and ISO 7346 -1. Carp (Cyprinus carpio) were exposed to water accomodated fractions (WAFs) prepared at concentrations of 0 (control), 1.0, 10, 100 mg/L under static conditions. The total exposure period was 96 h and samples for analytical confirmation of actual exposure concentrations were taken at the start and at the end of the test at the concentration of 100 mg/L. Mortality and other effects were recorded at 2, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from Day 0 and every morning from Day 1, observations for any dead or severely distressed fish were realized.

No mortality was observed in any of the dose groups. The actual concentration in the sample taken from the WAF prepared at 100 mg/L was 0.155 mg/L at test start, dropping to 0.079 mg/L by test end (51% of initial–note that this value was extrapolated and is therefore only indicative). Based on these results, the average exposure concentration was calculated to be 0.11 mg/L (i.e., equivalent to 100mg/L nominal concentration). Under the study conditions, the 96 h LC50 and NOEC for carp were determined to be > 0.11 and 0.11 mg/L, respectively (Tobor-Kaplon, 2012). This corresponds to a nominal concentration of 100 mg/L.