2-Propenoic acid, reaction products with pentaerythritol

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 March to July 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines in compliance with GLP.

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

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 2: Semi-static method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 1.0, 2.2, 4.6, 10 and 22 mg/L (loading rate)
- Sampling method:
Frequency: 0, 24 and 96 h
Volume: 3 ml
- Sample storage conditions before analysis: Samples were stored in a freezer

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

RANGE-FINDER
Test solution was prepared by diluting 100 mg/L test substance in water and applying magnetic stirring for 21 hours. This resulted in a clear solution with a floating layer. The floating layer was left to settle for 30 minutes and the water phase was collected. Lower concentrations were prepared by serial dilution of the water phase in test medium.

FINAL STUDY
Test solutions were individually prepared with loading rates between 10 and 100 mg/L. A magnetic stirring period of 22 hours was followed by a settlement period of 35 minutes. The water accomodated phase was then siphoned off and used for testing. The final test solutions were all clear and colourless.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: carp
- Source: Zodiac, proefacc., "de Haar Vissen", Wageningen University and Research Center, The Netherlands
- Length at study initiation (length definition, mean, range and SD): RANGE-FINDER: 2.2 +/- 0.2 cm; MAIN STUDY: 2.4 +/- 0.3 g
- Weight at study initiation (mean and range, SD): RANGE-FINDER: 0.16 +/- 0.04 g; MAIN STUDY: 0.23 +/- 0.02 g
- Feeding during test: no feeding from 24 h prior to test start and throughout the study

ACCLIMATION
- Acclimation period: at least 12 days
- Type and amount of food: pelleted food, Cyprico Crumble Excellent (300 - 500 um), Coppens INternational, Helmond, The Netherlands
- Feeding frequency: daily

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

CaCO3: 180 mg/L

Test temperature:

20.9 - 21.8 °C

pH:

7.2 - 8.1

Dissolved oxygen:

5.9 - 9.2

Aeration introduced after 72 h of exposure as dissolved oxygen concentrations tended to drop below 5 mg/L.

Nominal and measured concentrations:

TEST START
- Nominal: 0, 1.0, 2.2, 4.6, 10 and 22 mg/L
- Measured: n.d., 0.976, 2.15, 4.51, 9.10 and 20.5 mg/L

5 HOURS
- Nominal: 22 mg/L
- Measured: 19.7 mg/L

24 HOURS
- Nominal: 0, 1.0, 2.2, 4.6 and 10 mg/L
- Measured: n.d, 0.958, 2.13, 4.49 and 9.26 mg/L

48 HOURS
- Nominal: 4.6 mg/L
- Measured: 4.45 mg/L

96 HOURS
- Nominal: 0, 1.0 and 2.2 mg/L
- Measured: n.d, 0.88 and 1.95 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 35 L glass tank containing 3 L of test medium
- Aeration: Introduced in the main test after 72 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- Biomass loading rate: 0.54 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium with a hardness of CACO3 = 180 mg/L and a pH of 7.7 +/- 0.3

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality and effects after 3 1/4, 24, 48, 72 and 96 h. Additionally every afternoon as of Day 0 and every morning as of Day 1 to observe for any dead or distressed fish.
- Dissolved oxygen, pH, temperature: daily

TEST CONCENTRATIONS
- Range finding study: WAFs at loading rates of 0, 10, 18, 32, 56 and 100 mg/L
- Test concentrations: WAFs at loading ratesof 0, 1.0, 2.2, 4.6, 10 &nd 22 mg/L

Reference substance (positive control):

yes

Remarks:

Pentachlorophenol

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

2.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Remarks:

as a Water Accomodated Fraction

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Remarks:

as a Water Accomodated Fraction

Basis for effect:

mortality (fish)

Remarks on result:

other: 2.2 - 4.6

Details on results:

- Besides the total mortality observed in the WAFs prepared at 4.6, 10 and 22 mg/l, no clinical effects were observed at any of the test concentrations.
- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? yes

The 96 h LC50 for carp exposed to PCP was estimated to be 0.15 mg/L (95 % confidence interval between 0.10 and 0.22 mg/L). This effect was already reached within 24 h of exposure.

The range of the 96 h 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.

Reported statistics and error estimates:

The 24 h LC50 was determined using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations (Finney DJ, 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition)
The 48-96 h LC50 could not be determined using Finney, Probit analysis. This was because there was no concentration between the highest concentration (A) at which 0% mortality and the lowest concentration (B) at which 100% mortality occurred. Instead, the LC50 was calculated as (AB)½, with A and B being limits of the 95% confidence interval.

Sublethal observations / clinical signs:

None

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study, the 96 h LC50 of the substance to carp (Cyprinus carpio) was 3.2 (2.2 - 4.6) mg/L. The 96 h NOEC was 2.2 mg/L, with 100% mortality at the next highest dose.

Executive summary:

A study was conducted to determine the acute toxicity of PETIA to common carp (Cyprinus carpio) under static conditions according to OECD Guideline 203.

Fish were exposed to the substance as a Water Accomodated Fraction (WAF) at loading rates ranging from 10 to 100 mg/L in a first test and 1.0 to 22 mg/L in a second test. Test medium samples were taken at 0, 5, 24, 48 and 96 h for analysis of test substance concentrations.

100% mortality was observed at 4.6 mg/L and above within 1 to 2 days. There were no clinical signs at any dose. Measured concentrations were within 20% of nominal values. Results were based on nominal values (as WAF).

Under the conditions of this study, the 96 h LC50 of the test substance to carp (Cyprinus carpio) was 3.2 (2.2 - 4.6) mg/L. The 96 h NOEC was 2.2 mg/L, with 100% mortality at the next highest dose.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

3.2 mg/L

Additional information

A study was conducted to determine the acute toxicity of PETIA to common carp (Cyprinus carpio) under static conditions according to OECD Guideline 203. Fish were exposed to the substance as a Water Accomodated Fraction (WAF) at loading rates ranging from 10 to 100 mg/L in a first test and 1.0 to 22 mg/L in a second test. Test medium samples were taken at 0, 5, 24, 48 and 96 h for analysis of test substance concentrations. 100% mortality was observed at 4.6 mg/L and above within 1 to 2 days. There were no clinical signs at any dose. Measured concentrations were within 20% of nominal values. Results were based on nominal values (as WAF). Under the conditions of this study, the 96 h LC50 of the test substance was 3.2 (2.2 - 4.6) mg/L. The 96 h NOEC was 2.2 mg/L, with 100% mortality at the next highest dose (Migchielsen, 2010).