2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide

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 April 29, 2004 to May 28, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: ISO International Standard 7346-2: “Water quality – Determination of the acute lethal toxicity of substances to a freshwater fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)]” – Part 2: Semi-static method, Second edition, 1996-06-15.

Deviations:

yes

Remarks:

but the study was not adversely affected by this deviation

GLP compliance:

yes

Specific details on test material used for the study:

Identification: PARAD Substance 139
Batch: 31104251
Physical state: slightly yellowish viscous liquid
Purity: n.a. (mixture)

Analytical monitoring:

yes

Details on sampling:

The analytical results showed that measured test substance concentrations in samples taken from nominally 100 mg/L decreased from 96 mg/L at the start to 79 mg/L after 24 hours and to 32 mg/L after 96 hours of exposure. Consequently, it was decided to continue with renewal of test solutions after each 24h period to maintain concentrations at > 80% relative to initial.
Sampling: frequency at t=0 h, t=24 h and t=96 h. Volume 10 ml from the approximate centre of the test vessels. Storage Samples were stored in a freezer until analysis.
Preparation of test solutions started with a stock solution of 100 mg/L applying 15 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 stock in test medium. Test solutions were renewed after each 24-hour interval during the limit test. The final test solutions were all clear and colourless.

Vehicle:

yes

Details on test solutions:

A combined limit/range-finding test was performed. The project started with a static range-finding test exposing three carp per concentration to nominal test concentrations concentrations of 0.1, 1.0, 10 and 100 mg/L. No effects were observed during the test period up to and including 100 mg/L. The project was continued with a limit test exposing seven carp per concentration to a blank control and a nominal test substance concentration of 100 mg/L applying a semi-static test design. Samples for analyses were taken from the freshly prepared solutions at the start and after 72 hours and from 24-hour spent solutions after 24 and 96 hours of exposure.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Species: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands.
Mean length: 2.3 ± 0.2 cm.
Mean weight: 0.30 ± 0.10 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

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

250 mg CaCO3 per litre

Test temperature:

20.9- 22.1°C

pH:

6.1 - 6.5

Dissolved oxygen:

Oxygen > 60% of air saturation value

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

0.1, 1.0, 10 and 100 mg/L (nominal concentrations)

Details on test conditions:

Test vessels: 6.5 litres, all-glass, containing 5 litres of test medium.
Test medium: ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilised
Number of fish: 7 fish per concentration and control
Loading: 0.39 g fish/litre, i.e. 7 fish per 5 litres of test medium
Illumination: 16 hours photoperiod daily
Aeration: the test media were not aerated during the test
Feeding: no feeding from 48 hours prior to the test and during the total test period
Introduction of fish: within ¾ hour after preparation of the test media
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 (PCP, concentrations: 0.10, 0.22 and 0.46 mg/L in ISO-medium)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 could not be calculated because the test substance proved to be non-toxic

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No mortality or clinical effects were observed in the limit test.

Details on results:

No LC50 could be calculated because the test substance proved to be non-toxic (LC50 > maximum concentration tested). No mortality or clinical effects were observed during the limit test.

Results with reference substance (positive control):

PCP induced no lethal effects in carp at or below 0.22 mg/L. The 96h-LC50 for carp exposed to PCP was 0.32 mg/L (95 % confidence interval between 0.22 and 0.46 mg/l) and already reached within 24 hours of exposure. The range of the 96hLC50 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. The response observed in carp originating from the present batch falls within this range.

Sublethal observations / clinical signs:

- Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24-hour spent solutions. Recoveries ranged between 87 and 97% of nominal. Hence, further results were based on nominal concentrations.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96h LC50 and NOEC for carp (Cyprinus carpio) were determined to be: > 100 mg/L and 100 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 -2. Carp were exposed to the test substance at concentrations of 0.1, 1.0, 10 and 100 mg/L (nominal) for 96 h under static conditions. Samples for analytical confirmation were taken from the freshly prepared solutions at the start and after 72 h and from 24-h spent solutions after 24 and 96 h of exposure. Mortality and other effects were observed at 2¾, 24, 48, 72 and 96 h following the start of exposure. Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24-h spent solutions. Recoveries ranged between 87 and 97% of nominal. Hence, further results were based on nominal concentrations. The test substance induced no visible effects in carp at or below 100 mg/L (NOEC). Hence, no LC50 could be calculated (i.e., LC50 > maximum concentration tested). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the study conditions, the 96 h EC50 for carp (Cyprinus carpio) was considered to be >100 mg/L and the 96 h NOEC at 100 mg/L (Migchielsen, 2004).

Description of key information

The LC50 of the substance was determined to be >100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

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 -2. Carp were exposed to the test substance at concentrations of 0.1, 1.0, 10 and 100 mg/L (nominal) for 96 h under semi-static conditions. Samples for analytical confirmation were taken from the freshly prepared solutions at the start and after 72 h and from 24-h spent solutions after 24 and 96 h of exposure. Mortality and other effects were observed at 2 h 45 minutes, 24, 48, 72 and 96 h following the start of exposure. Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24-h spent solutions. Recoveries ranged between 87 and 97% of nominal. Hence, further results were based on nominal concentrations. The test substance induced no visible effects in carp at or below 100 mg/L (NOEC). Hence, no LC50 could be calculated (i.e., LC50 > maximum concentration tested). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the study conditions, the 96 h EC50 for carp (Cyprinus carpio) was considered to be >100 mg/L and the 96 h NOEC at ≥100 mg/L (Migchielsen, 2004).