Phosphoric acid, mono- and di-C12-18-(even numbered)-alkyl esters, sodium salts

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 December 16, 2016 to March 15, 2017

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:

but the study integrity was not adversely affected by these deviations

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

but the study integrity was not adversely affected by these deviations

GLP compliance:

yes

Specific details on test material used for the study:

Batch no.: SEALS: 2011-104-06-01
Purity/composition: 96.75%
Appearance: white solid

Analytical monitoring:

yes

Remarks:

TOC content measurement

Details on sampling:

- Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to reach the maximum dissolution of the test substance in medium. Thereafter, the aqueous Saturated Solution (SS) was collected by means of filtration through a 0.45 μm membrane filter (RC55, Whatman) and used as the highest test concentration. Lower concentrations for the range-finding test were prepared by subsequent dilutions of the SS in test medium. All test solutions were clear and colorless at the end of the preparation procedure.
- Samples for possible analysis were taken from the limit concentration and the control according to the schedule below. In addition, the filter used to prepare the SS was retained in a freezer (≤ -15°C) for possible analysis of the residue.
Frequency: at t=0 h, t=24 h and t=96 h
Volume: 40 mL
Storage: Samples were stored in a refrigerator (2-8°C) until analysis.
Additionally, reserve samples of 40 mL were taken from all test solutions for possible analysis. If not already used, these samples were stored in a refrigerator (2-8°C) for a maximum of three months after delivery of the draft report.

Vehicle:

no

Details on test solutions:

Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to reach the maximum dissolution of the test substance in medium.

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, Final test: 3.4 ± 0.2 cm
Mean weight: Range-finding test: 0.28 ± 0.10 g, Final test: 0.59 ± 0.16 g
Characteristics: F1 from a single parent-pair bred in UV-treated water
Total fish used: 23
Quarantine/Acclimatisation: At least 12 days after delivery
Feeding: Daily with pelleted fish food (Essence (300-500 um), Coppens International bv, Helmond, The Netherlands)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

180 mg CaCO3 per litre

Test temperature:

21-22°C

pH:

7.7 ± 0.3

Dissolved oxygen:

5.9 to 9.2 mg/L

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

Preliminary dose-range finding test: 0, 1.0, 10 and 100 mg/L
Limit test: 100% of a SS prepared at 100 mg/L (Control: Test medium without test substance or other additives)

Details on test conditions:

Test procedure and conditions:
- Test duration: 96 hours
- Test type: Static
- Test vessels: 10 litres, all-glass, containing 9 litres of test solution
- Test medium: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3.
- Number of fish: 7 per concentration
- Loading 0.46 g fish/Litre, i.e. 7 fish per 9 litres of test medium
- Illumination: 16 hours photoperiod daily
- Aeration: Aeration was introduced after after 48 hours of exposure and was maintained for 7 hours
- Feeding: No feeding from 24 hours prior to the test and during the total test period
- Introduction of fish: Within 30 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 1.0°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 (PCP)

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: the 96h-LL50 was above 100% of a saturated solution prepared at a loading rate of 100 mg/L

Details on results:

No mortality or clinical effects were observed at the limit concentration and the control during the test period. The responses recorded in this test allowed for reliable determination of an LL50. The responses recorded in 100% of the SS were in agreement with the results of the range-finding test.

Results with reference substance (positive control):

Under the conditions of the present test, all carp exposed to a PCP concentration of 0.46 mg/L died within 24 hours, while no mortality occurred at 0.10 and 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). This effect was already reached within 24 hours of exposure.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96h-LL50 of the test substance in carp was above 100% of a saturated solution prepared at a loading rate of 100 mg/L.

Executive summary:

A study was conducted to determine the acute toxicity of the test substance, mono- and di- C12-18 PSE, Na+, to fish according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Seven fish (Cyprinus carpio) per group were exposed to a control and to 100% of the saturated solution (SS) of the test substance. The total exposure period was 96 h and the experiment was realised under static conditions. Due to the complex nature of the test substance, specific analyses proved to be difficult to obtain and it was decided to analyse the Total Organic Carbon (TOC) concentration as a surrogate measure. Samples for TOC concentrations were taken at the start and after 24 and 96 h of exposure. The TOC analysis performed on samples taken from 100% of the SS were regarded as indicative because of the low carbon concentrations. Effect parameters were based on the percentages of the saturated solution prepared at a loading rate of 100 mg/L. No mortality or clinical effects were observed at the limit concentration and the control during the test period. The responses recorded in this test allowed for reliable determination of an LL50. The study met the acceptability criteria prescribed by the study plan and was considered valid. Under the study conditions, the 96 h-LL50 of the test substance was above 100% of a saturated solution prepared at a loading rate of 100 mg/L (Bouwman, 2017).

Description of key information

The 96 h-LL50 for the test substance to Cyprinus carpio was determined to be above 100% of a saturated solution prepared at a loading rate of 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 acute toxicity of the test substance, mono- and di- C12-18 PSE, Na+, to fish according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Seven fish (Cyprinus carpio) per group were exposed to a control and to 100% of the saturated solution (SS) of the test substance. The total exposure period was 96 h and the experiment was realised under static conditions. Due to the complex nature of the test substance, specific analyses proved to be difficult to obtain and it was decided to analyse the Total Organic Carbon (TOC) concentration as a surrogate measure. Samples for TOC concentrations were taken at the start and after 24 and 96 h of exposure. The TOC analysis performed on samples taken from 100% of the SS were regarded as indicative because of the low carbon concentrations. Effect parameters were based on the percentages of the saturated solution prepared at a loading rate of 100 mg/L. No mortality or clinical effects were observed at the limit concentration and the control during the test period. The responses recorded in this test allowed for reliable determination of an LL50. The study met the acceptability criteria prescribed by the study plan and was considered valid. Under the study conditions, the 96 h-LL50 of the test substance was above 100% of a saturated solution prepared at a loading rate of 100 mg/L (Bouwman, 2017).