Tall oil, maleated

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study initiation date: 2014-01-30; Experimental completion date:2014-03-09;

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot number QD16

Analytical monitoring:

yes

Details on sampling:

Samples of the range finding test and the definitive test (exposure and control) solutions were collected in 100 mL (min) capacity glass sample bottles pre-cleaned with teflon lined caps (no preservative). The vials were filled, living very little headspace. Samples were collected immediately prior to test commencement (0 hour) and at test termination (48 hour, from pooled replicates) for measurement of the test item. The 0 hour samples were stored at 4 ±2 °C in the dark until test termination.
For the range finding test a single set of samples were collected for analysis to corfirm the exposure concentrations brecketing the LC50 concentration plus the control.
For the definitive test, duplicate samples were collected from all exposure concentrations plus the control. One set of each 0 hour and 48 hour were analysed, the other set was retained by the laboratory to be used in the event that a sample is lost, damaged or if re-analysis is required.

Details on test solutions:

Individual test solutions were prepared on a volume:volume basis by adding an appropriate amount of the certified stock solutions to the laboratory dilution water.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna STRAUS were cultured continuously from a population that has been actively reproducing in the laboratory since 1988. The organisms were originally obtained from the Ministry of the environment (Toronto, Ontario, Canada).
Culturing and holding of the species prior to testing was conducted according to the laboratory SOP #230.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

ca 200 mg/L as CaCO3;

Test temperature:

20 ±2 °C

pH:

8.0 - 8.5

Nominal and measured concentrations:

Range-finding test: 4 concentrations of the test item (including 0.1, 1.0, 10 and 100 mg/L) plus a stock preparation control and a standard laboratory control (100% dilution water)
Definitive test: 5 concentrations of the test item (including 22.6, 45.1, 90.3, 180.5 and 361 mg/L) plus a stock preparation control and a standard laboratory control (100% dilution water)

Details on test conditions:

Light quality: ambient laboratory illumination
Light intensity: 400 to 800 lux
Photoperiod: 16 hour light, 8 hour dark (with 30 minute transition period)
Feeding prior to test: once/day
Feeding regime: none during test
Test chamber: glass beaker (250 mL)
Loading rate: 15 mL/ daphnid
Test volume 100 mL
Age of test organism: first instar, neonate (less than 24 hours old)
Number of replicates: 2 for range-finding test; 4 for definitive test
Number of anumals per test chamber: 5
Aeration: none

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

218 mg/L

Nominal / measured:

estimated

Conc. based on:

act. ingr.

Basis for effect:

mobility

Reported statistics and error estimates:

Statistical analysis of the actute toxicity test data was conducted in accordance with AquaTox SOP #11 (AquaTox 2013b). The CETIS (2007) program was used to calculate the 24- and 48-hour EC50s (and 95% Confidence Limits) by the binomial method.

Validity criteria fulfilled:

yes

Conclusions:

Since not all measured concentrations were within their respective nominal concentrations, the 24 and 48 hour LC50 were calculated using the Time weighted Mean (mg/L). As such the 24 and 48h EC50 were the same, estimated to be 218 mg/L.

Executive summary:

AcquaTox Testing & Consulting Inc. (AquaTox) was retained by the Sponsor’r Representative, Intertek Cantox (Intertek) to conduct a study to determine the acute toxicity of the test item tall oil, maleated to Daphnia magna under static test conditions. The study was conducted according to AquaTox study plan 162775293-200 entitled “Tall oil, Maleated: Evaluation of Acute Ecotoxicity to Daphnia magna” (OECD 202)” (Appendix A) and Aquatox SOP #341, which are based on OECD Guideline 202 (OECD 2004). This study was conducted in accordance with the OECD Series on Principles of Good Laboratory Practice (GLP) Number 1 (OECD 1998) and Number 13 (OECD 2002).

The ecotoxicity testing component of this study was conducted by AquaTox. Chemical analysis in support to this study, was conducted by Investigative Science Incorporated (ISI) and included: method development and validation, preparation of certified stock solutions for use in conducting the range-finding test and definitive tests and analysis of all control and test solutions for confirmation of exposure. All components of the study were conducted according to OECD GLP (OECD 1998, 2002), with the exceptions noted in the GLP Compliance Statement.

Range-finding and definitive tests were conducted using the certified stock solutions prepared by ISI. The concentration of the stock solution prepared by ISI was 441.6 mg/L and the highest nominal concentration tested was 100 mg/L. Immobilization of daphnids was not observed in any of the test or control exposures. Based on these results, the 48 hour EC50 for Tall oil, maleated was expected to be greater than 100 mg/L (i.e. the highest concentration tested).

The concentration of the stock solution for the definitive test was prepared by ISI and was 361 mg/L. Since not all nominal and measured concentrations of test item were within 20%, calculation of the 24 and 48 hour EC50s were based on measured concentrations specifically time-weighted mean concentrations (OECD 2012). Complete 100% immobility of daphnids was observed at the highest concentration of 361 mg/L within the first 24 hour of exposure, but no immobility (0%) was observed at any of the lower concentrations including the controls. No additional immobility was observed during the remainder of the test thus the 24 and 48 hour EC50s were the same estimated to be 218 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: ISO 14669 (1999): Water Quality - Determination of acute lethal toxicity to marine copepods

Deviations:

yes

Remarks:

Four deviations from the study plan occurred. The deviations were determined not to have affected the validity of the study.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

A solubility study was conducted on EnvaMul 600. This was achieved by adding 1 g of the test item to 1L of natural seawater (filtered to 0.2 µm and collected from Lowestoft bay). Based on the results of the solubility test EnvaMul 600 was both difficult to tranfer and not soluble in seawater. Therefore, the test solutions were prepared as water accomodated fractions (WAF).

Test organisms (species):

other aquatic arthropod: Acartia tonsa

Details on test organisms:

The test organism were obtained from Guernsey Sea Farms and were acclimatated to test temperature before use. The test organism was approximately 11 - 13 days on arrival.

Test type:

static

Water media type:

other: seawater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

19.2 - 20.0 °C

pH:

7.8 - 8.5
The pH at the end of the study was above the limis in all beakers. The highest pH observed was 8.5. As the control mortality was acceptable and the pH increase was small and therefore was not deemed to affect the test validity.

Dissolved oxygen:

6.96 mg/L

Salinity:

29.5 - 34.9 ppt
At the end of the study the salinity was out of limits for the reference test. The maximum salinity was 37 ppt. As the control mortality was acceptable and the increase was small it is therefore not deemed to have affected the test validity.

Nominal and measured concentrations:

Nominal concentrations were chosen as 0.1, 3.2, 10, 32, 100, 320 mg/L Envamul 600.

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

34.11 mg/L

Conc. based on:

act. ingr. (dissolved fraction)

Basis for effect:

mortality

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

84.64 mg/L

Conc. based on:

act. ingr. (dissolved fraction)

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

32 mg/L

Results with reference substance (positive control):

48 h EC50 for reference substance (3,5-Dichlorophenol) was 0.6 mg/L (calculated with Spearman Karber method). The value is within the acceptable limits (0.5 to 1.5 mg/L) for the definitive test according to the test guideline ISO 14669 (1999).

Validity criteria fulfilled:

yes

Conclusions:

The median lethal concentration (EC50) of Envamul 600 to Acartia Tonsa after 48h exposure was 34.11 mg/L with 95% confidence limits between 26.41 and 44.04 mg/L. All the validity criteria have been met and therefore this test can be accepted as valid.

Executive summary:

A 48 hour toxicity assay was conducted with EnvaMul 600 using the marine copecod Acartia Tonsa according to the guideline ISO 14669 (1999) "Water quality determination of acute lethal toxicity to marine copepods ".

A solubility study was conducted on EnvaMul 600. This was achieved by adding 1 g of the test item to 1L of natural seawater (filtered to 0.2 µm and collected from Lowestoft bay). Based on the results of the solubility test EnvaMul 600 was both difficult to tranfer and not soluble in seawater. Therefore, the test solutions were prepared as water accomodated fractions (WAF).

A range finding and a definitive test has been conducted.

The definitive study was conducted with 4 replicates per concentrations, with 8 replicates for controls. The test concentrations were chosen as 0.1, 3.2, 10, 32, 100, 320 mg/L of Envamul 600.

The median lethal concentration (EC50) of Envamul 600 to Acartia Tonsa after 48h exposure was 34.11 mg/L with 95% confidence limits between 26.41 and 44.04 mg/L. All the validity criteria have been met and therefore this test can be accepted as valid.

Description of key information

A study to determine the acute toxicity to Daphnia magna of the test item has been conducted under static conditions. Since not all measured concentrations were within their respective nominal concentrations, the 24 and 48 hour LC50 were calculated using the TWM values. As such, the 24 and 48 h EC50s were the same, estimated to be 218 mg/L.

The median lethal concentration (EC50) of Envamul 600 to Acartia Tonsa after 48h exposure was 34.11 mg/L with 95% confidence limits between 26.41 and 44,04 mg/L. All the validity criteria have been met and therefore this test can be accepted as valid.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

218 mg/L

Marine water invertebrates

Marine water invertebrates

Effect concentration:

34.11 mg/L