Tall oil, maleated

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study initial date: Nov. 10, 2014 Study completion date: Jul. 17, 2015

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:

no

Qualifier:

according to guideline

Guideline:

other: The guidelines for the testing of chemicals (HJ/T 153-2004)

Qualifier:

according to guideline

Guideline:

other: The guidelines for the testing of chemicals, Effects on Biotic Systems (the 2nd edition) (2013)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Samples were taken (in duplicate) from each concentration during the definitive test at 0, 24, 48, 72 and 96 h. On each occasion, one sample was analysed after pre-treatments; the remaining samples were retained in case further analysis would be required.

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

The test species of Rare minnow, Gobiocypris rarus (Batch No.: F20150415G), was used in the test on the basis of such important practical criteria as, for example, their ready availability throughout the year, ease of maintennance, convenience for testing and any relevant economic, biological or ecological factors. The fish were obtained from a commercial fish supplier of Institute of Hydrobiology, Chinese Academy of Science.
Fish to be used in the test were held for 7 days in water of the quality and temperature to be used in the test.
After the 48 hour settling-in period, no mortality was observed in the following 7 days. So the batch of fish was accepted.
The average wet-weight and lenght of the fish used to the test was 0.214 g and 2.48 cm and the relative standard deviation (RSD) was 8.13% and 5.95% respectively.

Test type:

static

Water media type:

other: Tap water dechlorinated for at least 24 hours

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not relevant

Hardness:

145.0 mg (CaCO3)/L

Test temperature:

23.2 - 23.4 Celsius degrees

pH:

7.82

Dissolved oxygen:

71% to 97% of the air saturation; no aeration

Nominal and measured concentrations:

The mean of the measured concentrations were 0.299, 0.780, 1.92, 2.98, 3,94 and 5,73 mg/L.
The nominal concentrations were 10%, 20%, 40%, 60%, 80% and 100%.

Details on test conditions:

A blank control was used in the test. No replicate was assigned for each treatment group and control group, while the initial number of testing fish was 10 for each group. The test fish were randomly chosen and put in appropriate test solutions after the temperature had been adjusted to the required value. This was done within 30 minutes.
During the test the following conditions were mantained:
- light: 16 hours photoperiod daily
- temperature: 23.2 to 23.4 celsius degrees
- oxygen concentration:71% to 97% of the air saturation; no aeration.
- feeding: none

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.16 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

0.299 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

2.98 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

2.1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

1.83 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

1.56 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

During the test period all fish in the control and treatment of 10% saturated solution were alive and appeared normal. Effects (Fish lying on side or back) occurred at nominal test concentrations of 20% saturation solution and above. All fish were dead after 96h exposure at nominal test concentration of 60% saturated solution and above.

Results with reference substance (positive control):

With the conditions mantained as designed for the definitive test, potassium dichromate was used as the test substance and the resulting 24h LC50 was 278 mg/L.

Reported statistics and error estimates:

Trimmed Spearman - Karber method (Version 1.5, USEPA) can be used to calculate the LC50 and 95% confidence limits.

Validity criteria fulfilled:

yes

Conclusions:

The results showed that under valid static test conditions, the 96h LC50 of the test substance to fish (Rare minnow, Gobiocypris rarus) is 1,16 mg/L, with 95% confidence limit of 0.87 mg/L ˜ 1.55 mg/L (based on the measured concentrations).

Executive summary:

Under static condition, the acute toxicity of test substance (Tall oil maleated) to Rare minnow (Gobiocypris rarus) was conducted according to: “The guidelines for the testing of chemicals” (HJ/T 153-2004), “The guidelines for the testing of chemicals, Effects on Biotic Systems” (the 2nd edition) (2013); and with reference to Procedure 203 of the “Guidelines for testing of Chemicals” of the OECD: “Fish, Acute toxicity Test” (1992).

A range finding test and then a definitive test were performed respectively. Nominal concentrations of 10%, 20%, 40%, 60%, 80% and 100% saturated solutions were used in the definitive test. Water samples taken from the blank control and the treatments in the definitive test were analysed. Concentrations of the test substance were quantified using GC-MS. The mean of the measured concentrations were 0.299, 0.780, 1.92, 2.98, 3,94 and 5,73 mg/L respectively.

The analytical results showed that the concentration of the test substance is consistent in the test medium troughout the 96 hour test period (deviation within 20%). Thus a static procedure was reasonable.

In the range finding test, 5 fish per treatment and no replicates were used. And 10 fish per treatment of no replicates were used in the definitive test. The test fish were exposed for 96 hours to the test solution.

During the test period, the pH values of the control mediums and test mediums were between 7.79 and 7.96, the Dissolved Oxygen (DO) values varied from 71% - 97% of the air saturation at the test temperature, the temperature of the test mediums were maintained in the range of 23.2 °C - 23.4 °C, and all fish in the control group were normal. The total hardness was in the range of 142 mg (CaCO3)/L to 152 mg (CaCO3)/L in the beginnning of the definitive test. With the same conditions, K2Cr2O7 was used as the positive control substance and the resulting 24 h LC50 was 278 mg/L. So the study met the acceptability criteria prescribed by the protocol (The mortality of control ≤10%; pH:6.0 ˜8.5; dissolved oxygen concentration: >60% of the air saturation value ; total hardness: 10 ˜250 mg (CaCO3)/L; temperature: (23 ±2) °C; 24 h LC50 of K2Cr2O7 in the range of 200 mg/L to 400 mg/L). Therefore, the test was considered valid.

During the test period, all fish in the control and treatment of 10% saturated solution were alive and appeared normal. Effects (Fish lying on side or back) occurred at nominal test concentrations of 20% saturated solution and above. All Fish were dead after 96h exposure at nominal test concentration of 60% saturated solution and above. The results showed that under valid static test conditions, the 96h LC50 of the test substance to fish (Rare minnow, Gobiocypris rarus) is 1,16 mg/L, with 95% confidence limit of 0.87 mg/L - 1.55 mg/L (based on the measured concentrations). The maximum tested concentration causing no mortality (96 hLC0) is 0.299 mg/L. The minimum concentration causing 100% mortality (96 h LC100) is 2.98 mg/L i.e.:

96 h LC50: 1.16 mg/L (based on the measured concentration);

96 h LC0: 0.299 mg/L;

96 h LC100: 2.98 mg/L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 29 July to 02 August 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: OSPAR / PARCOM Protocols on methods for the testing of chemicals used in the Offshore industry 2006

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot number 8972-06A (Cof A)

Analytical monitoring:

no

Test organisms (species):

other: Scophthalamus maximus

Details on test organisms:

Source of fish: France Turbot Boite Postale 305- 58330 Noirmoutiers- France.
Feeding regime: the turbot were fed daily using Le Gouessant Turbot Label Rouge at a rate of approximately 1% body weught per day until 24 hours befor test initiation. The Turbot were not fed for the duration of the study.
Mean lenght: 53 mm (range: 45 to 60 mm)
Mean weight: 1.94 g (range: 1.14 to 2.82 g)
Loading rate of fish in study: 0.68 g/L

Test type:

semi-static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

15.5 °C

pH:

8.29

Dissolved oxygen:

95% ASV

Salinity:

31%

Details on test conditions:

Information from the Sponsor led to the decision to treat the test item as insoluble in seawater.
The exposure concentration was prepared by adding 0.7501 g on day -2 and 0.7502 g on day 0 to 22 litres of dilution water, then stirred for 46 hours and 10 minutes on day -2. On day 0, the exposure concentration was stirred for 45 hours and then allowed to separate for three hours on day -2 and 3 hours and 15 minutes on day 0. The sub-natant liquid was drawn off and used for the test on days -2 and 0 respectively. A clear colourless liquid with floating material was observed.
The lowest EC50 value found in earlier studies using the algal species Skeletonema costatum (CEFAS range finding result: between 10 and 100 mg/L) and the invertebrate Acartia tonsa (CEFAS study plan number P0021L) was 34.11mg/L. Therefore, the limit test with turbot was conducted at the single concentration of 34.1 mg/L. Test dilutions of EnvaMul 600 as received were prepared on day -2 and day 0 of the test. The fish were transferred to fresh test dilutions on day 2.
Test period: 29 July to 02 August 2013

Test volume: 20 litres

Test vessel: 20 litre glass aquaria (length 46 cm, width 25 cm, height 26 cm)

Number of replicates: 1 replicate at each control and test concentration.

Test organism: Seven Turbot were placed in both of the control and test vessel.

Replacement regime: Semi-static, all the remaining live animals were transferred to freshly prepared test solutions at 48 hours.

Test conditions: The test vessels were maintained at 15.5 °C with a photo period of 16 hours light and 8 hours dark.

Water quality measurements: The pH (to 0.01), dissolved oxygen (to 1% ASV), temperature (to 0.5 °C) and salinity (to 1‰) were measured. Water quality determinations for each test and control solution were carried out immediately prior to initiating the test, after 24 hours, before and after the 48 hour change of test solutions, after 72 hours and at the end of the 96-hour exposure period.

Observation frequency: Observations and records of mortalities were made after 3, 24, 48, 72 and 96-hour exposure periods.

Calculation of results: The results are reported as nominal concentrations of the test substance as received. Where no mortalities occur in the limit test there is a 99% level of confidence that the LC50 is greater than the concentration tested (2).

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 34.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

The 96-hour LC50 value of EnvaMul 600 to Turbot was determined to be >34.1mg/L. Where no mortalities occur in the limit test there is a 99% level of confidence that the LC50 is greater thanthe concentration tested.
The highest no observed effect concentration (NOEC) after 96-hours was 34.1 mg/L.
A mortality of 0% was observed in the control tank at the end of the test period. This is within the range of mortality acceptable for validation of the test results.
No abnormal behaviour or other visible sub-lethal effects were observed during the test.
There were no incidents recorded during the course of the test that may have influenced the results of the test.
The full water quality measurements were within acceptable limits. Specifically, the dissolved oxygen concentration remained greater than 60% of the air saturation value, which fulfils the validity criteria of the study.
The test substance nominal concentration was prepared as a "water-accommodated fraction" according to the OSPAR (2005) guidelines. There was no chemical analytical confirmation of the actual dissolved concentration. The dissolved concentration was likely to be lower than the nominal concentration given in the report as EnvaMul 600 was poorly soluble in water.

Validity criteria fulfilled:

yes

Conclusions:

The aquatic toxicity of Envamul 600 to Turbot was tested over a 96 h period in salted water.
The limit test was conducted using the LC50 or EC50 of the most sensitive species of the other taxonomic groups that have been tested. Since no significant mortality occurred in this limit test (when compared with the control), it was unnecessary to undertake a full toxicity test and the end point has been reported as greater than the concentration tested.
The LC50 (96h) of Envamul 600 resulted to be grater than 34.1 mg/L.

Executive summary:

The aquatic toxicity of Envamul 600 to Turbot  was tested over a 96 h period in salted water.

The limit test was conducted using the LC50 or EC50 of the most sensitive species of the other taxonomic groups that have been tested. Since no significant mortality occurred in this limit test (when compared with the control), it was unnecessary to undertake a full toxicity test and the end point has been reported as greater than the concentration tested.

The LC50 (96h) of Envamul 600 resulted to be grater than 34.1 mg/L.

Description of key information

The acute toxicity of test substance (Tall oil, maleated) to Rare minnow (Gobiocypris rarus) was tested under static condition. A range finding test and then a definitive test were performed respectively.

The results showed that under valid static test conditions, the 96h LC50 of the test substance to fish (Rare minnow, Gobiocypris rarus) is 1,16 mg/L, with 95% confidence limit of 0.87 mg/L - 1.55 mg/L (based on the measured concentrations).

The aquatic toxicity of Envamul 600 to Turbot (Scophthalamus maximus) was tested over a 96 h period in salted water.

The limit test was conducted using the LC50 or EC50 of the most sensitive species of the other taxonomic groups that have been tested. Since no significant mortality occurred in this limit test (when compared with the control), it was unnecessary to undertake a full toxicity test and the end point has been reported as greater than the concentration tested.

The LC50 (96h) of Envamul 600 resulted to be greater than 34.1 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1.16 mg/L

Marine water fish

Marine water fish

Effect concentration:

34.1 mg/L