Tall oil, potassium salt

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:

24 April 2006 to 26 May 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. Study read-across from supporting substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: A Water Accommodated Fraction (WAF) was prepared at a loading rate of 100 mg/L.
- Sampling method: Samples for TOC analysis and quantitative GCMS analysis of the control and test loading rate 100 mg/L were taken from separate test vessels without fish at the start and end of the 0 to 24 and 72 to 96 hour test periods in order to assess the stability of exposure concentrations.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test material comprises many chemical components, some with low water solubility. To avoid negative physical effects of undissolved or emulsified test material on the organisms, the test was carried out with aqueous extracts prepared in dechlorinated tap water.
A preliminary WAF-study concerning the duration of stirring of the WAFs was carried out to determine the time required to achieve optimal equilibrium of the test material in the WAFs. Quantitation of dissolved component concentrations was achieved by GCMS and TOC analysis. The preliminary WAF-study resulted in a mixing period of 48 hours and a settling period of 1 hour being recommended.

- Method: The WAFs were prepared by stirring 100 mg/L of the test material in de-chlorinated tap water for 48 hours with a magnetic stirrer. The extractions were carried out in 20 L solid-glass fish tanks equipped with a glass tube that allowed the separation of the water phase by siphoning. The mixing was carried out at a speed that was slow enough not to cause dispersion or emulsification of the undissolved parts of the test material. To ensure this, the surface vortex developed by stirring was set at ~ 10 % of the total depth of the water. After stirring for 48 hours the solutions were allowed to stand for 1 hour to allow phase separation.
The WAFs were prepared at the 100 mg/L loading rate in 20 L solid glass fish tanks and replenished after each successive 24 hour exposure period. Preparation of the WAFs began on the day prior to being used in the test. WAFs obtained using this method were clear.
- Controls: The control media (dechlorinated tap water) was treated in the same way as the WAFs concerning duration of stirring, phase separation and siphoning.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra Fish (Danio rerio), Teleostei, Cyprinidae
- Length at study initiation: 3.0 to 3.5 cm
- Feeding during test: No.

ACCLIMATION
- Acclimation period: > 12 days.
- Acclimation conditions: Yes. The animals were kept in a climate-controlled room with 14 hours light to 10 hours dark; illumination was from Gro-Lux fluorescent tubes.
- Health during acclimation (any mortality observed): Mortality < 1 % (nominal value ≤5 %).

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Total hardness: 9.0 °dH
Carbonate hardness: 7.0 °dH

Test temperature:

23 ± 2 °C

pH:

8.0 to 8.6

Dissolved oxygen:

70 to 95 %

Nominal and measured concentrations:

100 mg/L loading rate WAF

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 L solid glass fish tanks
- Renewal rate of test solution (frequency/flow rate): renewed every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: De-chlorinated tap water
- Metals: Hg/Cd/Pb/Cu/Ni < 0.001 mg/L
- Nitrate: 4.4 mg/L
- Nitrite: <0.005 mg/L
- Ammonium: <0.01 mg/L

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 14 hours light to 10 hours dark; illumination was from Gro-Lux fluorescent tubes.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Shoaling behaviour, activity, balance, surfacing, mortalities, breathing frequency and apathy.

TEST CONCENTRATIONS
- Test concentrations: Limit test at 100 mg/L nominal loading rate WAF.

Reference substance (positive control):

no

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)

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- No mortality was observed throughout the 96 hour exposure period in the control or test group.
- All fish showed normal behaviour throughout the testing period and no sub-lethal effects could be observed.
- Observations carried out after the exposure period showed all fish to feed immediately upon provision of food and furthermore, still no sub-lethal effects were seen.

Sublethal observations / clinical signs:

Table 1 Concentration Analysis (TOC in mg/L) of the Control and Test Loading Rate at Various Observation Times

Period	Control	100 mg/L
Beginning of 0 to 24 hour period	3.2	6.9
End of 0 to 24 hour period	3.4	5.3
Beginning of 72 to 96 hour period	1.9	7.2
End of 72 to 96 hour period	1.7	6.3

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study, the 96 hour LL50 was determined to be > 100 mg/L and the NOELR to be 100 mg/L based on exposure to a WAF of the test material. No classification of the test material is required in accordance with EU criteria.

Executive summary:

A limit test was carried out to assess the acute toxicity potential of the test substance to Danio rerio in accordance with the standardised guideline OECD 203 under GLP conditions. The fish were exposed to a 100 mg/L loading rate water accomodated fraction (WAF) of the test material for 96 hours under semi-static conditions. The test fish were observed for mortality and any sub-lethal and behavioural effects. No mortality was seen throughout the test period, nor were any sub-lethal effects noted. Under the study conditions, the 96 hour LL50 was determined to be > 100 mg/L based on exposure to a WAF of the test substance (Aniol, 2006).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. Study read-across from supporting substance.

Qualifier:

according to guideline

Guideline:

other: Methods for measuring the acute toxicity of effluents to freshwater and marine organisms, 4th ed. US EPA/600/4-90/027

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

other: Methods for aquatic toxicity identification evaluations. Phase I toxicity characterization procedures, 2nd ed. US EPA/600/6-91/003.

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

The deviations were that fish received a single administration of food after 48 hours and the oxygen saturation concentration need only be >40 % to satisfy the EPA guidelines. These deviations were not considered to have adversely affected the validity of the study.

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

Test solutions were prepared by dissolving individual the test material in moderately hard reconstituted water (MHRW).
Stock solutions were prepared by dissolving 10 000 mg/L in MHRW and serially diluting with MHRW to develop a series of test concentrations spaced on a 0.5 x dilution factor (i.e., 10 000, 5000, 2500 and 1250 mg/L).

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: fathead minnows
- Strain: Pimephales promelas
- Source: All organisms used in testing were obtained from in-house cultures (ENSR, Fort Collins, CO, USA)
- Age at study initiation: 1 to 7 days old
- Feeding during test: 100 µL of concentrated brine shrimp nauplii was added after 48 hours of exposure (solutions were not subsequently renewed)

ACCLIMATION
Fathead minnow brood stock were cultured at 20 to 25 °C in tap water that was pre-treated with activated carbon. Eggs and larva were held in MHRW; larvae were fed brine shrimp nauplii (Artemia sp.) twice daily until they were used in testing.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

none

Test temperature:

25 °C

pH:

Measured pH was between 7.5 and 9.0.

Dissolved oxygen:

Measured DO concentrations were always within an acceptable range (>40 % saturation).

Nominal and measured concentrations:

Nominal concentrations of 1250, 2500, 5000 and 10 000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 30 mL plastic beakers
- Material, size, headspace, fill volume: 10 mL of test solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: moderately hard reconstituted water

OTHER TEST CONDITIONS
- Photoperiod: 16 hours of light with 8 hours of darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): daily observations of mortality. The criteria for death were no visible movement and no response to prodding.

Reference substance (positive control):

yes

Remarks:

Sodium Chloride

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

880 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % confidence limits 750 to 1020 mg/L. The arithmetic mean is for n = 3.

Details on results:

The 24 hour LC50 was 950 mg/L (95 % confidence limits 750 to 1090 mg/L) calculated as an arithmetic mean where n = 3.
The 48 hour LC50 was 910 mg/L (95 % confidence limits 750 to 1090 mg/L) calculated as an arithmetic mean where n = 3.

Results with reference substance (positive control):

The 96 hour LC50 for sodium chloride was 6390 mg/L (95 % confidence limits 6020 to 7070 mg/L) calculated as an arithmetic mean where n = 3.

Reported statistics and error estimates:

The LC50 concentration was calculated using a computer program following the trimmed Spearman–Karber method.

Validity criteria fulfilled:

not specified

Conclusions:

Under the conditions of this study, the 96 hour LC50 was 880 mg/L (95 % confidence limits 750 to 1020 mg/L). Therefore no classification is required in accordance with EU criteria.

Executive summary:

The acute toxicity potential of the test substance to Pimephales promelas was investigated in a 96 hour static procedure conducted in accordance with the guidance of the US EPA and in line with the general principles of the standardised guideline OECD 203. Fish were exposed to the test substance at concentrations of 0, 1250, 2500, 5000 and 10000 mg/L and were examined daily for mortality. Under the conditions of this study, the 96 hour LC50 was 880 mg/L (Mount, 1997).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

This endpoint was addressed using a read across approach to structural analogue distilled tall oil. Two key studies are provided, one on distilled tall oil and one on potassium chloride. It is considered that the data submitted provides an adequate reflection of the test substance.

Distilled tall oil:

A limit test was carried out to assess the acute toxicity potential of the test substance to Danio rerio in accordance with OECD Guideline 203 under GLP conditions. The fish were exposed to a 100 mg/L loading rate water accomodated fraction (WAF) of the test substance for 96 hours under semi-static conditions. The test fish were observed for mortality and any sub-lethal and behavioural effects. No mortality was seen throughout the test period, nor were any sub-lethal effects noted. Under the study conditions, the 96 hour LL50 was determined to be > 100 mg/L based on exposure to a WAF of the test substance (Aniol, 2006).

Potassium chloride:

The acute toxicity potential of the test substance to Pimephales promelas was investigated in a 96 hour static procedure conducted in accordance with OECD Guideline 203. Fish were exposed to the test substance at concentrations of 0, 1250, 2500, 5000 and 10000 mg/L and were examined daily for mortality. Under the conditions of this study, the 96 hour LC50 of potassium carbonate was 880 mg/L (Mount, 1997).