Tall oil, compd. with triethanolamine

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 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.

Justification for type of information:

Read across justification is attached in section 13.

Reason / purpose for cross-reference:

read-across source

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 % ASV

Nominal and measured concentrations:

0 (control) and 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)

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.

Reported statistics and error estimates:

No toxic effects were observed in the test and therefore statistical analysis of the results was not required

Sublethal observations / clinical signs:

Table 1. Test results - percentage mortality for each observation period

Period	Control	100 mg/L
0-24 h start	0	0
0-24 h end	0	0
24-48 h start	0	0
24-48 h end	0	0
48-72 h start	0	0
48-72 h end	0	0
72-96 h start	0	0
72-96 h end	0	0

Table 2. Results of TOC analysis of test media (mg/L)

Period	Control	100 mg/L
0-24 h start	3.2	6.9
0-24 h end	3.4	5.3
72-96 h start	1.9	7.2
72-96 h end	1.7	6.3

Concentrations of Total Organic Carbon (TOC) were determined in the fresh and old Control media and 100 mg/L WAFs at the start and end of the first and last 24 hour exposure period. The measured TOC concentrations ranged between 1.7 and 3.4 mg/L in the Control media and 5.3 and 7.2 mg/L in the 1000 mg/L WAFs.At observation periods 0 – 24 h and 72 – 96 h TOC-values of the Control were relatively stable (within ± 11 %) of initial values. TOC-values in the 100 mg/L WAFs slightly decreased at observation periods 0 – 24 h (23 %) and 72 – 96 h (13 %).

Table 3. Results of GCMS analysis of test media (mg/l)

Vessel	Period	9-Octa-decenoic acid	9,12-Octa-decadienoic acid	Abietic acid	3-Carene	Terpinole	Total
Control	0-24 h start	0,0064	0,014	0,0060	0,00053	0,00054	0,027
Control	0-24 h end	0,0064	0,014	0,0060	0,00053	0,00054	0,027
100 mg/L	0-24 h start	0,0064	0,014	0,0060	0,00053	0,00054	0,027
100 mg/L	0-24 h end	0,0064	0,014	0,018	0,00053	0,00054	0,039
Control	72-96 h start	0,0064	0,014	0,014	0,00053	0,00054	0,036
Control	72-96 h end	0,0064	0,014	0,021	0,00053	0,00054	0,043
100 mg/L	72-96 h start	0,022	0,014	0,21	0,00053	0,00054	0,25
100 mg/L	72-96 h end	0,0064	0,014	0,15	0,00053	0,00054	0,17
Detection Limit		0,0064	0,014	0,0060	0,00053	0,00054

Remark: Quantitative GCMS-values are based on results and/or limits of detection

Concentrations of GCMS-detected components in the Control were below detection limits at start and end of observation period 0 – 24 h. Traces of Abietic acid could be found at start and end of observation period 72 – 96 h. This was probably due to slight residues of Abietic acid in the gas chromatograph and/or from the glass vessels that were used for preparation of the Water Accommodated Fractions.

Concentrations of GCMS-detected components at test loading rate 100 mg/L were below detection limits at the start and end of observation period 0 – 24 h, with the exception of Abietic acid that could be found in traces at the end of this observation period. Traces of 9-Octadecenoic acid could be found at the start of observation period 72 – 96 h. At the end of this observation period concentration of 9-Octa-decenoic acid had decreased below the detection limit (0.0064 mg/l). The decrease was probably caused by biodegradation of this component. Traces of Abietic acid also could be found at the start and end of observation period 72 – 96 h. Total concentrations of GCMS-detected components increased (44 %) during observation period 0 – 24 h and decreased (32 %) during observation period 72 – 96 h.

GCMS concentrations were lower compared to TOC concentrations. This was to be expected because the GCMS-analysis only quantified selected components of the test substance whereas TOC-analysis obtains a sum parameter for all dissolved organic components.

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 material 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 WAF of the test material for 96 hours under semi-static conditions. Fish were observed for any effects on mortality and additionally for any sub-lethal and behavioural effects.

No mortality was seen throughout the test period, nor were any sub-lethal effects noted.

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.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Test date: 20th January 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

USEPA Ecotox Database evaluation: Reliability: 2A: “Remarks: Reliable with restrictions; Acceptable, well-documented publication report which meets basic scientific principles”

Justification for type of information:

Read across justification is attached in section 13.

Principles of method if other than guideline:

Guideline: Not specified.

GLP compliance:

not specified

Specific details on test material used for the study:

Purity 97%

Analytical monitoring:

yes

Remarks:

Gas-Liquid Chromatography

Vehicle:

not specified

Details on test solutions:

Toxicant Stock: 90.4 g/L Diluted (Stirred)

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead Minnow
- Age at study initiation (mean and range, SD): 30 d
- Length at study initiation: 18.1 mm (mean); 0.788 mm (SD)
- Weight at study initiation: 0.083 g (mean); 0.0083 g (SD)
- Loading: 0.1153 g/L/d
- Source: Cultured at the U.S. EPA Environmental Laboratory-Duluth or the University of Wisconsin-Superior campus (both used identical culturing methods).

Test type:

not specified

Water media type:

freshwater

Total exposure duration:

96 h

Hardness:

Not given

Test temperature:

25.7°C

pH:

7.8

Dissolved oxygen:

7.3 mg/L

Salinity:

n/a

Conductivity:

Not given

Nominal and measured concentrations:

Nominal: Control (0 g/L); 7.30, 11.2, 17.3, 26.6 and 40.9 g/L

Details on test conditions:

- Five water quality parameters routinely measured (water temperature, dissolved oxygen, total hardness, total alkalinity and pH).
- Tank volume: 1 L

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 11.8 g/L

Nominal / measured:

meas. (not specified)

Basis for effect:

mortality (fish)

Remarks on result:

other: Conf. Lim: 10.6-13.0 g/L

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

7 300 mg/L

Nominal / measured:

meas. (not specified)

Basis for effect:

mortality (fish)

Details on results:

Affected fish lost schooling behaviour, were hypoactive and darkly coloured, had increased respiration and lost equilibrium prior to death. Hardness and alkalinity values were not recorded. Samples were not taken at 96 h for determination of toxicant concentrations. The pH of the stock solution was adjusted to that of lake water using HCl.

Sublethal observations / clinical signs:

	Toxicant Concentrations (g/L)
Date	Control	A	B	C	D	E
Nominal:	0	7.3	11.2	17.3	26.6	40.9
01/20/87	<0.02	6.42	10.4	16.2	26.4	41.8
01/21/87	<0.02	6.21	10.2	16.2	25.8	40.1
01/22/87	<0.02	6.53	10.7	16.4	27.0	40.7
01/23/87	<0.02	7.16	11.0	17.1	25.6	40.9
01/24/87
Average	<0.02	6.58	10.6	16.5	26.2	40.9
Cor Ave	<0.02	6.14	9.86	15.4	24.4	38.1
Percent Recovery	107.2 (3.8) N=4

	Mortalities
Hour	Control	A	B	C	D	E
Initial	20	20	20	20	20	20
24			1	15	20	20
48			3	17	20	20
72			4	18	20	20
96			4	18	20	20

	Effects
Hour	Control		B	C	D	E
Initial	20	20	20	20	20	20
24			1	15	20	20
48			3	17	20	20
72			4	18	20	20
96			4	18	20	20

Validity criteria fulfilled:

not specified

Conclusions:

In a study conducted with Pimephales promelas the 96 h LC50 was calculated to be 11.8 g/L. The following results were obtained:
96 h LC50 = 11.8 g/L (Conf. Lim. 10.6-13.0 g/L)
96 h NOEC 7300 mg/L

Executive summary:

In a study conducted with Pimephales promelas the 96h LC50 was calculated to be 11.8 g/L. The study was considered to be well documented and to meet generally accepted scientific principles, and should be considered acceptable for assessment.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Description of key information

The acute toxicity of the target substance, Tall oil, compound with triethanolamine, to fish, was assessed by read-across from its components, distilled tall oil & triethanolamine. Based on read-across data, the target substance is not expected to be hazardous to fish, with the lowest measured 96 -h LL50 > 100 mg/L. The read-across justification document covering this and other endpoints is attached in Section 13.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L