Fatty acids, tall-oil, iron salts

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:

2006-02-06 - 2006-03-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for read-across, see attached file.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Part 2

GLP compliance:

yes

Analytical monitoring:

yes

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna (Crustacea, Daphniidae), Clone 5 Origin: German Environmental Ministry, Berlin Pre-treatment: the animals are cultivated in a climate-controlled room (light/dark = 14 h/10 h; illumination: Gro-Lux fluorescent tubes). The animals are fed with algae (Desmodesmus subspicatus).

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Details on test conditions:

Definite Limit-Test:
Animals: 10 animals both in the control and test loading rate 1 mg/L; each animal was kept in a separate 150 mL glass beaker, including 100 mL test water
Duration: 21 d, semistatic
Temperature: 20 ± 2 °C (Incubator)
Illumination: 16 h light, 8 h dark (Gro-Lux fluorescent tubes)
Aeration: none
Feeding: daily with algae (Desmodesmus subspicatus), providing 0,1-0,2 mg C/L and Daphnia per day
Water: Stock solutions in deionised water: CaCl2 x 2 H2O: 11,76 g/L KCl: 0,23 g/L MgSO4 x 7 H2O: 4,93 g/L NaHCO3: 2,59 g/L
25 ml aliquots of each stock solution were mixed and then topped up to 1 L with deionised water. The water was aerated until the concentration of oxygen complied with the saturation value of atmospheric oxygen. The total of Ca- and Mgions was 2,5 mmol/L, the ratio of Ca/Mg was 4:1, the ratio of Na/K was 10:1. The total alkalinity of the solution was 0,8 mmol/L, the pH-value was 7,80,2.
Hardness of the Culturing medium: 231 ppm (as CaCO3); according to OECDGuideline 202, Part 2 a hardness of > 140 ppm (as CaCO3) is recommended.
TOC (Total Organic Carbon) of the Culturing medium: 0,23 mg/L; according to OECD-Guideline 202, Part 2 a TOC of < 2 mg/L is recommended.

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

1 mg/L

Details on results:

Water Accommodated Fractions (WAFs) of crude tall oil Sample 3 caused no chronic toxic effects on Daphnia magna in a reproduction test conducted in accordance with OECD-Guideline 202, Part 2. A NOELR of 1 mg/L was determined.

Conclusions:

NOELR: 1 mg/L (NOELR = No Observable Effect Loading Rate)

Executive summary:

Aim: Determine if crude tall oil showed any chronic toxic effects on Daphnia magna in reproduction test OECD 202 part 2.

Method: In the Daphnia Reproduction Test as Limit-Test, Daphnia, aged < 24 h at the beginning of the test, are exposed to a test loading rate of 1 mg/L under defined conditions over a period of 21 d.

Results:

NOELR: 1 mg/L (NOELR = No Observable Effect Loading Rate)

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

See attachement for read-across

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

1 mg/L

Remarks on result:

other: Tall oil

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

910 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 2-EHA

Details on results:

Water Accommodated Fractions (WAFs) of crude tall oil Sample 3 caused no chronic toxic effects on Daphnia magna in a reproduction test conducted in accordance with OECD-Guideline 202, Part 2. A NOELR of 1 mg/L was determined.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from reliablesource. Though no test report is available at present the data from this source are known to be well documented and the test are performed according to GLP and OECD guidelines.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Remarks:

probably: yes

Analytical monitoring:

yes

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

Test organism
The recommended species is Daphnia magna, but other Daphnia species such as Daphnia pulexs may also be used.
Use organisms that are 24 hr old or younger at the beginning of the exposure. To reduce variation, do not use the first offsprings of the parents. The test organisms must be obtained from healthy parents (i.e., showing no sign of stress under the culture conditions such as a high mortality, the appearance of males or oostegites, a prolonged period before the first offsprings and discoloration) of the same strain.
The parent organisms must be cultured under conditions (light, temperature and water) as same as those employed in the test. When performing the test using water different from that usually used for culturing Daphnia spp., establish an acclimatization period before beginning the exposure. The acclimatization can be performed by culturing the organisms in the material water at the test temperature for at least 48 hr before beginning the exposure. Use the offsprings obtained from acclimatized parents for the test.

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Details on test conditions:

The following test vessel and equipment are used for the study.

Test vessel
The test vessel or other instrument that contacts the test solution must be made of glass or other chemically inert materials. Cap the vessel loosely to prevent evaporation and dust contamination.
If the test substance is volatile, perform the test in a sealed system. Use a sufficiently large vessel to prevent shortage of dissolved oxygen.

Instrument
Use a dissolved oxygen meter (a microelectrode or other instrument suitable for measuring the dissolved oxygen concentration with a small amount of sample), a pH meter, an appropriate instrument for controlling temperature, etc., for the test.


Material water
Use water suitable for culturing and testing Daphnia spp. It can be natural water (surface water or groundwater), dechlorinated tap water or artificially prepared water (e.g., Appendix Table 1), but must satisfy the conditions listed in Appendix Table 2.
Do not use Elendt M4 or M7 media or water containing chelating agents for testing metal-containing substances. The water hardness should be 250 mg/L or smaller in terms of calcium carbonate concentration, and the pH should be 6-9.
Aerate the material water before using it for the test.


Test solution
To prepare a test solution of each concentration, directly dissolve the required amount of the test substance in the material water, or prepare a stock solution of the test substance at an appropriate concentration and dilute it with the material water. Follow the descriptions in "Preparation of the test solution" under "III. General rules".
Perform the test without adjusting the pH. If the pH of the material water is not within the range of 6-9, it is recommended to perform an additional test after adjusting the pH to that observed prior to the addition of the test substance. Perform the pH adjustment through a method causing no change in the concentration, chemical reaction or precipitation of the test substance. Preferably, use HCl or NaOH for the pH adjustment.


Test method
The test can be performed under a static, semi-static or flow-through condition. If the test substance concentration is unstable, a semi-static or flow-through test is recommended.

Exposure period
Perform the exposure period for 48 hr.

Volume and number of test organisms

Volume: Use at least 2 mL or the test solution per organism.
Number of test organisms: Use at least 20 organisms for each of the test concentrations and the control. Preferably, divide the organisms into 4 groups of 5 organisms.

Test concentrations
Adopt a concentration range comprising at least 5 concentrations that are setup in a geometric progression, preferably at a geometric ratio of within 2.2. The highest test concentration preferably induces 100% immobilization, but concentrations of 100 mg/L or higher do not need to be tested. Preferably, no effect is observed at the lowest concentration.
Perform a control, and additionally an auxiliary control if using any auxiliary.

Culture method

Illumination: The photoperiod is preferably set to 16 hr light and 8 hr dark. The test can be conducted in dark if the test substance is unstable against light.
Temperature: The temperature is set within the range of 18°C - 22°C, with variations among the test vessels of ± 1.0°C.
Dissolved oxygen concentration: It must be kept at 3 mg/L or higher. In principle, do not perform aeration during the exposure period.
Feeding: Do not feed the organisms.

Beginning of the exposure to the test substance
Start the exposure by transferring a specified number of organisms established in 5-3. to each test vessel.

Observation
Observe the mobility of the organisms at least twice, i.e., at 24 and 48 hr after the beginning of the exposure. The organisms are considered as being immobilized when they do not move for 15 sec after the test vessel is gently shaken. During observation, record any anomaly in behavior or appearance besides immobilization.

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

910 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Description of key information

The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance.

Additional information

Reaction mass of Fatty acids, tall oil, 2-ethylhexanoic acid and magnesium salts, based on the read-across results from both tall oil and 2 -EHA show a 21 day NOELR value of 1 mg/L and a 48h EC50 value of 910 mg/L.