Oils, vegetable, deodorizer distillates

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Aug 2012 - 29 Aug 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

yes

Remarks:

At four days the measured soil temperature increased up to 23.1 °C at maximum for limited time intervals. However, test results have not been impacted.

Qualifier:

according to guideline

Guideline:

EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of mixing into soil: The test substance was poorly soluble in water, therefore a volatile organic solvent was used. The stock solution was prepared in acetone. The test substance was dissolved in an amount of acetone sufficient to prepare a stock solution. An appropriate amount of the stock solution was used to soak a portion of quartz sand of the artificial soil. After evaporation of the solvent by placing under a fume hood, the quartz sand was coated with the test substance. The test substance-coated fraction of the quartz sand was then incorporated into the remainder of the artificial soil by thoroughly mixing for approximately 5 min. The respective batches of treated test substrate were mixed by a portable drilling machine equipped with a stirring staff thoroughly to obtain homogeneous distribution of the test substance.
- Controls: blank and solvent control
- Evaporation of vehicle before use: yes, under fume hood

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: The earthworms used in this test were kept at ECT Oekotoxicologie GmbH since February 1994. They were originally delivered by Co. Landenberger (D-72355, Schoemberg)
- Age at test initiation and weight at test initiation: Only adult earthworms (with clitellum) with a fresh weight between 300 and 600 mg were used.

ACCLIMATION
- Acclimation period: Adult earthworms were selected out of the culture and acclimatised for at least 24 h in non-treated artificial soil

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test temperature:

20.0 - 23.1°C

pH:

5.8-6.0

Moisture:

49.5-51.3% of Water Holding Capacity (WHC)
41.1-42.6% of dry mass

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Test vessels were 1.7 L preservation jars, covered by perforated twist-off tops
- Amount of soil: 500 g dry weight per test vessel
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (artificial substrate): The composition of the artificial soil was based on OECD guideline 207 (for percentages refer to dry weight):
10% Sphagnum peat (no visible plant remains; finely ground and air-dried)
20% Kaolin-clay (kaolinite content > 30%)
69-70% Quartz sand (fine sand content with particles between 50 and 200 microns higher than 50%)
0.3-1% Calcium carbonate (CaCO3)
- Maximum water holding capacity (in % dry weigth): 40-60%
- Pretreatment of soil: The air-dried peat was shredded in a chaff-cutter. Afterwards, all parts of the artificial soil were mixed homogeneously. The pH value was adjusted to 6 ± 0.5 using calcium carbonate. The moisture content was adjusted to 40-60% of max WHC using deionised water. The water content of the artificial soil was determined by drying a small sample at 105°C.

OTHER TEST CONDITIONS
- Photoperiod: Permanent
- Light intensity: 523-604 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Number of dead adult earthworms after 7 and 14 d, body weight at the start of the test and after 14 d, morphology and behaviour after 7 and 14 d

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test

Nominal and measured concentrations:

1000 mg/kg artificial soil dry weight (nominal, limit test)

Reference substance (positive control):

yes

Remarks:

Chloroacetamide

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil ww

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: growth, morphology and behaviour

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: growth, morphology and behaviour

Details on results:

- No mortality was observed at the solvent control, blank control and the tested limit concentration of 1000 mg/kg dw
- The biomass of individual adults after 14 d was 90.4% of the initial weight in the solvent control, 91.7% in the control and 96.4% at 1000 mg test substance/kg artificial soil dry weight
- No other symptoms (morphological, behavioural) were observed

Results with reference substance (positive control):

LC50 (14 d) = 42.7 mg/kg (within the validity range given in the ISO Guideline 11268-1 (1997))

Reported statistics and error estimates:

Mortality was not evaluated statistically since no mortality was observed at the limit concentration tested. Biomass was not evaluated statistically since difference in biomass development between control and the limit concentration was 0.9% only.

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the nominal 14 d NOEC of the test substance to earthworms was >1000 mg/kg dw.

Executive summary:

A study was conducted to determine the short term toxicity of the test substance to earthworms according to OECD guideline 207 and EU method C.8. The test organisms were exposed to a limit concentration of 1000 mg/kg dw of the test substance admixed in soil and the mortality, growth, morphological changes and behaviour of the treated organisms were observed for 14 days post exposure. A solvent control, negative control and a positive control (chloroacetamide) were also kept simultaneously. The LC50 of the positive control was determined to be in the guideline-recommended range. Under the test conditions, the nominal 14 d NOEC of the test substance to earthworms was >1000 mg/kg dw (Moser, 2013).

Reference 2

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

No adequate short or long term toxicity study was available with the test substance. However, a 14 -d earthworm study conducted with the read-across substance 'glycerides, C14 -18 and C16 -18 -unsatd. mono-, di- and tri-‘ having similar chain length distribution as the glyceride constituents of ‘oils, vegetable, deodorizer distillates’ did not show any effects on mortality, growth, morphology and behaviour of the treated organisms. The nominal 14 d NOEC for these effects was established at ≥1000 mg/kg dw. Considering this information together with the ready biodegradability potential of the substance, low estimated BCF values for the major constituents (see section 4.3), toxicokinetic information from mammals as well as the metabolic potential of fish to break down tiglycerides to their constituent fatty acids which are then metabolised and used as source of energy (Tocher, 2003) all suggests that the ‘oils, vegetable, deodorizer distillates’ will not bioaccumulate.

Therefore, no toxicity to earthworms is expected and hence no further testing is considered to be required, in accordance with Annex IX, Section 9, Column 2 of the REACH legislation.