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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11.03.2021 - 18.03.2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test substance: Santalene Oil
- Test substance No.: 20/0058-1
- EC No.: 950-969-7
- Batch identification: 1906PD01SENoil0
- Purity: 99.98g/100g
- Homogeneity: Given
- Storage stability: Expiry Date: 19.06.2021
- Physical state/appearance: Liquid/colorless, clear
- Storage conditions: Refrigerator, under N2
Analytical monitoring:
yes
Details on sampling:
Samples for concentration control analysis were taken from each freshly prepared solution (0 and 24 h) without daphnids, and at the end of each exposure interval (24 and 48 h) from all test vessels with daphnids, and from the additional abiotic replicates without daphnids (pooled replicates).
All samples were collected with a glass pipette and placed into 50 mL glass samples vials. For each concentration, two retained samples were taken at each time point.

Exactly 9 mL of each samples solution was mixed with 200 µL 1,4-dioxane and 100 µL ISTD 1.1. The mixtures were extracted using a laboratory shaker with 1 mL hexane for 1 hour. The hexane extracts were used for analysis.
Vehicle:
no
Details on test solutions:
TEST SUBSTANCE PREPARATION
The test substance is poorly soluble in water. Therefore, the test solutions were prepared following general guidance provided in OECD 23 to achieve a water accommodated fraction (WAF) of the test substance.
Each test solution was prepared separately (differential loading) by directly adding test substance to test medium.
Glass aspirator bottles (2-L) with a bottom side-outlet attached to a stopcock were filled with 2.2-L test media. For each test solution the test substance was pipetted carefully on the water surface, respectively. The bottles were closed and the solutions stirred on a magnetic plate for approx. 96 hours. The stirring was slow (approx. 100 rpm) so that no vortex was formed. The undissolved test substance should remain on the surface and the required volume of the saturated solution (approx. 700 mL) was removed from the bottom of the bottles and inspected visually for the presence of any undissolved test substance by observing the scattering of a laser light through the test solution (Tyndall effect).
Fresh test solutions were prepared daily and the test was performed in closed test vessels to maximize the exposure to all soluble components of the test substance.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Name: Daphnia magna STRAUS
- Age at study initiation (mean and range, SD): < 24 h
- Stage and instar at study initiation: First instar, at least 3rd brood progeny
- Method of breeding: Daphnia brood stock are kept in mass cultures consisting of approx. 20- 30 parthenogenetically reproducing females for a maximum of 4 weeks and fed live unicellular algae (Desmodesmus subspicatus), cultured continuously at the test facility. All individuals in each mass culture originate from a single female and are thus genetic clones. After approx. 14 days the adults have produced at least 3 broods and the young can be used in tests.
- Source: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Ecotoxicology Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
- Feeding during test: No

ACCLIMATION
- Acclimation conditions (same as test or not): The Daphnia are cultured under the identical conditions as the test including test media (Elendt M4), water quality and temperature (20 +/- 1°C)
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
2.27 mmol/L
Test temperature:
19.4 - 19.9°C
pH:
7.9
Dissolved oxygen:
5.5 - 7.9 mg/L
Conductivity:
556 µS/cm
Nominal and measured concentrations:
Nominal test concentration (loading concentration) [mg/L]: 0 (control), 4.6, 10.0, 22.0, 46.0, 100.0;
Mean measured test concentration [µg/L]: 0 (control), 11.0, 17.2, 35.0, 62.8, 103.3
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass flasks (50 mL nominal volume)
- Type (delete if not applicable): closed (sealed with ground glass stoppers)
- Volume of solution: approx. 50 mL
- Aeration: none
- Renewal rate of test solution: Daily renewal of test solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per abiotic (no organisms) control (replicates): 2
- Biomass loading rate: approx. 0.1
- Feeding: No feeding during the exposure period

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light: 8 hours darkness
- Light intensity: 157 - 671 lux at a wavelength of 400 - 750 nm

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Immobilization (mortality): daily
- Sublethal effects: daily

VEHICLE CONTROL PERFORMED: no
Reference substance (positive control):
yes
Remarks:
sodium chloride
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
Loading rate
Basis for effect:
other: Immobilization
Details on results:
- Behavioural abnormalities: -
- Observations on body length and weight: -
- Other biological observations: -
- Mortality of control: -
- Other adverse effects control: -
- Immobilisation of control: No immobile Daphnia were observed in the control over the test duration
- Abnormal responses: -

- Dissolution behavior: All of the test solutions were visibly clear and colorless after preparation and remained so after 24 and 48 hours of exposure in the test. No undissolved test substance was visible in the respective solutions and there were no other remarkable observations
Results with reference substance (positive control):
Reference substance tests are conducted monthly and according to OECD 202 guideline under GLP accordance (but without GLP status).

The EC50 (48h) of the reference substance sodium chloride was 4.90 g/L (experiment date: 24.02.2021, project number: 50E0789/12E067). This result is within the range of 3.88 - 7.22 g/L and indicates that the culture of Daphnia magna used in this study is responding normally to toxic stress.










































































































































Number of mobile Daphnids
Nominal concentration [mg/L]Number of mobile Daphnia at each observation period
Replicate 1 [h]Replicate 2 [h]Replicate 3 [h]Replicate 4 [h]
0244802448024480244824 h48 h
0 (control)5555555555552020
0.465555555555552020
1.05555555555552020
2.25555445555551919
4.65555555545552019
10.05325445555441615
Number of test animals per replicate: 5

 

Validity criteria fulfilled:
yes
Conclusions:
The 48h EC50 of Santalene oil in an acute toxicity test with Daphnia magna STRAUSS was >100 mg/L, based on the loading rates of the test item.
Executive summary:

In a 48-hour acute toxicity study, neonate Daphnia magna were exposed to Santalene oil at loading rates of 0 (control), 4.6, 10.0, 22.0, 46.0, 100.0 mg/L under daily-renewal conditions in accordance with the OECD 202 guideline. The water, pH, temperature and dissolved oxygen were within acceptable guideline specifications. Immobilization (mortality) and sublethal effects were observed daily.


The 48-h EC50 values determined in this acute toxicity study were:
 - >100.0 mg/L (based on the loading rates of the test item)


The measured concentrations deviated markedly from the loading rate. The test organisms were exposed to all soluble components of the test substance at the given loading rates under testing conditions.
The test substance is a UVCB and as such every constituent contribues to a different degree to overall solubility, depending on its own individual solubility and its mass fraction in the test substance. Thus, for an evaluation of the results the effect concentrations should be expressed based on the nominal loading rates andw ere considered to be an accurate represenation of exposure levels throughout the experiment.

Description of key information

In a 48-hour acute toxicity study, neonate Daphnia magna were exposed to Santalene oil at loading rates of 0 (control), 4.6, 10.0, 22.0, 46.0, 100.0 mg/L under daily-renewal conditions in accordance with the OECD 202 guideline. Immobilization (mortality) and sublethal effects were observed daily.


The 48-h EC50 values determined in this acute toxicity study were:
 - >100.0 mg/L (based on the loading rates of the test item)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
> 100 mg/L

Additional information