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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
From 2019-01-04 to 2019-01-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
See QMRF and QPRF in "attached background material" section.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
QSAR model
Qualifier:
equivalent or similar to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
yes
Remarks:
QSAR model
Principles of method if other than guideline:
The acute toxicity to the daphnids was determined using a calculation method for the Mechanism of Action (MechoA) in question (non-polar narcosis). The QSAR model is based on validated data for a training set of 58 chemicals derived from 48-hour test
on daphnids, for which the concentrations of the test item had been determined by chemical analyses over the test period.
GLP compliance:
no
Specific details on test material used for the study:
None.
Analytical monitoring:
no
Remarks:
Not applicable. See "any other information on material and methods incl. tables"
Details on sampling:
No data.
Vehicle:
no
Details on test solutions:
Not applicable.
Test organisms (species):
Daphnia sp.
Details on test organisms:
Results from the following species were used in the regression: Daphnia magna, Daphnia pulex
Test type:
other: QSAR model. See "details on test conditions"
Water media type:
not specified
Total exposure duration:
48 h
Remarks on exposure duration:
Results from a test duration of 48 hours only were used
Post exposure observation period:
Not applicable.
Hardness:
Not applicable.
Test temperature:
Not applicable.
pH:
Not applicable.
Dissolved oxygen:
Not applicable.
Salinity:
Not applicable.
Conductivity:
Not applicable.
Nominal and measured concentrations:
Not applicable.
Details on test conditions:
Calculation method.
Reference substance (positive control):
not required
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
12 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on typical composition
Details on results:
Not applicable.
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
Not applicable.

Determination of the Analytically Measurable Aqueous Phase (AMAP).

Using the model, the specific concentration of each constituent in the WAF can be accurately determined at any loading rate taking into account the original composition of the mixture and the new corrected limit of solubility of each constituent. The sum of these concentrations, the AMAP, is equivalent to the concentration of all constituents that would be measured in a WAF test. For a given loading rate, the loaded concentration of each constituent is compared to its respective solubility limit. If one is higher than the solubility limit then it is considered that the concentration of the constituent will be equal to its solubility limit. If lower, the true loading concentration is considered. Provided this adapted water solubility limits for each consitutents. analytically measurable concentrations in aqueous solutions expected from known WAF loading rates of characterised mixtures can be calculated. The AMAP expected at the EL50 is given below:

Analytically Measured Aqueous Phase (AMAP) calculated at the predicted EL50.

constituents

concentration in the WAF (mg.L-1)

Constituent 1

6.64

Constituent 2

0.722

Constituent 3

0.108

Constituent 4

0.0945

Constituent 5

3.32E-05

Constituent 6

6.41E-06

Constituent 7

0.126

Constituent 8

5.31E-03

Constituent 9

0.183

Constituent 10

6.84E-04

 

Validity criteria fulfilled:
yes
Conclusions:
The following toxicity value has been predicted for the registered substance: 48h-EL50 = 12 mg/L.
Executive summary:

A calculation method prediction was performed to assess the acute toxicity to Daphnia sp. of the test item, OLIBANUM OIL (Bowsellia papyrifera), using the WAF method. This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the Guideline for Testing of Chemicals No. 202, "Daphnia sp., Acute Immobilisation Test", referenced as Method C.2 of Commission Regulation No. 440/2008 adapted for testing of a mixture using the WAF method. The criterion predicted was the median effective loading rate of the mixture EL50 (Median Effect Loading), a statistically derived loading rate which is expected to cause immobility in 50% of test animals within a period of 48 hours.

The results below is the acute toxicity value anticipated during a 48-hour EL50study on daphnids based on the WAF method.The 48-hour EL50is calculated as follows:

 

Composition

Time (h)

EL50(mg test item.L-1)

typical

48

12

 

Description of key information

The following toxicity value has been estimated for the registered substance:48h-EL50 = 12 mg test item/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
12 mg/L

Additional information

For that endpoint, one reliable study was available: an in-house calculation method that replaces an OECD 202 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). A typical composition of the substance has been investigated.The algorithm used for the purpose of this study is based on a QSAR model which has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004).

A calculation method prediction was performed to assess the acute toxicity to Daphnia sp. of the test item, OLIBANUM OIL (Bowsellia papyrifera), using the WAF method. This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the Guideline for Testing of Chemicals No. 202, "Daphnia sp., Acute Immobilisation Test", referenced as Method C.2 of Commission Regulation No. 440/2008 adapted for testing of a mixture using the WAF method. The criterion predicted was the median effective loading rate of the mixture EL50 (Median Effect Loading), a statistically derived loading rate which is expected to cause immobility in 50% of test animals within a period of 48 hours.

The results below is the acute toxicity value anticipated during a 48-hour EL50study on daphnids based on the WAF method.The 48-hour EL50is calculated as follows:

Composition

Time (h)

EL50(mg test item.L-1)

typical

48

12