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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
calculation (if not (Q)SAR)
Remarks:
Estimated by calculation
Adequacy of study:
key study
Study period:
2017-03-16 to 2017-03-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Remarks:
Calculation method is used; calculation method applicable for the endpoint
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
calculation method
Principles of method if other than guideline:
The first step of the iSafeRat mixture toxicity calculation employs phase equilibrium thermodynamics in order to determine the concentrations of each constituent within the WAF. This fraction equates to the analyzable fraction of a WAF study.
Within the WAF, the constituents also partition between themselves further reducing the bioavailable fraction and thus the toxicity of the mixture compared to the individual constituents. In the calculation the second step is to remove this non-bioavailable fraction.
The final step is to determine the truly bioavailable fraction of the WAF per constituent. The EC50s of each constituent are already known from literature or calculated using the iSafeRat QSAR model. Each value and calculation has been included as a supporting study in the IUCLID. An additivity approach (based on Chemical Activity of each constituent) is used in order to calculate the Effective Loading rate of the WAF.
The method has been validated using data derived from 48-hour EC50 tests on aquatic invertebrates, for which the concentrations of the test item had been determined by chemical analyses over the test period. Further to this the effective loading rate of the WAF is determined by using a series of calculation steps using phase equilibrium thermodynamics and excluding the non-bioavailable fraction.
GLP compliance:
no
Specific details on test material used for the study:
not applicable
Analytical monitoring:
no
Details on sampling:
not applicable
Vehicle:
no
Details on test solutions:
not applicable
Test organisms (species):
Daphnia sp.
Details on test organisms:
not applicable
Test type:
other: calculation method
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
48h-EL50 (effective loading rate of WAF)
Post exposure observation period:
not applicable
Hardness:
Hardness is not a necessary component of the WAF calculation
Test temperature:
The Temperature is not a necessary component of the WAF calculation.
pH:
The pH is not a necessary component of the WAF calculation
Dissolved oxygen:
The oxygen concentration is not a necessary component of the WAF calculation
Salinity:
Salinity is not a necessary component of the WAF calculation.
Nominal and measured concentrations:
The calculation determines measured concentrations
Details on test conditions:
calculation method
Reference substance (positive control):
not required
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
17 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on the typical composition of lavandin oil grosso
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
14 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on the typical composition of lavandin oil abrial
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
16 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on the typical composition of lavandin oil super
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
15 mg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on the typical composition of lavandin oil sumian
Details on results:
not applicable
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
no data

At this 48-hour EL50 the expected concentrations of each constituent in the mixture (based on thermodynamic calculation) are as follows (for the four qualities of lavandin oil):

 

concentration in the WAF (mg.L-1)

constituents

GROSSO

ABRIAL

SUPER

SUMIAN

linalool

5.4

4.5

4.1

6.3

linalyl acetate

5.1

3.2

6.3

2.9

camphor

1.4

1.2

0.74

0.94

cineol 1,8

1.2

1.2

0.63

1.2

terpinene-1-ol 4

0.63

0.12

0.063

0.061

borneol laevo

0.52

0.32

0.36

0.84

lavandulyl acetate

0.45

0.19

0.21

0.030

β-caryophyllene

0.0021

0.0010

0.0020

0.0016

α-terpineol

0.21

0.10

-

0.13

β-farnesene

0.00058

-

0.00040

0.00042

β-ocimene

0.072

0.39

0.22

0.37

limonene

0.11

0.10

-

0.066

myrcene

0.040

0.032

-

-

octan-3-one

-

-

0.13

-
Validity criteria fulfilled:
yes
Conclusions:
48h-EL50 for the typical composition of Lavandin Oil grosso = 17 mg test item/L.
48h-EL50 for the typical composition of Lavandin Oil abrial = 14 mg test item/L.
48h-EL50 for the typical composition of Lavandin Oil super = 16 mg test item/L.
48h-EL50 for the typical composition of Lavandin Oil sumian = 15 mg test item/L.
Executive summary:

Lavandin Oil is a Natural Complex Substance (UVCB) with four different qualities (grosso, abrial, super and sumian) that have well-defined compositions. The acute toxicity of lavandin oil to aquatic invertebrate has been investigated using an in-house calculation method that replaces an OECD 202 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). The typical compositions of the four qualities of the substance lavandin oil have been investigated.

The first step of the iSafeRat mixture toxicity calculation employs phase equilibrium thermodynamics in order to determine the concentrations of each constituent within the WAF. This fraction equates to the analysable fraction of a WAF study. In the calculation the second step is to remove this non-bioavailable fraction. Within the WAF, the constituents also partition between themselves further reducing the bioavailable fraction and thus the toxicity of the mixture compared to the individual constituents.

The final step is to determine the truly bioavailable fraction of the WAF per constituent. The EC50s of each constituent were predicted using the iSafeRat QSAR model. Each value has been included as a supporting study in the IUCLID. An additivity approach (based on Chemical Activity of each constituent) is used in order to calculate the Effective Loading rate of the WAF.

The 48-h EL50 of the four qualities of Lavandin oil were 17, 14, 16 and 15 mg test material/L for the typical compositions of lavandin oil grosso, abrial, super and sumian respectively. For that endpoint, the most conservative value is selected for the registered substance lavandin oil and corresponds to a 48h-EL50 of 14 mg/L.

Based on the results of this study, Lavandin oil would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.

This toxicity study is acceptable and can be used for that endpoint.

 

Results Synopsis

Test Type: Calculation method

48h-EL50: 14 mg test material/L based on typical composition of lavandin oil abrial (most conservative value amongst the four qualities of lavandin oil)

Description of key information

Two reliable studies were available to assess the acute toxicity of LAVANDIN OIL to aquatic invertebrates:

- one test performed according to OECD 202 guideline and under GLP compliance that gives a 48h-EL50 of 21.407 mg/L.

- a calculation method that replaces an OECD 202 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions) that gives a 48h-EL50 of 14 mg/L (most conservative result amongst the four qualities of lavandin oil and based on the typical compositions).

The two studies are reliable and the geometric mean of the two results could have been taken as the key value for that endpoint. However, the experimental study was performed on only one quality, which is the most common quality for the registered substance lavandin oil. On the other hand, the calculation method gave results for the four qualities of the registered substance lavandin oil. Therefore, it has been decided to select the most conservative result from the calculation method as the key value for that endpoint, in order to encompass all qualities of the registered substance.

Therefore, the key EL50 value for that endpoint is 14 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
14 mg/L

Additional information

The experimental study has been realised based on the most common quality of lavandin oil: lavandin oil grosso.

The in-house calculation method gave a prediction for the four qualities of lavandin oil (grosso, abrial, super and sumian) in order to select the most conservative result for lavandin oil.

When results for lavandin oil grosso of the experimental study and of the calculation method are compared, it appears that the calculation method gives an accurate prediction although being slightly more conservative than the test result. Indeed, lavandin grosso EL50 = 21.407 mg/L in the experimental study and 17 mg/L in the calculation method.

Therefore, this calculation method can be considered as valid to be used alone for other ecotoxicological endpoints.

Synopsis:

Test item: LAVANDIN OIL

48h-EL50: 14 mg test material/L