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Ecotoxicological information

Toxicity to terrestrial plants

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Administrative data

Endpoint:
toxicity to terrestrial plants: long-term
Remarks:
Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test on L(+) sodium potassium tartrate tetrahydrate
Study period:
PROVISIONAL TIMING Start of experimentation date: 03/10/2022 End of experimentation date: 25/11/2022 Draft final report date: 16/12/2022
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants, Growth Test)
Version / remarks:
19 July 2006
GLP compliance:
yes (incl. QA statement)

Test material

1
Reference substance name:
Reference substance 001
Cas Number:
6381-59-5
Test material form:
solid: particulate/powder
Remarks:
white
Details on test material:
Batch number 12001378620
Specific details on test material used for the study:
Details of reference item will be described in the final report

Sampling and analysis

Analytical monitoring:
yes
Remarks:
The temperature and relative humidity control, if relevant, will be recorded.

Test substrate

Vehicle:
no
Remarks:
The tests soils will be prepared by direct addition of test item solution into artificial soils.
Details on preparation and application of test substrate:
The test item solution will be mixed thoroughly with the soil substrate before introducing it into a test container.

Study design

Test type:
seedling emergence and seedling growth test
Study type:
laboratory study
Substrate type:
artificial soil
Remarks:
Sieved sphagnum peat will be mixed thoroughly with quartz sand and kaolin clay.
Limit test:
yes
Remarks:
If no toxicity does not show in the preliminary test, a limit test will be performed at 1905 mg test item / L. Otherwise, a complete test with a concentration range will be performed and a geometric series of at least five concentrations will be used.

Test conditions

Test temperature:
23 ± 3°C
Details on test conditions:
16:8 light:dark cycle
Nominal and measured concentrations:
In order to estimate the concentration range for the definitive test, a non-GLP preliminary test (RRCo-
001306_01) will be performed. The concentration tested in the preliminary test will be:
Level 1:
-Tartrate ion concentration (mg.kg-1): control
-Test item concentration (mg.kg-1): control
Level 2:
-Tartrate ion concentration (mg.kg-1): 10
-Test item concentration (mg.kg-1): 19.05
Level 3:
-Tartrate ion concentration (mg.kg-1): 100
-Test item concentration (mg.kg-1): 190.05
Level 4:
-Tartrate ion concentration (mg.kg-1): 1000
-Test item concentration (mg.kg-1): 1905

The range concentration for the definitive test will be defined according to the results of the preliminary
test.
Reference substance (positive control):
yes
Remarks:
Boric acid (CAS number: 10043-35-3)

Results and discussion

Details on results:
Emergence: % of emergence referred to plants that emerged after the application (0% corresponded to no
emergence and 100% corresponded to all of the plant emerged).
Survival: % of survival referred to the plants that survive after emergence (0% corresponded to no survival and
100% corresponded to all of the plant survived).
Biomass: Dry weight (unit [g]) of the harvested living plant material was measured at the end of the test by
harvesting the living shoot at the soil surface and drying at 60°C to constant weight.
Effects compared to the control: Emergence and dry weight in the test item treated group will be compared with the control group.

Endpoints (ECx with x=10, 20 or 50) and if applicable their respective confidence limits will be obtained
by non-linear regression analysis procedure (logit or Weibull) for each response variable. The NOEC
and LOEC will also be determined by comparison of treatment means using analysis of variance
(ANOVA) techniques. The mean for each concentration must then be compared with the control mean
using an appropriate multiple comparison or trend test method. Dunnett’s or Williams’ test may be useful.
It is necessary to assess whether the ANOVA assumption of homogeneity of variance holds. This
assessment may be performed graphically or by a formal test. Suitable tests are Levene’s or Bartlett’s.
Failure to meet the assumption of homogeneity of variances can sometimes be corrected by logarithmic
transformation of the data. If heterogeneity of variance is extreme and cannot be corrected by
transformation, analysis by methods such as step-down Jonkheere trend tests should be considered.
The excel macro sheet and R software will be used to analyse the results.
Results with reference substance (positive control):
The report will include at least the following information:
- Biomass measurements (shoot dry weight or fresh weight) of the plants as percentage of the controls
- Shoot height of the plants as percentage of the controls, if measured

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Remarks:
See attachment (Point 10.2.5) for further details.
Conclusions:
Even though the test needed for the update of the dossier before 29 September 2022 have been initiated, results are not available since the test are yet in progress