Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Toxicity to terrestrial plants

Currently viewing:

Administrative data

Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.03.2022 - 11.08.2022
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022
Report date:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants, Growth Test)
Version / remarks:
2006
Deviations:
yes
Remarks:
no impact on study (see Overall remarks, attachments)
GLP compliance:
yes

Test material

1
Reference substance name:
SDA Product (desulphurization of exhaust gases by semi-dry absorption method from the coal fired power plants)
EC Number:
931-259-6
Molecular formula:
Not available
IUPAC Name:
SDA Product (desulphurization of exhaust gases by semi-dry absorption method from the coal fired power plants)
Test material form:
solid: bulk
Details on test material:
Boundary composition of the test material to cover all member of JS. The analysis of the test material will be performed prior the testing and the exact composition of the test material will be included in study reports:
Calcium sulfate (CAS 7778-18-9) 1-79%
Calcium sulfite hemihydrate (CAS 29501-28-8) 1-75%
Calcium carbonate (CAS 471-34-1) 1-45%
Calcium dihydroxide (CAS 1305-62-0) 0-35%
Calcium dichloride dihydrate (CAS 10035-04-8) 0-35%
Calcium difluoride (CAS 7789-75-5) 0-5%



Sampling and analysis

Analytical monitoring:
no
Remarks:
One test product will be provided together with a Certificate of Analysis. Samples of soils with the lowest and the highest concentration of the test item used in the definitive test will be taken and stored in a freezer for a minimum period of two years.

Test substrate

Vehicle:
yes
Remarks:
tap water
Details on preparation and application of test substrate:
- Method of mixing into soil (if used):

Artificial soils were prepared according to calculation sheets - see Overall remarks, attachments.
Ingredients:
• Sand: Kinderspielsand, Bauhaus, 0-2mm dried under room temperature and humidity on tarp
• Gardening substrate: Propagation substrate Suliflor SF1 (>80% organic matter, NPK 14-16-18). Dried at 105°C
• Test product
• Tap water
.
The soils were prepared separately for each treatment by mixing 3 % of dried gardening substrate (>80 % organic matter), 0–8.1 % test product and 97–88.9 % dry sand (0–2mm) and moistenning the content with tap water (20 % of the dry soil weight). The soil was then filled into pots (approximatelly 0.52–0.54 kg dry soil per pot) before planting the seeds.
For details of the pH and conductivity of the final soils - see Overall remarks, attachments.




- Method of application to soil surface (if used):
Test soil
Seeds will be planted in a sandy loam, loamy sand, or sandy clay loam that contain up to 1.5 % organic carbon (approx. 3 % organic matter). Commercial potting soil or synthetic soil mix that contains up to 1.5 % organic carbon will be used. The type and texture, % organic carbon, pH and salt content as electronic conductivity of the prepared soil will be reported.


- Controls: an untreated soil used as a control

- Chemical name of vehicle: water

- Concentration of vehicle in test medium (stock solution and final test solution): 2800 g tap water

Test organisms

open allclose all
Species:
Avena sativa
Species:
Brassica napus
Species:
other: Solanum lycopersicum
Details on test organisms:
Tomato
Species:
Zea mays
Species:
Helianthus annuus
Species:
Glycine max (G. soja)

Study design

Test type:
seedling emergence and seedling growth test
Study type:
laboratory study
Substrate type:
artificial soil
Remarks:
Dry artificial soil consist of dry sand and 3% dry gardening substrate (>80 % organic matter)
Total exposure duration:
21 d
Post exposure observation period:
Final assessment was conducted between 14 and 21 days after 50% emergence of the particular plant in untreated control soil (21 or 22 days after test initiation).

Test conditions

Test temperature:
22 °C ± 10°C
pH:
see table in section Overall remarks...
Moisture:
Water content at the soil - start: 20 % of the dry soil weight
Details on test conditions:
TEST SYSTEM
- Testing facility: The plants was kept in glasshouse. The plants was maintained under good horticultural practices.
- Test container (type, material, size): 10x10 cm pots filled with soil
- Amount of soil: approximatelly 0.52–0.54 kg dry soil per pot

- Method of seeding: seeds will be planted into 10 cm×10 cm pots filled with soil at seed density at least 4 seeds per pot for oat and oilseed rape and at least 2 seeds per pot for tomato, corn, sunflower and soybean will be used

- No. of seeds per container: Minimum number of seeds for each treatment and control group will be 20.
- No. of replicates per treatment group: In the definitive test, at least five replicates (pots) for oat, tomato and oilseed rape and ten replicates (pots) for corn, sunflower and soybean will be used for each of five test item rates and for untreated control.


SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): Commercial potting soil or synthetic soil mix that contains up to 1.5 % organic carbon was used. The type and texture, % organic carbon, pH and salt content as electronic conductivity of the prepared soil will be reported (see Overall remarks...)
- Organic carbon (%): up to 1.5 %
- Maximum water holding capacity (in % dry weigth): moistenning the content with tap water (20 % of the dry soil weight)
- Pretreatment of soil: Sand 0-2mm dried under room temperature and humidity on tarp; Gardening substrate dryied at 105°C

NUTRIENT MEDIUM (if used)
Nutrients for plant growth will be provided to ensure that plants are not stressed through nutrient deficiencies.

GROWTH CONDITIONS
Test was conducted under conditions suitable for normal growth of the species and varieties tested. Conditions recommended by OECD 208 (2006) guideline are the following:
- Day/night temperatures: 22 °C ± 10°C
- Relative humidity (%): 70 % ± 25 %
- Photoperiod: minimum 16h light
- Light intensity and quality: 350±50 μE/m2/s
- Light source: natural daylight; To avoid biass that might be caused e.g. by unequal lighting, pots belonging to individual treatments were either reorganised
periodically (range-finding test) or distributed in a way removing effects of any potential gradient (definitive test)
- Air exchange rate: by air conditioning system

- Water source/type: tap water
- Volume applied: whenever necessary (every 1–3 days)
- Interval of applications: every 1-3 days
- Method of application: bottom watering (however, initial top watering can be conducted to stimulate seed germination and facilitate movement of the chemical into the soil)

- Any fertilization (if used): yes
Product name: Kristalon Start NPK 19-6-20 + 3Mg0 + 7.5SO3 + ME (manufacturer: AGRO CS a.s., Říkov)
Application: 10g/10l watering water. Applied once per week (approximately 75mL per pot)
Application dates: Range finding test: D14, D120; Definitive test: D6, D14, D20

ACCLIMATION PERIOD: no

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Phytotoxicity At least once a week following 50% emergence in controls (chlorosis, necrosis, discoloration, plant growth abnormalities etc.)
Shoot length End of the trial (Shoot length of each survived plant)
Plant biomass End of trial (Dry weight per pot )

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: <3

- Range finding study
The range-finding test was conducted with five rates spaced by a factor 10, with the highest rate 10 g product /kg dry soil (10, 1, 0.1, 0.01, 0.001 g/kg dry soil).
Untreated control was included. The test product was mixed with soil.

- Test concentrations
The test product was be applied at five rates, based on the results of a range-finding test, spaced by a factor <3.
1, 3, 9, 27, 81 g/kg dry soil ( Oat, Corn, Soy bean)
0.333, 1, 3, 9, 27 g/kg dry soil (Sunflower, Tomato, Oilseed rape)

- Results used to determine the conditions for the definitive study:
There were no treatment-dependent differences in emergence and survival in any plant species. Decreased shoot length and/or dry shoot weight was detected in all plant species in one or two highest product concentrations. Test concentrations to be included in the definitive test were therefore moved towards higher concentrations in order to cover ideally 20–80% detrimental effects
Nominal and measured concentrations:
Nominal concentrations
1, 3, 9, 27, 81 g/kg dry soil ( Oat, Corn, Soy bean)
0.333, 1, 3, 9, 27 g/kg dry soil (Sunflower, Tomato, Oilseed rape)

Results and discussion

Effect concentrationsopen allclose all
Species:
Avena sativa
Duration:
22 d
Dose descriptor:
EC50
Effect conc.:
50.38 g/kg soil dw
95% CI:
> 32.71 - < 76.35
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Species:
Avena sativa
Duration:
22 d
Dose descriptor:
NOEC
Effect conc.:
3 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
Avena sativa
Duration:
22 d
Dose descriptor:
EC50
Effect conc.:
12.69 g/kg soil dw
95% CI:
> 8.28 - < 19.51
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Avena sativa
Duration:
22 d
Dose descriptor:
NOEC
Effect conc.:
1 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Helianthus annuus
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
29.9 g/kg soil dw
95% CI:
> 12.71 - < 67.64
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
Helianthus annuus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.33 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Length
Species:
Helianthus annuus
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
10.25 g/kg soil dw
95% CI:
> 4.7 - < 22
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Helianthus annuus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Zea mays
Duration:
22 d
Dose descriptor:
EC50
Effect conc.:
69.26 g/kg soil dw
95% CI:
> 34.89 - < 133.08
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
Zea mays
Duration:
22 d
Dose descriptor:
NOEC
Effect conc.:
1 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
Zea mays
Duration:
22 d
Dose descriptor:
EC50
Effect conc.:
7.88 g/kg soil dw
95% CI:
> 1.55 - < 40.44
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Zea mays
Duration:
22 d
Dose descriptor:
NOEC
Effect conc.:
3 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
17.2 g/kg soil dw
95% CI:
> 12 - < 24.53
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Length
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
7.19 g/kg soil dw
95% CI:
> 2.96 - < 17.24
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Brassica napus
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
other: Tomato (Solanum lycopersicum)
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
8.43 g/kg soil dw
95% CI:
> 5.86 - < 12.05
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
other: Tomato (Solanum lycopersicum)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Length
Species:
other: Tomato (Solanum lycopersicum)
Duration:
22 d
Dose descriptor:
EC50
Effect conc.:
3.85 g/kg soil dw
95% CI:
> 2.5 - < 5.86
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
other: Tomato (Solanum lycopersicum)
Duration:
22 d
Dose descriptor:
NOEC
Effect conc.:
1 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
76.55 g/kg soil dw
95% CI:
> 45.69 - < 124.96
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: shoot lenght
Remarks:
Shoot Length
Species:
Glycine max (G. soja)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
27 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Length
Species:
Glycine max (G. soja)
Duration:
22 d
Dose descriptor:
EC50
Effect conc.:
34.96 g/kg soil dw
95% CI:
> 15.31 - < 77.79
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Species:
Glycine max (G. soja)
Duration:
22 d
Dose descriptor:
NOEC
Effect conc.:
1 g/kg soil dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Shoot Dry Weight
Reported statistics and error estimates:
Statistical analyses of the data were performed using ToxRat 3.2. statistical software. There were no substantial and treatment-dependent differences is seedling emergence and survival. These endpoints were thus excluded from statistical analysis. EC10 EC25 and EC50 for shoot length and dry shoot weight were calculated by fitting the data with the 3-parametric normal cumulative distribution function which was followed by Analysis of variance and Test for lack of fit. NOEC was determined by Williams multiple sequential t-test procedure, Step-down Jonckheere-terpstra test procedure, Multiple Sequentially-rejective Median (2x2-Table) Test After Bonferroni-Holm or Multiple Sequentially-rejective Welsh-t-test After Bonferroni-Holm. The most appropriate method was selected on the basis of results of Shapiro-Wilk’s test (testing normality of distribution), Levene’s test (testing homogeneity of variances) and Trend analysis by Contrasts (testing monotonicity of concentration/response). Datailed statictical outputs are in Appendix VII of study report.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
• emergence >70%; • seedlings do not exhibit visible phytotoxic effects; plants exhibit normal variation in growth and morphology for that particular species • mean survival of emerged control seedlings >90% • environmental conditions identical
Conclusions:
Selected plant species exposed to the test product mixed in artificial soil exhibited EC10 (in terms of dry shoot weight as the main endpoint) within the range 0.36–5.45 g product/kg dry soil, and EC50 within the range 3.85–34.96 g product/kg dry soil.
Executive summary:

A GLP glasshouse trial was conducted to evaluate the effects of a UVCB substance on seedling emergence and early growth of six representative plant species following exposure to the test item. The study was conducted in accordance with the OECD Guideline (208, 2003: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test).


                Seeds of six plants (oat, oilseed rape, tomato, corn, sunflower and soybean) were planted into pots filled with artificial soils containing 5 diferent concentrations of the test item and an untreated soil used as a control. The test item concentrations were selected on the basis of a range-finding test conducted beforehand. Seedlings were observed for 2 weeks after 50% emergence detected in the control and marks of phytotoxicity were recorded. Final assessment conducted 3 weeks after test initiation included determination of mean shoot length and mean dry weight per plant in each treatment as the main endpoints.


                No effect of the test item on the seedling emergence and survival was detected in all plant. Effective concentrations causing 10, 25 and 50% reduction of final shoot height and dry weight (EC10, EC25 and EC50) and No Observed Effect Concentrations (NOEC) are summarised below:
























































































Endpoint



Shoot length



Dry shoot weight



Effective concentration



EC10


(g/kg)



EC25


(g/kg)



EC50


(g/kg)



NOEC


(g/kg)



EC10


(g/kg)



EC25


(g/kg)



EC50


(g/kg)



NOEC


(g/kg)



Oat



5.97



16.40



50.38



3.0



2.13



4.97



12.69



1.0



Sunflower



4.12



10.54



29.90



0.33



2.78



5.15



10.25



3.0



Corn



5.75



18.69



69.26



1.0



0.36



1.55



7.88



3.0



Tomato



2.50



4.45



8.43



3.0



1.57



2.40



3.85



1.0



Oilseed rape



5.02



8.99



17.20



3.0



1.79



3.46



7.19



1.0



Soybean



21.30



39.04



76.55



27.0



5.45



13.14



34.96



<1.0