Registration Dossier
Registration Dossier
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EC number: 203-828-2 | CAS number: 111-05-7
Toxicity to terrestrial plants
Administrative data
- Endpoint:
- toxicity to terrestrial plants: short-term (with study design considered suitable for long-term assessment)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September - November 2016
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
- Version / remarks:
- In order to fulfil the ECHA recommendation regarding long term toxicity and determine the test item concentration range in which effects, on a reasonably broad selection of higher plants, are likely to occur, six plant species (two monocotyledonous plants and four dicotyledonous plants) were tested.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-hydroxypropyl)oleamide
- EC Number:
- 203-828-2
- EC Name:
- N-(2-hydroxypropyl)oleamide
- Cas Number:
- 111-05-7
- Molecular formula:
- C21H41NO2
- IUPAC Name:
- N-(2-hydroxypropyl)oleamide
- Test material form:
- other: waxy solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 160602013073 w/o Solvent
- Expiration date of the lot/batch: May 30th, 2018
- Purity test date: June 06th, 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:at room temperature ( between 15°c and 35°C)
- Stability under test conditions: stable
- Solubility in water: poorly soluble (in the range 0.02 to 0.75 mg/L)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: melted at 40°C
Sampling and analysis
- Analytical monitoring:
- no
Test substrate
- Vehicle:
- no
- Details on preparation and application of test substrate:
- The test item was not soluble in water, then it was melted at 40°C, following to the sponsor recommendations. The mass of melted test item, required to achieve test concentration, was incorporated into sand (50 g of sand for 2 000 g of soil dry mass). This preparation (test item + sand) was mechanically mixed, with the natural soil and partially moistened, with deionised water, to reach a preparation moisture around 10 %. After seeds sowing, the final moisture content was then adjusted by adding remaining required declorinated water by capillarity from the bottom of the pot.
Test organisms
open allclose all
- Species:
- Triticum aestivum
- Plant group:
- Monocotyledonae (monocots)
- Details on test organisms:
- - Common name: Wheat
- Plant family:Poaceae
- Variety:"Expert"
- Source of seeds: Bellois &Cie
- Batch :"récolte 2014"
- Species:
- Hordeum vulgare
- Plant group:
- Monocotyledonae (monocots)
- Details on test organisms:
- - Common name: Barley
-Plant family:Poaceae
- Variety:"Platine"
- Source of seeds: Bellois &Cie
- Batch :"récolte 2014"
- Species:
- Phaseolus vulgaris
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name:Garden Bean
- Plant family: Fabaceae
- Variety:" Fin de bagnols"
- Source of seeds: "Les doigts verts" company
- Batch : 18341Y
- Species:
- Brassica rapa
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Turnip
- Plant family: Brassicaceae
- Variety: "Rouge plat"
- Source of seeds: "Les doigts verts" company
- Batch : A29421X
- Species:
- Raphanus sativus
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Radish
- Plant family: Brassicaceae
- Variety: "18 jours"
- Source of seeds: "Les doigts verts" company
-Batch : H40542Y
- Species:
- Lepidum sativum
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Cress
- Plant family: Brassicaceae
- Variety:" Alenois"
- Source of seeds: "Les doigts verts" company
- Batch : A45451Z
Study design
- Test type:
- seedling emergence and seedling growth test
- Study type:
- laboratory study
- Substrate type:
- natural soil
- Remarks:
- LUFA 2.3
- Limit test:
- no
- Total exposure duration:
- 19 d
- Remarks:
- 18 days for monocotyledonae and 19 days for dicotyledonae
- Post exposure observation period:
- No
Test conditions
- Test temperature:
- Light period : 24 +/- 3°C
Dark period : 20 +/- 3°C
See table 2 for detailed informations - pH:
- Natural soil pH : 7.2 (KCl)
See table 5 for detailed values at the beginning and at the end of the study - Moisture:
- Natural soil moisture content : 5.2%
- Details on test conditions:
- TEST SYSTEM
- Testing facility: Climatic chambers
- Test container (type, material, size): Plastic plant pot 85 mm diameter - 110 mm height
- Amount of soil: approx 330 g (dry mass) of soil or test mixture
- No. of seeds per container: see table 1
- No. of plants (retained after thinning): no thinning
- No. of replicates per treatment group: see table 1
- No. of replicates per control: see table 1
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Germany (Landwirtshaftliche Untersuchungs und Forschunsanstalt)
- Pesticide use history at the collection site: no application of pesticides, biocidal fertilizers or organic manure for at least 5 years
- Collection procedures:
- Sampling depth (cm): 0-20 cm depth
- Particle size distribution: (%) (according to supplier informations)
<0.002: 6,8 +- 1,6
0.002 - 0.05 : 33,6 +- 0,5
0.05 - 2.0: 59,6 +- 1,4
- Soil taxonomic classification: sandy loam
- Soil classification system: USDA
- CEC (meq/100g): 7.6+/- 0.8
Characteristics measured in Laboratory
- Organic carbon (%): 0.66
- Water holding capacity : 22.3%
Pretreatment of soil (immediatly after sampling)
- Dried 1 day at room temperature
- Sieved at 2 mm
Storage:
- 1 month in open bags allowing gas exchange, at room temperature
GROWTH CONDITIONS
- Photoperiod: 16h light / 8h night
- Light source: horticol light
- Light intensity : 6020 to 10 000 Lux see details in table 2
- Day/night temperatures: see details in table 2
- Relative humidity (%): see details in table 2
- Watering regime and schedules: Soil moisture was maintained constant around 70 % of soil water holding capacity by weighting pots and replenishing with dechlorinated tap water at least 3 times a week
-Method of application : Replenish by the bottom of the pot
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Number of emerged seedlings
- Final biomass (plant dry mass)
- Visible detrimental effects on the plants
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.4
- Range finding study
- Test concentrations: 1 - 10- 100 - 1000 mg/kg soil dw
- Exposure : 14 days
- Results used to determine the conditions for the definitive study: see table 4 - Nominal and measured concentrations:
- Following nominal test concentrations were selected according to the range finding results:
260.3 - 364.4 - 510.2 - 714.3 and 1 000 mg /kg soil dw
Prepared test concentrations were slightly different for each species (see table 4). Indeed it was difficult to obtain the exact required weight of melted test item due to its viscosity - Reference substance (positive control):
- yes
- Remarks:
- Sensitivity of the test species batch was checked using boric acid .
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Species:
- Triticum aestivum
- Duration:
- 18 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- seedling emergence
- Remarks on result:
- other: Highest tested concentration
- Key result
- Species:
- Triticum aestivum
- Duration:
- 18 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks on result:
- other:
- Remarks:
- Highest tested concentration
- Key result
- Species:
- Hordeum vulgare
- Duration:
- 18 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- seedling emergence
- Remarks on result:
- other:
- Remarks:
- Highest tested concentration
- Key result
- Species:
- Hordeum vulgare
- Duration:
- 18 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks on result:
- other:
- Remarks:
- Highest tested concentration
- Key result
- Species:
- Phaseolus vulgaris
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- seedling emergence
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Phaseolus vulgaris
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Brassica rapa
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- seedling emergence
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Brassica rapa
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Lepidum sativum
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- germination
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Lepidum sativum
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Raphanus sativus
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- seedling emergence
- Remarks on result:
- other:
- Remarks:
- highest tested concentration
- Key result
- Species:
- Raphanus sativus
- Duration:
- 19 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 364.4 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Key result
- Species:
- Raphanus sativus
- Duration:
- 19 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 510.1 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- growth
- Details on results:
- SEEDLING EMERGENCE
Percent seedling emergence: see detailed results in table 6
For the six species, satisfactory emergence rate were measured in control conditions at the end of the test ( 72.2 - 97.2%) and no statistical effect was observed on seedling emergence.
VISUAL SLEEDLING OBSERVATION:
For the six species, no phytotoxic effect was observed in control conditions and in all test concentrations.
DRY BIOMASS MEASURMENTS : see detailed results in table 7
Statistical differences, compared to the control, were observed :
- wheat (hormesis effect when considering biomass per plant) at 363.9 and 510.1 mg/kg (soil dry mass);
- turnip and cress (hormesis effect) at 510.1, 714.4 and 1 000 mg/kg (soil dry mass);
- radish (growth inhibition), at 510.1, 714.1 and 1 000 mg/kg (soil dry mass). - Results with reference substance (positive control):
- - Results with reference substance valid? YES
- Relevant effect levels:
EC50 (and confidence limits at 95%) of Boric Acid were determined for each species, based on dry biomass measurement :
Wheat : 501.9 mg/kg soil dw (469.0 - 533.4)
Barley: 654.6 mg/kg soil dw (594.0 - 708.9)
Garden Bean: 276.9 mg/kg soil dw (225.9 - 325.3)
Turnip: 300.7 mg/kg soil dw (266.9 - 325.3)
Cress: 398.4 mg/kg soil dw (301.3 - 588.1)
Radish: 430.0 mg/kg soil dw (389.5 - 473.1)
EC50 values obtained were in accordance with the toxicity ranges given in the ISO 11269-2 standard
- Reported statistics and error estimates:
- Statistics were performed using Toxstat 3.5, Western Inc. and D. Gulley, University of Wyoming.
Normality and homogeneity of the data were verified and the significativity of the effect on growth was considered, by performing a one-way ANOVA (α-value = 0.05) followed by the Dunett’s post-hoc t-test (α-value = 0.05)
Any other information on results incl. tables
Table 6: Seedling emergence at day 4 and at the end of the exposure
Test concentration concentration |
Seedling emergence in % |
||||||
Observation day |
Control |
260.3 |
364.4 |
510.2 |
714.3 |
1 000 |
|
Wheat (36 seeds) |
4 |
94.4 |
91.7 |
86.1 |
83.3 |
88.9 |
86.1 |
18 |
97.2 |
97.2 |
88.9 |
88.9 |
94.4 |
97.2 |
|
Emergence inhibition rate (%) |
18 |
/ |
0 |
8.6 |
8.6 |
2.9 |
0 |
Barley (36 seeds) |
4 |
97.2 |
94.4 |
100 |
100 |
97.2 |
94.4 |
18 |
97.2 |
94.4 |
100 |
100 |
97.2 |
94.4 |
|
Emergence inhibition rate (%) |
18 |
/ |
2.9 |
-2.9 |
-2.9 |
0 |
2.9 |
Garden bean (32 seeds) |
4 |
65.6 |
62.5 |
59.4 |
56.3 |
59.4 |
43.8 |
19 |
93.8 |
90.6 |
96.9 |
93.8 |
84.4 |
90.6 |
|
Emergence inhibition rate (%) |
19 |
/ |
3.3 |
-3.3 |
0 |
10 |
3.3 |
Turnip (36 seeds) |
4 |
94.4 |
88.9 |
91.7 |
100 |
91.7 |
86.1 |
19 |
94.4 |
94.4 |
97.2 |
100 |
94.4 |
91.7 |
|
Emergence inhibition rate (%) |
19 |
/ |
0 |
- 2.9 |
- 5.9 |
0 |
2.9 |
Cress (36 seeds) |
4 |
61.1 |
75.0 |
61.1 |
69.4 |
66.7 |
75.0 |
19 |
72.2 |
80.6 |
80.6 |
80.6 |
77.8 |
83.3 |
|
Emergence inhibition rate (%) |
19 |
/ |
- 11.5 |
- 11.5 |
- 11.5 |
- 7.9 |
- 15.4 |
Radish (36 seeds) |
4 |
94.4 |
88.9 |
91.7 |
100 |
97.2 |
94.4 |
19 |
94.4 |
91.7 |
94.4 |
100 |
97.2 |
94.4 |
|
Emergence inhibition rate (%) |
19 |
/ |
2.9 |
0 |
-5.9 |
-2.9 |
0 |
Table 7: Mean biomass (dry mass) of seedlings and growth inhibition calculation
|
Mean biomass (mg) per |
Growth inhibition (%) per |
||||
|
Test concentration |
Number of harvested plants |
replicate |
plant |
replicate |
plant |
Wheat |
Controls |
35 |
198.9 |
34.0 |
/ |
/ |
262.1 |
35 |
227.1 |
38.8 |
-14.2 |
-14.1 |
|
363.9 |
32 |
229.8 |
43.8 |
-15.6 |
-28.5 |
|
510.1 |
31a |
206.2 |
40.0 |
-3.7 |
-17.6 |
|
714.4 |
34 |
224.1 |
39.6 |
-12.7 |
-16.4 |
|
1 000 |
35 |
217.5 |
37.2 |
-9.4 |
-9.4 |
|
Barley |
Controls |
35 |
289.5 |
49.8 |
/ |
/ |
262.1 |
34 |
279.5 |
49.7 |
3.4 |
0.3 |
|
363.9 |
36 |
323.2 |
53.9 |
-11.7 |
-8.2 |
|
510.1 |
36 |
318.9 |
53.2 |
-10.2 |
-6.7 |
|
714.4 |
35 |
276.7 |
47.6 |
4.4 |
4.5 |
|
1 000 |
34 |
291.7 |
51.8 |
-0.8 |
-3.9 |
|
Garden bean |
Controls |
30 |
1176.4 |
315.9 |
/ |
/ |
260.2 |
27a |
1149.0 |
347.2 |
2.3 |
-9.9 |
|
367.4 |
27a |
1025.9 |
288.5 |
12.8 |
8.7 |
|
510.2 |
30 |
1067.5 |
295.3 |
9.2 |
6.5 |
|
714.4 |
24a |
925.5 |
307.3 |
21.3 |
2.7 |
|
1 000 |
27a |
1069.5 |
321.3 |
9.0 |
-1.7 |
|
Turnip |
Controls |
34 |
154.7 |
27.5 |
/ |
/ |
260.9 |
33a |
112.6 |
20.7 |
27.2 |
24.8 |
|
364.4 |
33a |
150.7 |
27.7 |
2.6 |
-0.7 |
|
510.1 |
35a |
229.2 |
39.2 |
-48.2 |
-42.7 |
|
714.4 |
34 |
205.0 |
36.0 |
-32.5 |
-31.0 |
|
1 000 |
33 |
186.1 |
33.9 |
-20.3 |
-23.1 |
|
Cress |
Controls |
26 |
57.6 |
14.1 |
/ |
/ |
260.9 |
29 |
79.8 |
16.8 |
-38.5 |
-18.9 |
|
364.4 |
28a |
75.3 |
16.2 |
-30.7 |
-14.8 |
|
510.1 |
28a |
107.6 |
24.1 |
-86.8 |
-71.2 |
|
714.4 |
26a |
95.1 |
23.1 |
-65.0 |
-63.5 |
|
1 000 |
30 |
90.9 |
18.3 |
-57.8 |
-29.6 |
|
Radish |
Controls |
34 |
327.2 |
58.0 |
/ |
/ |
260.3 |
32a |
315.5 |
59.8 |
3.6 |
-3.2 |
|
364.4 |
34 |
305.6 |
54.2 |
6.6 |
6.6 |
|
510.1 |
36 |
284.7 |
47.5 |
13.0 |
18.1 |
|
714.1 |
35 |
260.3 |
44.8 |
20.4 |
22.8 |
|
1 000 |
33a |
232.3 |
43.3 |
29.0 |
25.4 |
|
a: number of harvested plants different from number of emerged seeds due to no development or necrosis (see table 6)
Negative values correspond to a higher growth in test concentration than in control conditions.
Table 8: Minimal significant difference values calculated during statistical analysis
Minimal significant difference (in % of control) |
Wheat |
Barley |
Garden bean |
Turnip |
Cress |
Radish |
Per replicate |
18.5 |
13.3 |
27.1 |
34.4 |
42.9 |
12.1 |
Per plant |
16.8 |
14.1 |
23.2 |
28.3 |
38.8 |
15.7 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For the six species, in control conditions: Seedling emergence was higher than 70%, No phytotoxic effect was observed;Mean survival of emerged seedlings was higher than 90% (100%).
- Executive summary:
In order to assess the effect of the test item “N-(2-hydroxypropyl) Oleamide” on emergence and early growth of the plants, the study was performed on six higher plants species (4 dicotyledonous species and 2 monocotyledonous species).
For the six tested species, no effect was observed on seedling emergence at any concentration.
For seedling growth, statistically significant effects were observed for:
- wheat (hormesis effect per plant) at 363.9 and 510.1 mg/kg (soil dry mass);
- turnip and cress (hormesis effect) at 510.1, 714.4 and 1 000 mg/kg (soil dry mass);
- radish (growth inhibition), at 510.1, 714.1 and 1 000 mg/kg (soil dry mass).
According to these results, no NOEC can be determined for five of the six species, NOEC value was ≥ 1000 mg/kg soil dry mass (highest tested concentration).
For radish a NOEC at 364.4 mg/kg soil dry mass and a LOEC at 510.1 mg/kg soil dry mass were determined
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