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Toxicity to terrestrial plants

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Reference
Endpoint:
toxicity to terrestrial plants: long-term
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The selection of the test system was based on:
 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L 136/3.
 Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union L 142/1.
 Commission Regulation (EU) No 640/2012 of 6 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Official Journal of the European Union L193/1.
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
Version / remarks:
2006
Deviations:
yes
Remarks:
Air humidity was below 30 % most of the time for the species Brassica napus, but without adverse effect induced by dehydration. This deviation had no impact on the conduct or integrity of the study.
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch: April 2017
- Purity test date: /

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: /
- Solubility and stability of the test substance in the solvent/vehicle: /
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: /

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)
/

OTHER SPECIFICS
/
Analytical monitoring:
no
Vehicle:
yes
Remarks:
Acetone was used to dilute item, but evaporated before inclusion of the coated quartz into the soil.
Species:
Allium cepa
Plant group:
Monocotyledonae (monocots)
Species:
Avena sativa
Plant group:
Monocotyledonae (monocots)
Species:
Brassica napus
Plant group:
Dicotyledonae (dicots)
Species:
Cucumis sativus
Plant group:
Dicotyledonae (dicots)
Species:
Pisum sativum
Plant group:
Dicotyledonae (dicots)
Species:
Lycopersicon esculentum
Plant group:
Dicotyledonae (dicots)
Test type:
seedling emergence and seedling growth test
Study type:
laboratory study
Substrate type:
natural soil
Limit test:
no
Total exposure duration:
14 d
Remarks:
Seeds were left to grow for 14 (A. cepa, A. sativa, C. sativus), 15 (P. sativum, S. lycopersicum) or 16 days (B. napus) following 50 % emergence of the control plants.
Test temperature:
A. cepa: 14.2 to 23.6°C
A. sativa and C. sativus: 14.2 to 23.6
P. sativum and S. lycopersicum: 14.2 to 23.6
B. napus: 21.3 to 26.2
pH:
Not provided
Moisture:
A. cepa: 30.4 to 48.9%
A. sativa and C. sativus: 31.4 to 48.9
P. sativum and S. lycopersicum: 31.4 to 48.9
B. napus: 14.8 to 35.2
Details on test conditions:
TEST SYSTEM
- Testing facility: ECT Oekotoxikologie GmbH, Flörsheim am Main, Germany
- Test container (type, material, size): Common plant pots made of polypropylene (diameter 11 cm, height 8.5 cm)
- Amount of soil: 480 ± 5 g
- Method of seeding: The seeds were picked with a pair of tweezers and pressed into the soil at a uniform distance between seeds.
- No. of seeds per container: 6
- No. of plants (retained after thinning): 6 for A cepa and A sativa, 3 for the other species (B napus, C. sativus, P sativum, S lycopersicum)
- No. of replicates per treatment group: 4 or A cepa and A sativa, 7 for other species (B napus, C. sativus, P sativum, S lycopersicum)
- No. of replicates per control: Same as concentrations
- No. of replicates per vehicle control: Same as concentrations

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: LUFA soil Type Sp 5M was collected from an uncultivated field at Mechtersheim, Rhineland-Palatinate, Germany
- Pesticide use history at the collection site: The field had neither received any organic fertilisers nor plant protection substances during the last four years before sampling
- Collection procedures: /
- Sampling depth (cm): /
- Soil texture (if natural soil): <=2 mm
- % sand: 59.3 ± 1.5
- % silt: 30.1 ± 1.4
- % clay: 10.6 ± 0.8
- Soil taxonomic classification: sandy loam
- Soil classification system: USDA
- Composition (if artificial substrate): Not relevant
- Organic carbon (%): 1.02 ± 0.08
- Maximum water holding capacity (in % dry weigth): 40.1 ± 2.4
- CEC [meq/100 g]: 17.7 ± 3.7
- Pretreatment of soil: None
- Storage (condition, duration): Stored at ambiant temperature

NUTRIENT MEDIUM (if used)
- Description: water reservoirs were filled with deionised water, and a nutrient solution (“Substral®”, 6 ml/L H2O) was added as needed.

GROWTH CONDITIONS
- Photoperiod: 16hours
- Light source: artificial lighting (SON-T-Agro high pressure metal halide lamps)
- Light intensity and quality: 201 to 268 µE m-2 s-1 for B. napus, and 213 to 352 µE m-2 s-1 for the other species
- Day/night temperatures: 21.3 to 26.2°C or B. napus, and 14,2 to 23.6°C for the other species
- Relative humidity (%): 37.9% (30.4-48.9) for A. cepa, 38.6% (31.4-48.9) for A. sativa and C. sativus, 38.4% (31.4-48.9) for P. sativum and S. lycopersicum, 21.8% (14.8-35.2) for B. napus
- Wind velocity: Not relevant
- Air exchange rate: not reported
- Watering regime and schedules: water reservoirs were filled with deionised water
- Water source/type: deionised water, source not reported
- Volume applied: water was added to the reservoirs as necessary to maintain the soil sufficiently moist
- Interval of applications: ditto
- Method of application: ditto
- Any pest control method/fertilization (if used): No

ACCLIMATION PERIOD: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : no

- Phytotoxicity rating system (if used): yes (! healthy, 2 slightly damaged with chlorotic or necrotic leaves, 3 slightly damaged with single wilted leaves, 4 severely damaged more than 1/4 of the plant, 5 severely damaged with developmental abnormalities, and 6 dead

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5
- Justification for using less concentrations than requested by guideline: /
- Range finding study
- Test concentrations: 0 (control & solvent control), 198, 296, 444, 667, 1000 mg/ kg soil dw
- Results used to determine the conditions for the definitive study: No
Nominal and measured concentrations:
Nominal concentrations
Control / Solvent control / 198 / 296 / 444 / 667 / 1000 mg/kg soil dw
Reference substance (positive control):
no
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
ca. 444 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
ca. 667 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
EC10
Effect conc.:
228.2 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Allium cepa
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
906.6 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
296 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
444 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Brassica napus
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Brassica napus
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Brassica napus
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Brassica napus
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Brassica napus
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
667 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Brassica napus
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Cucumis sativus
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Cucumis sativus
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Cucumis sativus
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Cucumis sativus
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Cucumis sativus
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
667 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Cucumis sativus
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Pisum sativum
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Pisum sativum
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Pisum sativum
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Pisum sativum
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Pisum sativum
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Pisum sativum
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
< 198 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
198 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Key result
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
EC10
Effect conc.:
176.9 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Key result
Species:
Lycopersicon esculentum
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
707.1 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
Measure: shoot fresh weight
Details on results:
Mean shoot fresh weight [g] at the end of the test.
Treatment code C SC T1 T2 T3 T4 T5
Test item
[mg/kg soil dw] 0.0 0.0 198 296 444 667 1000
A. cepa 0.221 0.236 0.200 0.217 0.178 0.131* 0.116*
A. sativa 1.095 1.157 1.045(*) 1.050 1.015* 0.827* 0.881*
B. napus 2.159 2.126 1.682* 2.099 1.993 1.942 1.601*
C. sativus 3.326 3.177 2.834 2.884 2.850 2.827 2.356*
P. sativum 2.450 2.507 2.501 2.543 2.790 2.282 2.332
S. lycopersicum 1.945 1.711 1.481* 1.372* 1.251* 0.695* 0.739*
C = control; SC = solvent control; T1 to T5 = test item treated; * significantly different from solvent control (p=0.05, one sided smaller); (*) = significantly different; however, considered not to be relevant (not dose related).
Reported statistics and error estimates:
Emergence and survival data were checked by the Fisher's exact binominal test with Bonferroni correction to determine the NOEC and LOEC. Significance level was alpha = 0.05, one sided greater .
Probit Analysis was used to determine the effective concentrations EC10, EC20 and EC50.
Normal distribution and homogeneity of variances were checked by the Kolmogorov-Smirnov Test and Cochran’s test, respectively.
NOEC and LOEC of shoot fresh weight were determined by applying either the Williams multiple sequential t-test (monotonous dose-response relationship) or Dunnett’s Multiple t-Test (non-monotonous dose response relationship). In case of inhomogeneous variances Welch t-Test was applied. Significance level was alpha = 0.05, one-sided smaller.
Statistical evaluations were performed using the ToxRat Pro software Version 2.10 (ToxRat Solutions GmbH, 2010).
Validity criteria fulfilled:
yes
Remarks:
The deviation regarding the low humidity does not impact the study results; this is notably supported by the results on controls.
Conclusions:
The effect of the test item Rape Oil, oxidized, on the emergence and growth of six species of higher terrestrial plants was tested under laboratory conditions.

Under the conditions tested, the test item had no statistically significant adverse effect on seedling emergence and seedling survival in any of the six tested plant species at any of the tested test item concentrations up to and including 1000 mg/kg soil dry weight. NOECs for emergence and survival were therefore all >= 1000 mg/kg soil dw.

The Test item reduced the shoot fresh weight in five of the six species. The lowest NOEC and EC10 were observed with the test species Solanum lycopersicum ≤198 mg/kg soil dry weight and 176.9 mg/kg soil dry weight, respectively.
Executive summary:

The study was conducted according to OECDTG208 and under GLP in order to determine possible effects of the test item on the seedling emergence and early growth of higher terrestrial plants. Therefore, seeds of six different test species representing six plant families were planted in soil treated with test item at various concentrations.

The test item was dissolved in acetone and applied to quartz sand. After complete evaporation of the acetone the spiked sand was mixed into the test soil. Control plants were grown in soil mixed with sand that was treated with acetone but without the test item (solvent control) and also in soil amended with sand that was neither treated with solvent nor with test item (control). Emergence rate, survival of seedlings, shoot fresh weight, and visual detrimental effects (chlorosis, necrosis, development abnormalities) were assessed. Visual detrimental effects, emergence rate and survival of seedlings were assessed on day 7 and at the end of the test, i.e. earliest on day 14, latest on day 21. Shoot fresh weight was evaluated only at the end of the test.

Under the conditions tested, the test item had no statistically significant adverse effect on seedling emergence and seedling survival in any of the six tested plant species at any of the tested test item concentrations up to and including 1000 mg/kg soil dry weight.

The test item reduced the shoot fresh weight in five of the six species. The lowest NOEC and EC10 were ≤198 mg/kg soil dry weight and 176.9 mg/kg soil dry weight, respectively, and were observed with the test species Solanum lycopersicum.

Description of key information

A toxicity study on six plant species was performed according to OECD TG208 and in compliance with GLP.

Out of the 6 test species, seed emergence and survival were not affected. In consequence NOECs and LOECs were stated at the maximum tested concentration, >= 1000 and >1000 mg/kg soil dw, respectively.

Shoot weight was affected in five test species, with for S. lycopersicum (Lycopersicon esculentum) the lowest NOEC and LOEC <198 and =198 mg/kg soil dw, respectively. The lowest EC10 and EC50 were for S. lycopersicum, 176.9 and 707.1 mg/kg dw, respectively.

Key value for chemical safety assessment

Short-term EC50 or LC50 for terrestrial plants:
707.1 mg/kg soil dw
Long-term EC10, LC10 or NOEC for terrestrial plants:
176.9 mg/kg soil dw

Additional information

The emergence and growth of six test species (two monocotyledons, Avena sativa (oats) and Allium cepa (onion)) and four dicotyledons (Brassica napus (oilseed rape), Cucumis sativus (cucumber), Pisum sativum (peas) and Solanum lycopersicum (tomato)) in a natural sandy loam soil was followed for 14 to 16 days while exposed to 198, 296, 444, 667 and 1000 mg test item/kg soil dry weight.

Seedling emergence in test item treated soil did not differ significantly from seedling emergence in the solvent control. No visual damage was observed.

NOEC seedling emergence and survival of seedlings was at or above 1000 mg/kg soil dw for all species.

Shoot weight was reduced significantly at test item concentrations ≥198 mg/kg soil in S. lycopersicum, B. napus (but not for the 3 intermediate concentrations), and A. sativa (but not for the second concentration), and at test item concentrations ≥667 mg/kg soil in A. cepa and C. sativus. No effects on shoot weight were observed in P. sativum up to and including 1000 mg/kg soil.

Shoot weight was affected in five test species, with for S. lycopersicum (Lycopersicon esculentum) the lowest NOEC and LOEC <198 and =198 mg/kg soil dw, respectively.

The EC10 and EC50 could only be calculated for A. cepa, 228.2 and 906.6 mg/kg dw, respectively, and for S. lycopersicum, 176.9 and 707.1 mg/kg dw, respectively.

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