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Toxicity to terrestrial plants

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Endpoint:
toxicity to terrestrial plants: long-term
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2019
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Detailed information covering the calculation model, compositional data used as input, validity, applicability and adequacy of the result are in the attached document.
The registered substance is a complex hydrocarbon UVCB whose constituents have variable physicochemical properties. Therefore, a modelling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole.
The target lipid model (TLM) is a framework that relates toxicity to the physicochemical properties of a nonpolar organic constituent. The TLM, and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. This framework utilizes organic carbon partition coefficients (KOC) to convert aquatic based effect levels (CW) to bulk soil- and sediment-based effect levels. The combined TLM-EqP framework was validated previously for soil and sediment acute and chronic toxicity endpoints. The constituents in this substance are within the scope of the TLM and EqP frameworks.
Qualifier:
no guideline required
Principles of method if other than guideline:
The target lipid model (2015) and equilibrium partitioning model as described in the cited references were used to determine soil or sediment effect levels following an estimation of initial loading of the registered substance and its constituents in the substrate. A full explanation of the calculation method is provided in the 'attached justification'.

For model description and justification of QSAR prediction: see fields 'justification for type of information' and 'attached justification'
Species:
Brassica rapa
Plant group:
Dicotyledonae (dicots)
Species:
Avena sativa
Plant group:
Monocotyledonae (monocots)
Species:
Avena sativa
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
12 750 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Avena sativa
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
2 443 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks on result:
other: chronic endpoints were estimated using typical acute-to-chronic ratio of 5.22 (McGrath et al., 2018)
Species:
Brassica rapa
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
8 191 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Remarks on result:
other: chronic endpoints were estimated using typical acute-to-chronic ratio of 5.22 (McGrath et al., 2018)
Species:
Brassica rapa
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1 569 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks on result:
other: chronic endpoints were estimated using typical acute-to-chronic ratio of 5.22 (McGrath et al., 2018)
Validity criteria fulfilled:
yes
Conclusions:
The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics estimated 14-day LC50 value is 12750 mg/kg soil dw based on seedling emergence and the 21-day EC10 value is 2443 mg/kg soil dw based on growth for the terrestrial plant monocot species Avena sativa.
The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics estimated 14-day LC50 value is 8191 mg/kg soil dw based on seedling emergence and the 21-day EC10 value is 1569 mg/kg soil dw for the terrestrial plant dicot species Brassica rapa.
The values were estimated using the Petrotox computer model.
Executive summary:

The registered substance is a complex hydrocarbon UVCB whose constituents have variable physicochemical properties. Therefore, a modeling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole. The target lipid model (TLM) and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. As such, modeled data are considered fit for purpose.

Endpoint:
toxicity to terrestrial plants: short-term (with study design considered suitable for long-term assessment)
Remarks:
OECD 227
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
15 October - 20 November 2020
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Relative humidity decreased below (40.9%) the range specified in the test guideline (70+/- 25%). However, it is determined that this deviation did not affect the validity of the study
Qualifier:
according to guideline
Guideline:
OECD Guideline 227 (Terrestrial Plant Test: Vegetative Vigour Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 30,000 mL test item /ha (highest test rate)
- Sampling method: three 50mL aliquots taken from the highest rate of the test item immediately prior to each of the separate applications
- Sample storage conditions before analysis: Aliquots were frozen within 1 hour of application and stored frozen until completion of the study
Vehicle:
no
Details on preparation and application of test substrate:
- Method of application to filter paper (if used): N/a
- Method of mixing into soil (if used): N/a
- Method of application to soil surface (if used): sprayer with an even flat fan nozzle at 62cm above soil surface
- Controls: deionised water control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not used
- Concentration of vehicle in test medium (stock solution and final test solution): N/a
- Evaporation of vehicle before use: N/a
Species:
Allium cepa
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
- Common name: onion
- Plant family: Liliaceae
- Variety: White Lisbon
- Source of seed: Moles Seeds (UK) Ltd, Turkey Cock Lane, Stanway, Colchester, Essex, CO3 8PD
- Prior seed treatment/sterilization: Seeds were not coated with an insecticide or fungicide and no plant protection products have been used.
- Historical germination of seed (germination of seed lot tested): Plants used for the vegetative vigour test had 2 - 4 true leaves at the time of application
- Seed storage: Not reported
Species:
Zea mays
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
- Common name: Maize
- Plant family: Asteraceae
- Variety: Minipop
- Source of seed: E.W. King & Co Ltd, Kelvedon, CO5 9PG, United Kingdom
- Prior seed treatment/sterilization: The seeds were not coated with an insecticide or fungicide and no plant protection products have been used
- Historical germination of seed (germination of seed lot tested): Plants used for the vegetative vigour test had 2 to 4 true leaves at the time of application
- Seed storage: Not reported
Species:
other: Tagetes patula
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: Marigold
- Plant family: Asteraceae
- Variety: Superhero spry
- Source of seed: Moles Seeds (UK) Ltd, Turkey Cock Lane, Stanway, Colchester, Essex, CO3 8PD
- Prior seed treatment/sterilization: Seeds were not coated with an insecticide or fungicide and no plant protection products have been used.
- Historical germination of seed (germination of seed lot tested): Plants used for the vegetative vigour test had 2 - 4 true leaves at the time of application
- Seed storage: Not reported
Species:
other: Pelargonium hortorum
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: Geranium
- Plant family: Geraniaceae
- Variety: Landscaper red
- Source of seed: Moles Seeds (UK) Ltd, Turkey Cock Lane, Stanway, Colchester, Essex, CO3 8PD
- - Prior seed treatment/sterilization: Seeds were not coated with an insecticide or fungicide and no plant protection products have been used.
- Historical germination of seed (germination of seed lot tested): Plants used for the vegetative vigour test had 2 - 4 true leaves at the time of application
- Seed storage: Not reported
Species:
other: Salvia splendens
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: Salvia
- Plant family: Lamiaceae
- Variety: Vanguard
- Source of seed: Moles Seeds (UK) Ltd, Turkey Cock Lane, Stanway, Colchester, Essex, CO3 8PD
- Prior seed treatment/sterilization: Seeds were not coated with an insecticide or fungicide and no plant protection products have been used.
- Historical germination of seed (germination of seed lot tested): Plants used for the vegetative vigour test had 2 - 4 true leaves at the time of application
- Seed storage: Not reported
Species:
Lycopersicon esculentum
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: Tomato
- Plant family: Solanaceae
- Variety: Sungold
- Source of seed: Moles Seeds (UK) Ltd, Turkey Cock Lane, Stanway, Colchester, Essex, CO3 8PD
- Prior seed treatment/sterilization: Seeds were not coated with an insecticide or fungicide and no plant protection products have been used.
- Historical germination of seed (germination of seed lot tested): Plants used for the vegetative vigour test had 2 - 4 true leaves at the time of application
- Seed storage: Not reported
Test type:
vegetative vigour test
Study type:
laboratory study
Substrate type:
other: Sandy loam soil supplied by Garden Topsoil Direct. Sand supplied by A&S Aggregates
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
None
Test temperature:
18.1-26.6 degrees C
pH:
Not reported
Moisture:
40.9-74.9%. The relative humidity decreased (minimum value 40.9%) below the range specified in OECD test guideline 227 (70±25%) during the test. However, as control plants were healthy and the validity criteria were met, it was determined that this deviation did not affect the validity of the study.
Details on test conditions:
TEST SYSTEM
- Testing facility: Greenhouse
- Test container (type, material, size): Non-porous plastic pots, 15 cm +/- 5% diameter
- Amount of soil:
- Method of seeding:
- No. of seeds per container: 4 plants per pot (6 for onion)
- No. of plants (retained after thinning): 4 plants per pot (6 for onion)
- No. of replicates per treatment group: 5
- No. of replicates per control: 5
- No. of replicates per vehicle control: No vehicle used

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
Sandy loam soil mixed in a ratio of 2 parts sterile loam to 1 part sand.
Sandy loam soil supplied by Garden Topsoil Direct which is a subsidiary of Boughton Loam & Turf Management, Ltd. The Old Piggeries, Cranford Road, Burton Latimer, Kettering, Northamptonshire, NN16 8UN, United Kingdom
Sand supplied by A&S Aggregates, Butterfly Yard, Old Ipswich Road, Colchester CO7 7QR, United Kingdom

NUTRIENT MEDIUM (if used)
- Description: 125g slow-release fertiliser (Osmocote Pro) was incorporated into 30 litres of soil mix.

GROWTH CONDITIONS
- Photoperiod: 16:8 hours light:dark
- Light source: Ambient lighting was supplementing by sodium vapour lamps
- Light intensity and quality: 0.4 - 42.3 KI
- Day/night temperatures: between 18.1 - 26.6 degrees C
- Relative humidity (%): 40.9 - 74.9 %
- Wind velocity: Not reported
- Air exchange rate: Not reported
- Watering regime and schedules: All pots placed in saucers filled with water, sufficient water added to the saucers during the study to ensure that the pots were kept moist at all times.
- Water source/type: Not reported
- Volume applied: Not reported
- Interval of applications: Not reported
- Method of application: water added to saucers which sit underneath plant pots.
- Any pest control method/fertilization (if used): Not reported

ACCLIMATION PERIOD:
Not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Assessed on days 7, 14 and 21 days after application
Mortality, visual phytotoxicity, plant height, dry weight (on day 21)

- Phytotoxicity rating system (if used):
0% no injury
1-39% Slight injury
40-69% moderate injury
70-99% Severe injury
100& all plants dead

VEHICLE CONTROL PERFORMED: no, no vehicle used

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Test concentrations: Not conducted
- Results used to determine the conditions for the definitive study: Not applicable
Nominal and measured concentrations:
Nominal: control, 1875, 3750, 7500, 15000, 30000 mL test substance / ha
Recovery in highest test rate 108.8-110.4%
Reference substance (positive control):
not specified
Species:
Allium cepa
Duration:
21 d
Dose descriptor:
ER50
Effect conc.:
> 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
Allium cepa
Duration:
21 d
Dose descriptor:
other: NOER
Effect conc.:
>= 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
Zea mays
Duration:
21 d
Dose descriptor:
ER50
Effect conc.:
> 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
Zea mays
Duration:
21 d
Dose descriptor:
other: NOER
Effect conc.:
>= 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
other: Tagetes patula
Duration:
21 d
Dose descriptor:
ER50
Effect conc.:
> 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
other: Tagetes patula
Duration:
21 d
Dose descriptor:
other: NOER
Effect conc.:
>= 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
other: Pelagonium hortorum
Duration:
21 d
Dose descriptor:
ER50
Effect conc.:
> 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
other: Pelagonium hortorum
Duration:
21 d
Dose descriptor:
other: NOER
Effect conc.:
>= 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
other: Salvia splendens
Duration:
21 d
Dose descriptor:
ER50
Effect conc.:
> 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
other: Salvia splendens
Duration:
21 d
Dose descriptor:
other: NOER
Effect conc.:
>= 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
Lycopersicon esculentum
Duration:
21 d
Dose descriptor:
ER50
Effect conc.:
> 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Species:
Lycopersicon esculentum
Duration:
21 d
Dose descriptor:
other: NOER
Effect conc.:
>= 30 000 other: ml/ha
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, phytotoxicity, plant height and weight
Details on results:
VEGETATIVE VIGOUR
- Percent seed germination: Not applicable
- Plant height: Onion: 31.4-33.8cm Maize: 79.4-85.8cm Marigold: 13.2-14.3cm Geranium: 10.9-12.8cm Salvia: 13.2-14.3cm Tomato: 68.6-72.2cm
- Dry weight: Onion: 0.126-0.161g Maize: 1.22-1.51g Marigold: 0.432-0.543g Geranium: 0.464-0.620g Salvia: 0.322-0.379g Tomato: 1.61-1.70g
- Abnormal seed development or appearance: Not reported
- Lesions: Not reported
- Swelling: Not reported
- Loss of turgor: Not reported
- Discoloration: Not reported
- Unusual leaf/plant shape or size: Not reported
- Dead plants: 100% survival in all treatments and all species
- Other effects: 0% phytotoxicity according to rating system below

INJURY RATING SYSTEM:
0% no injury
1-39% slight injury
40-69% moderate injury
70-99% severe injury
100% all plants dead
Results with reference substance (positive control):
Not reported
Reported statistics and error estimates:
Statistical analysis carried ou tusing validated CETIS v1.9.2 software
NOER calculated using Dunnett's Multiple Comparison

Rate

mL GS1927/ha

Onion

Maize

Marigold

Geranium

Salvia

Tomato

Height (cm)

Weight (g)

Height (cm)

Weight (g)

Height (cm)

Weight (g)

Height (cm)

Weight (g)

Height (cm)

Weight (g)

Height (cm)

Weight (g)

0

31.7

0.126

84.7

1.39

14.3

0.529

11.1

0.464

13.8

0.367

69.2

1.61

1875

33.8

0.161

80.5

1.32

13.2

0.491

12.3

0.529

13.2

0.322

70.9

1.67

3750

31.4

0.131

79.4

1.16

13.8

0.543

12.8

0.620

13.7

0.360

68.6

1.70

7500

33.1

0.152

80.1

1.22

13.8

0.509

12.0

0.552

14.2

0.379

69.1

1.68

15000

31.7

0.150

85.8

1.51

13.8

0.465

11.8

0.548

14.3

0.368

72.2

1.66

30000

32.4

0.145

82.0

1.30

13.6

0.432

10.9

0.502

13.4

0.336

70.4

1.63
Validity criteria fulfilled:
yes
Conclusions:
21-day ER50 and NOER values of >30,000 and ≥30,000 ml/ha (nominal concentration, highest concentration tested) have been determined for the effects of the test substance, GS1927, on the mortality, phytotoxicity and plant height and weight of six plant species: Allium cepa (onion), Zea mays (maize), Tagetes patula (marigold), Pelagonium hortorum (geranium), Salvia splendens (salvia) and Lycopersicon esculentum (tomato)
Executive summary:

Introduction

A study was performed to determine the potential effects of the test substance on mortality, phytotoxicity, plant height and weight.

Six seedling species, from a range of selected higher plants (monocotyledonae and dicotyledonae species), were exposed to the test substance incorporated into the test substrate. This study was conducted according to the procedures outlined in the study protocol. The protocol was based on the procedures specified in OECD Guideline 227 (OECD, 2006) (Terrestrial Plants Test: Vegetative Vigour Test).

 

Methods

A definitive test was conducted at the following treatment rates: 0 (control), 1875, 3750, 7500, 15000 and 30000 mg test substance/ha, for a period of 21 days after seedling emergence.

The test substance was applied using a sprayer at 62cm above the soil surface.

Five replicate vessels were prepared for each treatment rate with four plants (six for onion) per vessel.

Assessment of effects on mortality, phytotoxicity and plant height and weight were conducted in comparison with the control treatment.

 

Results

The no observable effect rate (NOER) and the ER50 values were determined for mortality, phytotoxicity and plant height and weight.

Based on nominal concentrations of the test substance, the results are as follows:

Species

Common name

ER50

(ml GS1927 /ha)

NOER

(ml GS1927 /ha)

Allium cepa

Onion

>30000

≥30000

Zea mays

Maize

>30000

≥30000

Tagetes patula

Marigold

>30000

≥30000

Pelargonium hortorum

Geranium

>30000

≥30000

Salvia splendens

Salvia

>30000

≥30000

Lycopersicon esculentum

Tomato

>30000

≥30000

Description of key information

The registered substance is a complex hydrocarbon UVCB whose constituents have variable physicochemical properties. Therefore, a modeling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole. The target lipid model (TLM) and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. As such, modelled data are considered fit for purpose.

Detailed information covering the calculation model, compositional data used as input, validity, applicability and adequacy of the result are attached in section 13.2 of IUCLID.

Results from a supporting study (OECD 227) for the registered substance are available. A 21-day ER50 >30,000 ml/ha and NOER ≥ 30,000 ml/ha, effects on mortality, phytotoxicity and plant height and weight (nominal concentration, highest concentration tested). The study met the validity criteria outlined in OECD test guideline 227 and was conducted in accordance with GLP.

Key value for chemical safety assessment

Additional information

A supporting OECD 227 study has been conducted for the registered substance Hydrocarbons, C11-C16, n-alkanes, isoalkane, <2% aromatics (GS1927). 21-day ER50 and NOER (no observed effect rate) values of >30,000 and ≥30,000 ml/ha (nominal concentration, highest concentration tested) have been determined for the effects of the test substance, GS1927, on the mortality, phytotoxicity and plant height and weight of six plant species: Allium cepa (onion), Zea mays (maize), Tagetes patula (marigold),Pelagonium hortorum (geranium), Salvia splendens (salvia) and Lycopersicon esculentum (tomato) (AgroChemex Ltd, 2020). The study was conducted in compliance with GLP (including certificate), according to OECD test guideline 227 and met the validity criteria: seedling emergence was at least 70% (100%), control plants did not exhibit phytotoxic effects, mean plant survival was at least 90% in the controls (100%) and environmental conditions, including substrate characteristics, were identical between treatments.

 

The test concentrations were analysed using GC-FID. Recovery rates were between 80-120% of nominal concentrations, therefore results are reported in terms of the nominal rates. The relative humidity decreased (minimum value 40.9%) below the range specified in OECD test guideline 227 (70±25%) during the test. However, as control plants were healthy and the validity criteria were met, it was determined that this deviation did not affect the validity of the study.