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Registration Dossier
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EC number: 401-540-3 | CAS number: 84632-65-5
Ecotoxicological information
Toxicity to terrestrial plants
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Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to terrestrial plants: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-22 to 1990-03-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study according to OECD Guideline 208 without analytical monitoring
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
- Deviations:
- yes
- Remarks:
- , percent of particles < 20 µm were not determined
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Soil: 80 % "Loess" and 20 % fine quartz sand not sterilised soil with the following characteristics : pH 7.5 and carbon content 0.23 %
- Method of mixing into soil (if used): 6.375 g of the test substance were mixed with a small aliquot of dry soil and incorporated into 6579 g of dry soil to obtain a final concentration of 1000 mg of test substance / kg of dry soil. In order to achieve the required test concentrations the stock mixture was blended in a HOBART-blender. After dispensing this blend into the test containers the seeds were planted and covered with a thin layer of testsoil. The water was added subsequently.
- Controls: Blank - Species:
- Lolium perenne
- Plant group:
- Monocotyledonae (monocots)
- Details on test organisms:
- - Common name: Ryegrass
- Plant family: Poaceae
- Source of seed: Eric Schweizer AG, CH-3602 Thun - Species:
- Brassica rapa
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Turnip
- Plant family: Brassicaceae
- Source of seed: Eric Schweizer AG, CH-3602 Thun - Species:
- Vicia sativa
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Common vetch
- Plant family: Fabaceae
- Source of seed: Eric Schweizer AG, CH-3602 Thun - Test type:
- seedling emergence and seedling growth test
- Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 15 d
- Remarks:
- after 50 % of the seedlings have emerged in the blank control
- Test temperature:
- 20 ± 2 °C
- pH:
- 7.5
- Moisture:
- Humidity of soil was maintained during exposure at 65 % water retention capacity (corresponding to 9-19 % humidity in soil) with daily control of weight (pot including soil, water, plant) from monday to friday.
- Details on test conditions:
- TEST SYSTEM
- Testing facility: Growth chamber
- Test container: Non-porous plastic pots (height 9 cm, diameter 9 cm) filled with approximately 450 g of dry soil
- No. of seeds per container: 20
- No. of replicates per treatment group: 1
- No. of replicates per control: 1
GROWTH CONDITIONS
- Photoperiod: 16 h light/ 8 h dark, 2600 - 5000 Lux (52-100 µE/m²sec), cold white fluorescent light
- Air humidity (%): 49 - 78 %
EFFECT PARAMETERS MEASURED: Emergence, growth, symptoms
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10 - Nominal and measured concentrations:
- Nominal: 10, 100 and 1000 mg/kg dry soil
- Reference substance (positive control):
- no
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 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
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 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
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 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
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Details on results:
- SEED GERMINATION
- Percent seed germination in blanks: 90 (Lolium perenne), 95 (Vicia sativa), 70 (Brassica rapa)
- Other effects: None
SEEDLING EMERGENCE
- Abnormal seed development or appearance: None
- Other effects: None - Validity criteria fulfilled:
- yes
- Conclusions:
- In a GLP-study accoring to OECD test guideline, the substance did not show any toxic effects regarding the growth and seedling emergence of three species (Brassica rapa, Lolium perenne and Vicia sativa) at a concentration 1000 mg/kg soil. Therefore, the NOEC is 1000mg/kg soil dw .
- Endpoint:
- toxicity to terrestrial plants: long-term
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
- Endpoint:
- toxicity to terrestrial plants: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-22 to 1990-03-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study according to OECD Guideline 208 without analytical monitoring
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is performed between two forms of the same substance. The identities of the two forms are describe below.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source form is 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrol-1,4-dione (EC-no. 401-540-3), referred to here as PR254. PR254 is an organic mono-constituent substance with a typical purity of > 99.5% (w/w). It does not contain any impurity relevant for classification or labelling of the substance. The target form is the nanoform of the source substance, referred to here as PR254 nanoform. As the source form, it has a typical purity of > 99.5% (w/w) and it does not contain any impurity relevant for classification or labelling of the substance. The PR254 nanoform is spheroidal with a pure polyhedral shape and is not surface-treated.
3. ANALOGUE APPROACH JUSTIFICATION
The two analogue forms have the same structure. Under ambient atmosphere, the specific surface energy of particles increases with decreasing particle size. Therefore, particle aggregate to reach an energy minimum. The driving forces are hydrogen bonds and van der Waals forces (π-π interaction). Substantial energy is required to disperse the PR254 nanoform aggregates to particles that fall under the nanoform definition.
PR254 was been tested extensively addressing information requirements of Annexes VII to IX without identifying any biological target. PR254 nanoform could potentially have biological targets due to the different particle size distribution, which would require processes capable of dispersing the aggregates, e.g. in aqueous milieu. However, both forms have been tested according to OECD Test Guideline 318, demonstrating that PR254 nanoform cannot be dispersed under the condition of the study, i.e. immediately after sonification re-forms aggregates. Also, PR254 aggregates to a large extent, but can be more easily dispersed than the nanoform. The experiments demonstrated that exposure in aqueous milieu will be primarily to aggregates, regardless of the PR254 form.
Therefore, it is concluded that both forms will behave identically in studies, in which they are applied under atmospheric conditions and/or in aqueous milieus, so that for the PR254 nano-form no specific biological targets need to be considered.
As also the environmental fate is identical, read-across is also justified for sediment and terrestrial toxicity.
4. DATA MATRIX
The data matrix is included as Annex 1 in the assessment report ‘PR254 bulk nano analogue approach 210111’ attached here below under ‘Attached justification’. - Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
- Deviations:
- yes
- Remarks:
- , percent of particles < 20 µm were not determined
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Soil: 80 % "Loess" and 20 % fine quartz sand not sterilised soil with the following characteristics : pH 7.5 and carbon content 0.23 %
- Method of mixing into soil (if used): 6.375 g of the test substance were mixed with a small aliquot of dry soil and incorporated into 6579 g of dry soil to obtain a final concentration of 1000 mg of test substance / kg of dry soil. In order to achieve the required test concentrations the stock mixture was blended in a HOBART-blender. After dispensing this blend into the test containers the seeds were planted and covered with a thin layer of testsoil. The water was added subsequently.
- Controls: Blank - Species:
- Lolium perenne
- Plant group:
- Monocotyledonae (monocots)
- Details on test organisms:
- - Common name: Ryegrass
- Plant family: Poaceae
- Source of seed: Eric Schweizer AG, CH-3602 Thun - Species:
- Brassica rapa
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Turnip
- Plant family: Brassicaceae
- Source of seed: Eric Schweizer AG, CH-3602 Thun - Species:
- Vicia sativa
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- - Common name: Common vetch
- Plant family: Fabaceae
- Source of seed: Eric Schweizer AG, CH-3602 Thun - Test type:
- seedling emergence and seedling growth test
- Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 15 d
- Remarks:
- after 50 % of the seedlings have emerged in the blank control
- Test temperature:
- 20 ± 2 °C
- pH:
- 7.5
- Moisture:
- Humidity of soil was maintained during exposure at 65 % water retention capacity (corresponding to 9-19 % humidity in soil) with daily control of weight (pot including soil, water, plant) from monday to friday.
- Details on test conditions:
- TEST SYSTEM
- Testing facility: Growth chamber
- Test container: Non-porous plastic pots (height 9 cm, diameter 9 cm) filled with approximately 450 g of dry soil
- No. of seeds per container: 20
- No. of replicates per treatment group: 1
- No. of replicates per control: 1
GROWTH CONDITIONS
- Photoperiod: 16 h light/ 8 h dark, 2600 - 5000 Lux (52-100 µE/m²sec), cold white fluorescent light
- Air humidity (%): 49 - 78 %
EFFECT PARAMETERS MEASURED: Emergence, growth, symptoms
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10 - Nominal and measured concentrations:
- Nominal: 10, 100 and 1000 mg/kg dry soil
- Reference substance (positive control):
- no
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 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
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Brassica rapa
- Duration:
- 15 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 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
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Lolium perenne
- Duration:
- 15 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 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
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Key result
- Species:
- Vicia sativa
- Duration:
- 15 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Details on results:
- SEED GERMINATION
- Percent seed germination in blanks: 90 (Lolium perenne), 95 (Vicia sativa), 70 (Brassica rapa)
- Other effects: None
SEEDLING EMERGENCE
- Abnormal seed development or appearance: None
- Other effects: None - Validity criteria fulfilled:
- yes
- Conclusions:
- In a GLP-study accoring to OECD test guideline, the substance did not show any toxic effects regarding the growth and seedling emergence of three species (Brassica rapa, Lolium perenne and Vicia sativa) at a concentration 1000 mg/kg soil. Therefore, the NOEC is 1000mg/kg soil dw .
Referenceopen allclose all
Description of key information
The substance was not acutely toxic to plants at a concentration 1000 mg/kg soil dw. Therefore, the EC50 is > 1000mg/kg soil dw .
No long-term plant toxicity study is required (according to column 2 of Annex X of the REACH regulation), as the results of the chemical safety assessment do not indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms.
Key value for chemical safety assessment
Additional information
No key value is indicated, as the substance was not acutely toxic at 1000 mg/kg soil dw, i.e. the short-term EC50 was > 1000 mg/kg soil dw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
