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EC number: 401-540-3 | CAS number: 84632-65-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (Official Journal of the European Communities L133, page 95, 30/05/88) without analytical monitoring
- Qualifier:
- according to guideline
- Guideline:
- other: Official Journal of the European Communities L133, page 95, 30/05/88.
- Deviations:
- yes
- Remarks:
- , CaCO3 added to correct soil pH was about 8 % of the soil dry weight
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: A stock mixture was prepared for each test concentration by premixing the corresponding amount of test substance with 200 g of fine quartz sand. The dry stock mixtures were mixed with the dry premixed artificial soil in a HOBART-blender. Then the required amount of water to obtain the specified moisture content (200 - 500 % of dry weight of substrate) was added. The blend was dispensed into the test vessels and the worms added.
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworm
- Source: Farm-Research, Wehr, Germany
- Age at test initiation: Adult mature with clitellum (> 2 months of age)
- Weight at test initiation: 194 - 268 g (based on 10 worms per conc. and blank)
- Keeping: Earthworms arriving from the supplier were kept for 42 days in the original soil before the start of the 24h-conditioning.
ACCLIMATION
- Acclimation period: 24 h
- Acclimation conditions: Same as test - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 14 d
- Test temperature:
- 20 ± 1 °C
- pH:
- 6.4 - 6.5
- Moisture:
- 29 - 37 %
- Details on test conditions:
- TEST SYSTEM
- Test container: Beakers of 1 liter filled with 750 g soil (wet weight), covered with perforated plastic film
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of controls: 4
OTHER TEST CONDITIONS
- Photoperiod: Continuous illumination / 400 - 800 lux
EFFECT PARAMETERS MEASURED: Mortality
VEHICLE CONTROL PERFORMED: no
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3 - Nominal and measured concentrations:
- Nominal: 12.3, 37, 111, 333 and 1000 mg/kg dry weight of soil
- Reference substance (positive control):
- no
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- - Mortality at end of exposure period: 0 % in the highest concentration
- Mortality in controls: 0 % - Validity criteria fulfilled:
- yes
- Conclusions:
- In an acute earthworm toxicity study, the substance did not cause toxic effects up to a concentration of 1000 mg/kg soil.
- Executive summary:
The substance's toxicity to soil macroorganisms was investigated in an acute earthworm toxicity study that was GLP-compliant.
Earthworms (eisenia foetida) were exposed to the concentrations of
12.3, 37, 111, 333, 1000 mg test substance/kg (dry weight of soil) for 14 days. In addition, a concurrent negative control group was tested.
The group size was 40 earthworms per concentration.
Mortalities and flaccidity of were observed after 7 and 14 days exposure.
The substance did not induce any acute toxic effects.
- Endpoint:
- toxicity to soil macroorganisms except arthropods: 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 soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (Official Journal of the European Communities L133, page 95, 30/05/88) 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:
- other: Official Journal of the European Communities L133, page 95, 30/05/88.
- Deviations:
- yes
- Remarks:
- , CaCO3 added to correct soil pH was about 8 % of the soil dry weight
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: A stock mixture was prepared for each test concentration by premixing the corresponding amount of test substance with 200 g of fine quartz sand. The dry stock mixtures were mixed with the dry premixed artificial soil in a HOBART-blender. Then the required amount of water to obtain the specified moisture content (200 - 500 % of dry weight of substrate) was added. The blend was dispensed into the test vessels and the worms added.
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworm
- Source: Farm-Research, Wehr, Germany
- Age at test initiation: Adult mature with clitellum (> 2 months of age)
- Weight at test initiation: 194 - 268 g (based on 10 worms per conc. and blank)
- Keeping: Earthworms arriving from the supplier were kept for 42 days in the original soil before the start of the 24h-conditioning.
ACCLIMATION
- Acclimation period: 24 h
- Acclimation conditions: Same as test - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 14 d
- Test temperature:
- 20 ± 1 °C
- pH:
- 6.4 - 6.5
- Moisture:
- 29 - 37 %
- Details on test conditions:
- TEST SYSTEM
- Test container: Beakers of 1 liter filled with 750 g soil (wet weight), covered with perforated plastic film
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of controls: 4
OTHER TEST CONDITIONS
- Photoperiod: Continuous illumination / 400 - 800 lux
EFFECT PARAMETERS MEASURED: Mortality
VEHICLE CONTROL PERFORMED: no
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3 - Nominal and measured concentrations:
- Nominal: 12.3, 37, 111, 333 and 1000 mg/kg dry weight of soil
- Reference substance (positive control):
- no
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- - Mortality at end of exposure period: 0 % in the highest concentration
- Mortality in controls: 0 % - Validity criteria fulfilled:
- yes
- Conclusions:
- In an acute earthworm toxicity study, the substance did not cause toxic effects up to a concentration of 1000 mg/kg soil.
- Executive summary:
The substance's toxicity to soil macroorganisms was investigated in an acute earthworm toxicity study that was GLP-compliant.
Earthworms (eisenia foetida) were exposed to the concentrations of
12.3, 37, 111, 333, 1000 mg test substance/kg (dry weight of soil) for 14 days. In addition, a concurrent negative control group was tested.
The group size was 40 earthworms per concentration.
Mortalities and flaccidity of were observed after 7 and 14 days exposure.
The substance did not induce any acute toxic effects.
Referenceopen allclose all
Description of key information
In an acute earthworm toxicity study, the substance did not cause toxic effects up to a concentration of 1000 mg/kg soil dw.
Key value for chemical safety assessment
Additional information
No key value is indicated, as the substance was not acutely toxic up to 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.
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