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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 microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-22 to 1990-02-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-study without analytical monitoring
- Qualifier:
- according to guideline
- Guideline:
- other: EEC L133, page 118-122 (30. May 1988)
- Deviations:
- yes
- Remarks:
- Instead of a centrifuged sludge a settled sludge was used. In addition, the substance was given directly to the medium (no stock solution).
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- Activated sludge collected from the sewage treatment plant of CH-4153 Reinach on 1990-02-05. The preparation was carried out according to the method described in the guideline. The sludge was separated from the aqueous layer by settling instead of centrifugation.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Test temperature:
- 20 ± 2°C
- Nominal and measured concentrations:
- Nominal concentrations:
Test substance: 3.35, 4.75, 10.85, 35.5 and 103.9 mg/L
Reference substance: 3.2, 10.0, 32.0 mg/L
The sludge concentration in the test bottles was 1.7 g/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 ml BOD flasks with gas inlet
- Type: closed
- No. of vessels per concentration (replicates): 1
- No. of control vessels: 2
- Water: Dechlorinated drinking water
- Duration: 3 h
Nutrient solution: 16 g Peptone, 11 g Meat extract, 3.0 g Urea, 0.7 g NaCl, 0.4 g CaCl2 x 2 H2O, 0.2 g MgSO4 x 7 H2O, 2.8 g K2HPO4 were dissolved and made up to one liter of dechlorinated drinking water.
- Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Duration:
- 3 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- other: EC80
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Results with reference substance (positive control):
- - Relevant effect levels: EC50 (3h) = 16 mg/L (graphically determined)
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an respiration inhibition test with aerobic bacteria, the substance did not affect the oxygen consumption up to a concentration of 103.9 mg/L.
- Executive summary:
The substance toxicity to microorganisms was investigated with a test on inhibition of respiration (oxygen consumption) of aerobic bacteria.
Five concentrations (3.35, 4.75, 10.85, 35.5, 103.9 mg/L) were tested by adding the respective amount directly to the test medium, which contained 1.7 g/L activated sludge. Oxygen consumption was not inhibited at any concentration.
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-22 to 1990-02-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-study 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 both forms form non-dispersible aggregates in aqueous milieu, read-across of aquatic toxicity studies from the source to the target form is scientifically justified.
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: EEC L133, page 118-122 (30. May 1988)
- Deviations:
- yes
- Remarks:
- Instead of a centrifuged sludge a settled sludge was used. In addition, the substance was given directly to the medium (no stock solution).
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- Activated sludge collected from the sewage treatment plant of CH-4153 Reinach on 1990-02-05. The preparation was carried out according to the method described in the guideline. The sludge was separated from the aqueous layer by settling instead of centrifugation.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Test temperature:
- 20 ± 2°C
- Nominal and measured concentrations:
- Nominal concentrations:
Test substance: 3.35, 4.75, 10.85, 35.5 and 103.9 mg/L
Reference substance: 3.2, 10.0, 32.0 mg/L
The sludge concentration in the test bottles was 1.7 g/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 ml BOD flasks with gas inlet
- Type: closed
- No. of vessels per concentration (replicates): 1
- No. of control vessels: 2
- Water: Dechlorinated drinking water
- Duration: 3 h
Nutrient solution: 16 g Peptone, 11 g Meat extract, 3.0 g Urea, 0.7 g NaCl, 0.4 g CaCl2 x 2 H2O, 0.2 g MgSO4 x 7 H2O, 2.8 g K2HPO4 were dissolved and made up to one liter of dechlorinated drinking water.
- Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Duration:
- 3 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- other: EC80
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Results with reference substance (positive control):
- - Relevant effect levels: EC50 (3h) = 16 mg/L (graphically determined)
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an respiration inhibition test with aerobic bacteria, the substance did not affect the oxygen consumption up to a concentration of 103.9 mg/L.
- Executive summary:
The substance toxicity to microorganisms was investigated with a test on inhibition of respiration (oxygen consumption) of aerobic bacteria.
Five concentrations (3.35, 4.75, 10.85, 35.5, 103.9 mg/L) were tested by adding the respective amount directly to the test medium, which contained 1.7 g/L activated sludge. Oxygen consumption was not inhibited at any concentration.
Referenceopen allclose all
Description of key information
In an respiration inhibition test with aerobic bacteria, the substance did not affect the oxygen consumption up to a concentration of 103.9 mg/L.
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 103.9 mg/L
Additional information
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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