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Diss Factsheets
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EC number: 231-617-5 | CAS number: 7652-64-4
- 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
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Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 - 27 Mar, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1'-(1,3-phenylenedicarbonyl)bis[2-methylaziridine]
- EC Number:
- 231-617-5
- EC Name:
- 1,1'-(1,3-phenylenedicarbonyl)bis[2-methylaziridine]
- Cas Number:
- 7652-64-4
- Molecular formula:
- C14H16N2O2
- IUPAC Name:
- 2-methyl-1-[3-(2-methylaziridine-1-carbonyl)benzoyl]aziridine
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Physical state: viscous colorless liquid or solid at room temperature (22-23 °C)
- Source and lot/batch No.of test material: Lot 10115
- Expiration date of the lot/batch: 10 Jan 2019
- Purity: 95.6%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: frozen
FORM AS APPLIED IN THE TEST: solid. The test material did not liquefy after being brought to room temperature.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All; sampled at test initiation, 24 hours, and at test termination. At 24 hours (renewal), both spent and new solutions were sampled.
- Sampling method: Samples were collected from middepth, placed in glass vials containing 2.00 mL of 0.5% formic acid in methanol, and processed immediately for analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A primary stock solution was prepared by mixing a calculated amount of test substance in 4 L of dilution water at a nominal concentration of 100 mg formulation/L, the highest concentration tested. The stock solution concentration was not adjusted for the active ingredient of the test substance during preparation, and all concentrations are based on the test substance as received. The test substance was weighed onto two pieces of Teflon®, added to a 4 L WAF bottle containing 4 L of dilution water, and stirred for approximately four hours on a magnetic stir plate. A piece of neoprene was placed between the WAF bottle and the stir plate to minimize the potential of a temperature change in the stock solution. The stock solution appeared clear and colorless with white precipitate in the water column. The stock solution was allowed to settle briefly to allow the precipitate to settle out. The solution was drawn off through a spigot and tubing placed approximately 2-3 cm from the bottom of the aspirator bottle (mid-depth) and filtered through a 0.45 μm PTFE filter. Aliquots of the primary stock solution were proportionally diluted with dilution water to a final volume of 1 L to prepare four additional test solutions at nominal concentrations of 6.3, 13, 25 and 50 mg formulation/L. The solutions were stirred on a magnetic stir plate for approximately 15 minutes, and approximately 220 mL of solution was placed in each of four replicate test chambers per treatment group.
- Controls: dilution water
- Evidence of undissolved material: A white precipitate was present in the water column after preparation and stirring. the precipitate was allowed to settle out before the solution was drawn off, filted, and diluted to prepare test solutions.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Cladoceran; Water flea
- Source: Cultures maintained by the test laboratory with known history
- Age at study initiation: < 24 hours, from parental daphnids of more than two weeks old
- Culturing: Adult daphnids were cultured in water from the same source and at approximately the same temperature as used during the test. Adult daphnids in the cultures were held for at least 14 days prior to collection of the juveniles for testing. The adults showed no signs of disease or stress during the holding period. During the 14-day period preceding the test, water temperatures ranged from 19.6 to 20.8 °C. The pH of the water ranged from 8.1 to 8.4, and dissolved oxygen concentrations were ≥ 7.7 mg/L. Daphnids in the cultures were fed a mixture of yeast, cereal grass media and trout chow, supplemented with a vitamin stock solution and a suspension of the freshwater green algae, Raphidocelis subcapitata.. The adults were fed prior to test initiation, but neonates were not fed during the test.
FEEDING DURING TEST
- Food type: Not fed during test
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 144 mg CaCO3/L
- Test temperature:
- 19.7 - 20.1 °C
- pH:
- 8.0 - 8.4
- Dissolved oxygen:
- 7.0 - 9.1 mg/L
- Conductivity:
- 330 μS/cm
- Nominal and measured concentrations:
- Nominal: 6.3, 13, 25, 50 and 100 mg MTDID 10628/L
Measured: 0.41 (± 0.294), 0.99 (±0.502), 1.9 (±1.06), 4.4 (±1.86) and 9.1 (±4.02) mg formulation/L (geometric mean) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass beaker, loosely covered wtih a plastic petri dish
- Fill volume: approximately 220 mL
- Depth: 7.0 cm
- Aeration: dilution water aerated prior to filling
- Renewal: Once at 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: 40-m deep well located at testing lab. Water was passed through a sand filter and pumped into a storage tank and aerated with spray nozzles. Water was filtered to 0.45 μm and UV-sterilized prior to testing. Periodic water analysis, Attachments 1 and 2.
- Total organic carbon: < 1 mg C/L
- Pesticides: all < LOQ
- Alkalinity: 186 mg CaCO3/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: most recent analysis on samples collected 20 Dec 2017
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h:8h with 30-min transitions
- Light intensity: 449 lux at surface of water of one representative chamber at test initiation
EFFECT PARAMETERS MEASURED : Mortality and immobilization at 24h and 48 h
RANGE-FINDING STUDY
- Test concentrations: 1.2, 3.7, 11, 33 and 100 mg formulation/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- no
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 9.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: 9.1 mg/L was considered the maximum soluble concentration in test medium. Test conducted at a loading rate of 100 mg/L.
- Details on results:
- - Behavioural abnormalities: Lethargy (see Table 2)
- Mortality of control: None
Any other information on results incl. tables
Table 2. Cumulative percent mortality/immobility.
Nominal concentration (mg formulation/L) |
Number Immobile / Observations1 |
Number Immobile / Observations1 |
Number Immobile / Observations1 |
Cumulative Percent Immobilized |
|
~ 3 hours |
24 hours |
48 hours |
|
Negative Control |
0 / 20 AN |
0 / 20 AN |
0 / 20 AN |
0 |
0.41 |
0 / 20 AN |
0 / 20 AN |
0 / 20 AN |
0 |
0.99 |
0 / 20 AN |
0 / 20 AN |
0 / 20 AN |
0 |
1.9 |
0 / 20 AN |
0 / 20 AN |
0 / 2 C; 18 AN |
0 |
4.4 |
0 / 20 AN |
0 / 20 AN |
0 / 3 C; 21 AN |
0 |
9.1 |
0 / 20 AN |
0 / 20 AN |
0 / 8 C; 12 AN |
0 |
1 Observations: AN = appears normal; C = lethargy
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Control immobilization was < 10% at the end of the test. The dissolved oxygen concentration was ≥ 3 mg/L in the control and test vessels throughout the test.
- Conclusions:
- There was no immobilization of Daphnia magna in a 48-hour test with 1,1'-isophthaloylbis(2-methylaziridine) at a nominal concentration of 100 mg/L (OECD 202). The measured geometric mean concentration of 1,1'-isophthaloylbis(2-methylaziridine) was 9.1 mg/L.
- Executive summary:
The 48-hour EC50 of 1,1'-isophthaloylbis(2-methylaziridine) to Daphnia magna was examined in a semi-static test conducted according to OECD 202. Test solutions were prepared at nominal concentrations of 6.3, 13, 25, 50 and 100 mg formulation/L. The associated geometric mean measured concentrations were 0.41, 0.99, 1.9, 4.4, and 9.1 mg formulation/L. No immobilization of the daphnids was observed by 48 hours. The 48-hour EC50 is > 9.1 mg/L based on the measured concentration and > 100 mg/L based on the nominal concentration.
The test was conducted according to internationally accepted test guidelines and was GLP compliant. It is reliable without restriction and suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.
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.
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