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EC number: 251-311-5 | CAS number: 32961-44-7
- 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
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:
- 2016-06-30 - 2016-08-04 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- version dated 13-Apr-2004
- Deviations:
- yes
- Remarks:
- One more treatment was used in the main test than indicated in the study plan (6 instead of 5 treatments). This represents a deviation of the study plan which is not considered to have an influence on the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Mainzer Straße 80, D65189 Wiesbaden
Test material
- Reference substance name:
- Isobutyl 4-chloro-3,5-diaminobenzoate
- EC Number:
- 251-311-5
- EC Name:
- Isobutyl 4-chloro-3,5-diaminobenzoate
- Cas Number:
- 32961-44-7
- Molecular formula:
- C11H15ClN2O2
- IUPAC Name:
- 2-methylpropyl 3,5-diamino-4-chlorobenzoate
- Test material form:
- solid
- Details on test material:
- - Other: Storage conditions: Ambient temperature, protected from light
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 5, 10, 20, 40, 80 mg/L
- Sample storage conditions before analysis: The supporting analyses could not be performed on the same day of collection of the specimens. Therefore, these specimens from freshly prepared test solutions were stored deep-frozen, thawed over-night and then analysed.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item was weighed in ELENDT M4 dilution water whilst stirring on a magnetic stirrer and shaking on a shaking machine at room temperature. Additionally ultrasonic treatment for 4*10 minutes was necessary to dissolve the test item sufficiently in the test medium. Before weighing the substance into the vessels for treatment preparation it was milled in a mortar made of porcelain.
- Controls: medium without any test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none stated
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna STRAUS (clone 5)
- Source: obtained from Dr. M. Bergtold, BASF, D-67117 Limburgerhof; the strain originally derived from the Institut National de Recherche Chimique Appliquee, France in 1978
- Feeding during test: no
ACCLIMATION
- Acclimation period: The cultivation of the daphnia is performed in a way that the animals are transferred in new test medium at an interval of 1 to 3 days followed by feeding.
- Type and amount of food: Desmodesmus subspicatus- and/or Chlorella-cells
- Health during acclimation (any mortality observed): none stated
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Daphnias used for the test are not older than 24 hr. Therefore, in every case, daphnia are transferred into fresh medium one day before starting of the daphnia test in order to get daphnia for the test younger than 24 hr.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
Test conditions
- Test temperature:
- 20 ± 1°C
- pH:
- 7.89 - 8.33 during definitive main test (8.02 - 8.85 during screening test)
- Dissolved oxygen:
- 8.2 - 8.5 mg O2/L during definitive main test (8.2 - 8.5 during screening test)
- Nominal and measured concentrations:
- Nominal: 0, 5, 10, 20, 40, 80, 100 mg/L
Found (t0): 0.00, 4.92, 9.38, 18.90, 36.40, 81.28 mg/L
Found (t48h): 0.00, 4.91, 9.52, 17.41, 33.63, 69.33 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 50mL, glass
- 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: Elendt M4 (test medium according to OECD 202); the stock solutions with the macronutrients were individually prepared in ultrapure water (for each salt a separate solution). From these individual stock solutions, the medium was prepared.
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 16 hr of light and 8 hr of darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility, daily
VEHICLE CONTROL PERFORMED: yes, medium only
RANGE-FINDING STUDY
- Test concentrations: 1, 10, 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- To verify the sensitivity of the test system the effect of K2Cr2O7 towards different animals of this breed was tested prior to beginning of the test.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 8.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- 10.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: no immobilisation noted
- Other adverse effects control: none stated
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none stated
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Limit test: no
- Dose-response test: yes
- ECx: EC50 (24 hr) = 0.9 mg/L
- Other: In order to verify the sensitivity of the test system towards toxic items the effect of potassium dichromate towards different animals of this breed was tested prior to beginning of the test. The value of the EC50 (24 hr) in this period of time was at 0.9 mg/L potassium dichromate. This value is in accordance with the recommendations of 0.6 to 2.1 mg/L K2Cr2O7 given in OECD Guideline 202 (Daphnia sp., Acute Immobilisation Test).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The study was performed according to OECD TG 202 without deviations which may have impact on the validity of the study. Thus, the results were so obtained via a scientifically reasonable method. Hence, there is no doubt that the obtained results are reliable:
Under the conditions used for the test, there was a significant immobilisation of the daphnias at concentrations >10 mg/L (definitive main test).
As a conclusion of the analytical part of this study, it can be stated that the concentrations of the test item remained sufficiently stable during incubation. Based on this, the reported effect concentrations should refer to the nominal concentrations tested. The following EC-values were determined accordingly after 48 hours:
Mobility:
LOEC = 20.0 mg/L
NOEC = 10.0 mg/L
EC50 = 13.1 mg/L
Based on these results, the test item does not need to be classified as acute toxic to the aquatic environment. With regard to chronic toxicity, taking into account the facts that the test item is soluble in water, i.e. above the determined EC50 value, and not readily biodegradable, the test item should be classified as aquatic chronic Cat. 3. - Executive summary:
Isobutyl 4-chloro-3,5-diaminobenzoate was tested for acute toxicity towards daphnia according to OECD-Test Guideline 202 (version dated 13-Apr-2004) in compliance with GLP. In order to investigate the influence of the test item towards the daphnia, the swimming behaviour of the animals was recorded. Under the conditions used for the test, there was a significant immobilisation of the daphnia at concentrations >10 mg/L (main test). As a conclusion of the analytical part of this study, it can be stated that the concentrations of Isobutyl 4-chloro-3,5-diaminobenzoate remained sufficiently stable during incubation of 48hr: After 48 hr recoveries of >80% of the initial t0-concentrations were measured in the treatments. Based on this, the reported effect concentrations should refer to nominal concentrations (geometric mean). The following EC-values (effective concentrations) were determined accordingly:
Basis: Nominal Concentrations [mg/L]
t24hr
t48hr
NOEC
10.0
10.0
LOEC
20.0
20.0
EC10
16.3
8.8
EC20
17.3
10.1
EC50
19.6
13.1
The test is considered valid as all conditions for validity were met.
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