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EC number: 500-300-6 | CAS number: 111411-00-8
- 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:
- 26 March 2018 - 22 May 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
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-aminomethyl-3,5,5-trimethylcyclohexylamine
- EC Number:
- 220-666-8
- EC Name:
- 3-aminomethyl-3,5,5-trimethylcyclohexylamine
- Cas Number:
- 2855-13-2
- Molecular formula:
- C10H22N2
- IUPAC Name:
- 3-(aminomethyl)-3,5,5-trimethylcyclohexanamine
- Reference substance name:
- 4-tert-butylphenol
- EC Number:
- 202-679-0
- EC Name:
- 4-tert-butylphenol
- Cas Number:
- 98-54-4
- Molecular formula:
- C10H14O
- IUPAC Name:
- 4-tert-butylphenol
- Reference substance name:
- 2-(((5-amino-1,3,3-trimethylcyclohexyl)methylamino)methyl)-4-tert-butylphenol
- Molecular formula:
- C21H36N2O
- IUPAC Name:
- 2-(((5-amino-1,3,3-trimethylcyclohexyl)methylamino)methyl)-4-tert-butylphenol
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control, 10, 18, 32, 56 and 100 mg/L loading rate WAF
- Sample storage conditions before analysis: The samples were stored frozen prior to analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Nominal amounts of test item (50, 90, 160, 280 and 500 mg) were each separately added to the surface of 5 liters of test water to give the 10, 18, 32, 56 and 100 mg/L loading rates respectively. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixtures allowed to stand for 1-Hour. Microscopic observations made on the WAFs indicated that a significant amount of dispersed test item was present in the water column and hence it was considered justifiable to remove the WAFs by filtering through a glass wool plug (2 to 4 cm in length). A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75 to 100 mL discarded) to give the 10, 18, 32, 56 and 100 mg/L loading rate WAFs. Microscopic observations of the WAFs were performed after filtering and showed no microdispersions of test item present.
The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 and 48 hours.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5, originally supplied by University of Sheffield/UK
- Source: in-house laboratory cultures
- Feeding during test: no
ACCLIMATION
- Acclimation conditions: Elendt M7 medium
- Type and amount of food: Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension.
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20 °C to 22 °C
- pH:
- 8.1 - 9.2 at test start, 7.7-8.1 at test end
- Dissolved oxygen:
- 8.6-8.7 mg O2/L at test start, 8.8 - 8.9 mg O2/L at test end
- Nominal and measured concentrations:
- 10, 18, 32, 56 and 100 mg/L loading rate WAF
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 mL beakers containing approximately 100 mL of test preparation
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h darkness with 20 minute dawn and dusk transition periods
- Light intensity: 675 to 740 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilization or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure
RANGE-FINDING STUDY
- Test concentrations: Control, 0.010, 0.10, 1.0, 10 and 100 mg/L loading rate WAF
- Results used to determine the conditions for the definitive study:
No sub-lethal effects of exposure were observed throughout the test.
No immobilization was observed at 0.010, 1.0 and 10 mg/L loading rate WAF, however, immobilization was observed at 0.10 and 100 mg/L loading rate WAF.
Based on this information loading rates of 10, 18, 32, 56 and 100 mg/L were selected for the definitive test. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 21 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- loading rate WAF
- Basis for effect:
- mortality
- Remarks on result:
- other: 95% Confidence limits
- Remarks:
- 19-24 mg/L loading rate WAF
- Details on results:
- - Other biological observations: No sub-lethal effects of exposure were observed throughout the test at 10 mg/L loading rate WAF.
Sub-lethal effects of exposure were observed in the 18 mg/L loading rate WAF. These responses were reduced mobility and pale appearance.
- Mortality of control: none of the control daphnids showed immobilization or other signs of disease or stress
- Effect concentrations exceeding solubility of substance in test medium:
At the start of the mixing period the 10, 18 and 32 mg/L loading rates were observed to be clear colorless water columns with tiny globules of test item on surface whilst the 56 and 100 mg/L loading rates were observed to be clear colorless water columns with large and small globules of test item on surface. After 23 hours stirring and a 1-Hour standing period the 10, 18 and 32 mg/L loading rates were observed to be clear colourless water columns with small globules of test item on the surface. The 56 and 100 mg/L loading rates were observed to be clear colourless water columns with globules of test item on the surface.
Microscopic examination of the WAFs showed micro-dispersions of test item present and therefore it was considered justifiable to remove the WAFs by filtering through a glass wool plug (2 to 4 cm in length). Microscopic examination after filtering showed the glass wool plug had removed all the undissolved test item. After siphoning and for the duration of the test, all loading rates were observed to be clear, colorless solutions. - Results with reference substance (positive control):
- - Results with reference substance valid?
yes
24 h EC50 = 0.79 mg/L, 95% c.l. 0.73-0.86 mg/L
48 h EC50 = 0.75 mg/L, 95% c.i. 0.56-1.0 mg/L
The results from the positive control with potassium dichromate were within the normal range for this reference item. The results of the inter laboratory tests and a Technical Corrigendum to ISO 6341 give a 24-Hour EC50 for potassium dichromate within the range 0.6 mg/L to 2.1 mg/L. - Reported statistics and error estimates:
- The EL50 values and associated confidence limits at 24 hours were calculated by the binomial method. The EL50 values and associated confidence limits at 48 hours were calculated using the Trimmed Spearman-Karber method. The Lowest Observed Effect Loading Rate (LOEL) and the No Observed Effect Loading Rate (NOEL) at 24 and 48 hours were calculated using the Fisher’s Exact Binomial Test with Bonferroni correction. All results were calculated using the ToxRat Professional computer software package (TOXRAT).
Any other information on results incl. tables
Validity criteria:
The test was considered to be valid given that none of the control daphnids showed immobilization or other signs of disease or stress and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels.
Cumulative Immobilization Data and Observations in the Definitive Test
Nominal Loading Rate (mg/L) |
24 Hours |
|||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
|||||||||
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Total |
% |
Rep1 |
Rep2 |
Rep3 |
Rep4 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
18 |
0 |
0 |
0 |
0 |
0 |
0 |
1 R 4 N |
3 R 2 N |
2 R 3 N |
2 R 3 N |
32 |
5 |
5 |
5 |
5 |
20 |
100 |
AI |
AI |
AI |
AI |
56 |
5 |
5 |
5 |
5 |
20 |
100 |
AI |
AI |
AI |
AI |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
AI |
AI |
AI |
AI |
Nominal Loading Rate (mg/L) |
48 Hours |
|||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
|||||||||
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Total |
% |
Rep1 |
Rep2 |
Rep3 |
Rep4 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
18 |
1 |
1 |
0 |
2 |
4 |
20 |
1 P 1 R 2 N |
2 P 2 R |
2 P 3 R |
2 P 1 R |
32 |
5 |
5 |
5 |
5 |
20 |
100 |
AI |
AI |
AI |
AI |
56 |
5 |
5 |
5 |
5 |
20 |
100 |
AI |
AI |
AI |
AI |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
AI |
AI |
AI |
AI |
Rep = Replicate
N = Normal
P = Pale
R = Reduced mobility
AI = All daphnia immobilized
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of the freshwater invertebrate Daphnia magna to the test item has been investigated and gave the following results: 48 h EL50 = 21 mg/L loading rate WAF (95% Confidence Limits 19-24 mg/L loading rate WAF).
- Executive summary:
This study was performed to assess the acute toxicity of Mannich base IPDA-PTBP to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range-finding test, 20 daphnids (4 replicates of 5 animals) were exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 10, 18, 32, 56 and 100 mg/L for 48 hours at a temperature of 20 °C to 22 °C under static test conditions. The number of immobilized daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.
Chemical analysis of the fresh test preparations at 0 hours showed measured test concentrations to range from 4.8 to 24 mg/L. Chemical analysis of the aged test preparations at 48 hours showed measured test concentrations to range from 3.8 to 19 mg/L.
The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of Daphnia magna to the test item gave the following results: 48 h EL50 = 21 mg/L loading rate WAF (95% Confidence Limits 19-24 mg/L loading rate WAF).
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