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EC number: 641-048-8 | CAS number: 110839-13-9
- 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:
- 23 March 2018 - 23 July 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:
- 13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3- epoxypropane, reaction products with mphenylenebis(methylamine)
- Cas Number:
- 113930-69-1
- IUPAC Name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3- epoxypropane, reaction products with mphenylenebis(methylamine)
- Test material form:
- solid
- Details on test material:
- - Physical appearance: light amber solid
- Storage of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- - No correction factor for purity was required and therefore not applied.
- The test material is irritant/corrosive.
- The water solubility at 20°C was determined to be <1 mg/L using the flask method.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- For determination of test concentrations in the final test, single samples for possible analysis were taken from additional vessels without organisms from all test concentrations and the control according to the schedule below.
Frequency: at t=0 h and t=48 h
Volume: 20 mL from the approximate centre of the test vessels
Storage: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the test facility
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method: for the combined limit/range-finding test, test solutions were prepared from a saturated solution prepared at a loading rate of 100 mg/L. However, information provided after the performance of the combined limit/range-finding test revealed that the test item is a complex mixture instead of a pure substance. Therefore it was decided to prepare the test solutions for the the final test as individual WAFs. Preparation of test solutions started with loading rates individually prepared ranging between 4.6 and 100 mg/L. A 1-day period of magnetic stirring was applied to ensure maximum dissolution of the test item in medium. The obtained mixtures were allowed to settle for approximately 1 day. Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by means of siphoning and used as test concentrations. All test solutions were clear and colorless at the end of the preparation procedure.
- Controls: Test medium without test item or other additives.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus, 1820
- Source: in-house laboratory culture with a known history. At least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
- Age of parental stock: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
- Age at study initiation: < 24 hours, from parental daphnids of more than two weeks old.
- Feeding during test: no
ACCLIMATION
- Acclimation period: no
BREEDING:
- Method: each batch was started with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium (M7) in an all-glass culture vessel. Cultures were max. 4 weeks old. After 7 days of cultivation half of the medium was renewed twice a week.
- Feeding: daily, a suspension of fresh water algae.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L
- Test temperature:
- 20°C
- pH:
- At t=0 h: 8.0-8.2
At t=48 h: 8.0-8.1 - Dissolved oxygen:
- At t=0 h: 8.1-8.8 mg/L
At t=48 h: 8.5-8.9 mg/L - Nominal and measured concentrations:
- Nominal concentration: WAFs prepared at 4.6, 10, 22, 46 and 100 mg/L
Measured concentration at both t=0 and t=48 h were below the limit of quantification for WAFs prepared at 4.6, 10, 22 and 46 mg/L. The measured concentrations in the WAF prepared at 100 mg/L were 0.711 mg/L and 0.716 mg/L at t=0 and t=48 h, respectively. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL, all-glass
- Fill volume: 50 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Standard medium used: yes, according to OECD 202
- Source/preparation of dilution water: tap water purified by reverse osmosis
- Culture medium different from test medium: yes, M7 was used as culture medium
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: the test was performed in the dark
EFFECT PARAMETERS MEASURED: mobility at 24 and 48 hours.
- Additional measurements: pH and dissolved oxygen at the beginning and at the end of the test, in the limit test concentration and the control. Temperature of the medium: continuously in a temperature control vessel.
COMBINED LIMIT/RANGE-FINDING STUDY: yes, twenty daphnids per concentration (four replicates, 5 daphnids per vessel) were exposed to a control and test concentrations of 1.0, 10 and 100% of the SS prepared at 100 mg/L. At 100% of the SS prepared at 100 mg/L, 10% and 30% of the introduced daphnids became immobilized at t=24 and t=48 h, respectively. A final test was used to confirm the results as interference with the spectrophotometric analysis may have occurred (test samples for test concentration determination were taken from the test system including daphnis which could have interfered). - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (July 2018)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.71 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Details on results:
- Results of test sample analysis (see table 1):
- Recovery of the quality control at the level of 0.5 mg/L was lower than acceptable. However, since the measured concentration of the final test were comparable to those of the combined limit/range-finding test and in line with the water solubility (<1 mg/L), it was considered to have no effect on the results of the analysis.
- The measured concentrations were below the limit of quantification up to and including a WAF prepared at a loading rate of 46 mg/L.
- The measured concentrations in the WAF prepared at the highest loading rate remained constant over the test period (i.e. 0.71 and 0.72 mg/L at t=0 and t=48 h, respectively) and therefore the effect concentration was based on the initially measured concentration.
Results of the final test:
- No immobility was observed in the control and the three lowest test concentrations while 5 and 30% immobility was observed at the two highest test concentrations (see table 2). Based on these observations, the EC50 was determined to exceed the highest concentration tested.
- Abnormal observations: no
- Mortality of control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no, microscopic observation revealed no test item attached to the daphnids.
- Effect concentrations exceeding solubility of substance in test medium: yes
- The experimental conditions remained within the limits prescribed by the study plan and were according to the OECD guideline. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- 48h-EC50: 0.59 mg/L, 95%-confidence interval: 0.53-0.72 mg/L
- Other: results fell within the historical range of the test facility.
Any other information on results incl. tables
Table 1 Measured concentrations in the final test
Time of sampling [hours] |
Percentage of SS* [%] |
Abs. [AU] |
Abs. Cor# [AU] |
Analyzed concentration [mg/L] |
Relative to initial [%] |
n.a. |
blank |
0.0095 |
|
n.d. |
|
|
blank |
0.0098 |
|
n.d. |
|
|
blank |
0.0099 |
|
n.d. |
|
0 |
0 |
0.0070 |
-0.0027 |
< 0.5 |
|
|
4.6 |
0.0113 |
0.0016 |
< 0.5 |
|
|
10 |
0.0111 |
0.0014 |
< 0.5 |
|
|
22 |
0.0155 |
0.0058 |
< 0.5 |
|
|
46 |
0.0233 |
0.0136 |
< 0.5 |
|
|
100 |
0.0306 |
0.0209 |
0.711 |
|
48 |
0 |
0.0060 |
-0.0037 |
< 0.5 |
n.a. |
|
4.6 |
0.0091 |
-0.0006 |
< 0.5 |
n.a. |
|
10 |
0.0105 |
0.0008 |
< 0.5 |
n.a. |
|
22 |
0.0101 |
0.0004 |
< 0.5 |
n.a. |
|
46 |
0.0142 |
0.0045 |
< 0.5 |
n.a. |
|
100 |
0.0308 |
0.0211 |
0.716 |
101 |
* Percentage of a saturated solution (SS) prepared at a loading rate of 100 mg/L.
# Absorbance of the samples is corrected for the mean of the blank i.e. 0.0097 AU (n=3).
n.d. Not detected.
n.a. Not applicable.
Table 2 Immobility observed during the final test
Time (h) |
Replicate |
INCA 460: MXDA Adduct Loading rate (mg/L) |
|||||
Control |
4.6 |
10 |
22 |
46 |
100 (0.71) |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
|
24 |
A |
0 |
0 |
0 |
0 |
0 |
1 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
2 |
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
0 |
3 |
|
Effect % |
0 |
0 |
0 |
0 |
0 |
15 |
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
0 |
2 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
3# |
|
D |
0 |
0 |
0 |
0 |
1 |
1 |
|
Total immobilised |
0 |
0 |
0 |
0 |
1 |
6 |
|
Effect % |
0 |
0 |
0 |
0 |
5 |
30 |
# Microscopic observation revealed no test item attached to the daphnids.
() – initially measured concentration (mg/L)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- 1). In the control, no daphnids became immobilised or showed other signs of disease or stress. 2). The oxygen concentration at the end of the test was ≥ 3 mg/L in control and test vessels (i.e., ≥ 8.5 mg/L).
- Conclusions:
- The 48h-EC50 for Daphnia magna exposed to INCA 460: MXDA Adduct exceeded the maximum solubility of the test item in test medium, i.e. exceeded a measured concentration of 0.71 mg/L.
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