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EC number: 210-038-1 | CAS number: 603-40-7
- 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:
- From 16th to 18th February 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 13th 2004 version
- Deviations:
- yes
- Remarks:
- According to the study report, test vessels were aerated during the test.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-benzylidenedianiline
- EC Number:
- 210-038-1
- EC Name:
- 4,4'-benzylidenedianiline
- Cas Number:
- 603-40-7
- Molecular formula:
- C19H18N2
- IUPAC Name:
- 4-[(4-aminophenyl)(phenyl)methyl]aniline
- Test material form:
- solid
- Details on test material:
- Identification: DATIPH
Physical form: Solid
Solubility in water: < 1 g/L
Colour: yellow brown
CAS no.: 603-40-7
Chemical name: 4,4’-Benzylidenedianiline
Molecular formula: C19H18N2
Test substance storage: At room temperature protected from light
Stability: Stable under storage conditions
Expiry date: 31 October 2010
Constituent 1
- Specific details on test material used for the study:
- Identification: DATIPH
Chemical name: 4,4’-Benzylidenedianiline
Physical form: solid
Colour: yellow brown
Solubility in water: <1 g/l (virtually insoluble)
CAS no.: 603-40-7
EINECS no.: 210-038-1
Molecular formula: C19H18N2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The water accommodated fractions of DATIPH were prepared by adding the respective amounts of an acetonic stock solution to the empty test vessels. After complete evaporation of the solvent, the Daphnia medium was applied. The test solutions were moderately stirred overnight followed by filtration (glass fibre filter). The resulting water accommodated fractions were used in the test.
About 2 h before the test, the vessels were filled with the formulated media to allow equilibration of pH, oxygen and temperature.
Test solutions
- Vehicle:
- yes
- Remarks:
- The vehicle is the formulated Daphnia medium (see water media type)
- Details on test solutions:
- Based on the data of a non-GLP range finding test using water accommodated fractions of DATIPH a definitive test with nominal concentration of DATIPH of 6.4, 16, 40, 100, and 250 mg/l was performed.
A spacing factor greater than the recommended maximum factor of 2.2 was selected because of the unusually flat concentration-response curve (presumably due to the limited water solubility).
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test organism: Daphnia magna (Straus, 1820)
Breeding: Parental and young Daphnia will be held in 40 I glass aquaria at 20 ± 2 °C.
Illumination: 16 h per day
Medium: Continuously aerated Elendt M4 medium (Tables 1 and 2); prepared with deionised water (conductivity <1.5 ¿/S/cm).
Feed: 15 g sera micropan (sera GmbH, D-52525 Heinsberg) homogenized in 1 I deionised water
Frequency of feeding: Once a day, except weekends.
Control of sensitivity: Periodically conducted acute reference test with potassium dichromate.
Study design
- Test type:
- static
- Water media type:
- other: Elendt M4 medium
- Remarks:
- Separate stock solutions (I) of trace elements are first prepared in deionised water. From these different stock solutions (I) a second single stock solution (II) is prepared, which contains all trace elements (combined solution, see tables given below).
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Daphnia were acclimatised to the medium for about 2 h before introduction into the test media.
- Post exposure observation period:
- Not relevant.
Test conditions
- Hardness:
- As given by the composition of the prepared Elendt M4 medium.
- Test temperature:
- 20 ±2 °C.
- pH:
- Between 7.1 and 7.9.
- Dissolved oxygen:
- Between 5.9 and 6.8 mg/L.
- Salinity:
- As given by the composition of the prepared Elendt M4 medium.
- Conductivity:
- < 1.5 µS/cm.
- Nominal and measured concentrations:
- Nominal concentrations (mg/L) Measured concentrations (mg/L)
6.4 2.22
6.4 2.22
16 3.07
16 3.03
40 5.00
40 5.00
100 5.50
100 5.53
250 11.8
250 11.9 - Details on test conditions:
- Test vessel: 100 ml flasks, all-glass, with 50 ml of test medium
Test medium: Continuously aerated Elendt M4 medium (Tables 1 and 2); prepared with deionised water (conductivity <1.5/uS/cm)
Number of Daphnia: 40 individuals per test concentration, 20 per vessel
Size: <2 mm
Light: 16 h photoperiod a day, supplied by overhead white fluorescent tubes
Temperature: 20 ±2 °C (temperature-controlled room)
Test type: Static exposure conditions
Test duration: 48 hours
Daphnia, which were selected in size, were acclimatised to the medium for about 2 h before introduction into the test media. The pH was adjusted before the test, if necessary.
For each test series the following number of test flasks was set up:
• Test suspension (Tn); containing test medium, test substance, two replicate samples with 20 Daphnia each;
• Blank control (Bn); containing test medium, three replicate samples with 20 Daphnia each. - Reference substance (positive control):
- yes
- Remarks:
- Periodically conducted acute reference test with potassium dichromate.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 11.7 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Measured concentrations in tested substance
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 6.76 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Measured concentrations in tested substance
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % confidence limits for EC50 (mg/l): 5.75 - 8.32
- Duration:
- 24 h
- Dose descriptor:
- EC0
- Effect conc.:
- ca. 5.26 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Measured concentrations in tested substance
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 11.7 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Measured concentrations in tested substance
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- ca. 2.27 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Measured concentrations in tested substance
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 12.4 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Measured concentrations in tested substance
- Basis for effect:
- mobility
- Details on results:
- EFFECTS ON MOBILITY:
After 24 h of incubation the following percentage of immobilization of the total of 40 individuals was observed at the respective nominal concentrations:
250 mg/l (45%). No significant effects (≤ 10% of a total of 40 individuals) were observed at 100, 16 and 6.4 mg/l and in the blank control. The 15% immobilization observed at 40 mg/l were considered to be an outlier.
After 48 h of incubation the following percentage of immobilization of the total of 40 individuals was observed at the respective nominal concentrations: 250 mg/l (82.5%), 100 mg/l (45%), 40 mg/l (25%), 16 mg/l (15%). No significant effects (≤ 10% of a total of 40 individuals) were observed at 6.4 mg/l and in the blank control. Immobilization at 48 h was increased as compared to the effects after 24 h.
DETERMINATION OF EC50, EC0 AND EC100:
Based on the immobilization data the median effect concentration (EC50) of DATIPH to Daphnia magna for 24 h was estimated to be >11.7 mg/l with respect to the time- weighted average of the measured concentrations. The 48 h EC50 was calculated to be 6.76 mg/l (95% confidence limits: 5.75 - 8.32 mg/l).
The experimentally determined no-effect concentration (NOEC, EC0) was 5.50 and 2.27 mg/l with respect to the time-weighted average of the measured concentrations after an exposure of 24 and 48 h.
100% immobility (EC10o) was not observed
The calculated or estimated data for EC0 and EC100 were:
EC0 for 24 h: 5.26 mg/l
EC100 for 24 h: >11.7 mg/l
EC0 for 48 h: 2.27mg/l
EC100 for 48 h: >12.4 mg/l
The coefficients (r^2) of the regression curves for the 24 and 48 h observations were 0.970 and 0.920, respectively. - Results with reference substance (positive control):
- Not reported.
- Reported statistics and error estimates:
- 95 % confidence limits for EC50 (mg/l): 5.75 - 8.32.
Any other information on results incl. tables
Table 1: Immobilisation of Daphnia magna after 24 and 48 hours of exposure to the test material
Nominal concentration (mg/l) |
Code |
Number of individuals per test vessel |
ImmobileDaphnia(No./vessel) 24 h |
ImmobileDaphnia(No./vessel) 48 h |
% immobileDaphniaafter 24 h of exposure |
% immobileDaphniaafter 48 h of exposure |
Control |
A |
20 |
0 |
1 |
0 |
5 |
0 |
B |
20 |
0 |
0 |
0 |
0 |
|
C |
20 |
0 |
0 |
0 |
0 |
6.4 |
A |
20 |
1 |
1 |
5 |
5 |
|
B |
20 |
1 |
1 |
5 |
5 |
16 |
A |
20 |
0 |
4 |
0 |
20 |
|
B |
20 |
0 |
2 |
0 |
10 |
40 |
A |
20 |
1 |
4 |
5 |
20 |
|
B |
20 |
5 |
6 |
25 |
30 |
100 |
A |
20 |
1 |
8 |
5 |
40 |
|
B |
20 |
0 |
10 |
0 |
50 |
250 |
A |
20 |
8 |
17 |
40 |
85 |
|
B |
20 |
10 |
16 |
50 |
80 |
Table 2: pH and oxygen values concentrations at the start and at the end of the test
Nominal concentration (mg/l) |
Code |
pH-values 0h |
pH-values 48h |
Oxygen concentration (mg/l),0h |
Oxygen concentration (mg/l), 48 h |
0 (control) |
A B C |
7.3 |
7.8 |
6.3 |
6.8 |
6.4 |
A B |
7.3 |
7.8 |
6.0 |
6.4 |
16 |
A B |
7.2 |
7.9 |
6.0 |
6.3 |
40 |
A B |
7.1 |
7.8 |
6.1 |
6.0 |
100 |
A B |
7.1 |
7.9 |
6.1 |
6.3 |
250 |
A B |
7.1 |
7.9 |
5.9 |
6.0 |
Table 3: Analytically determined concentrations in the definitive test
Nominal concentration (mg/L) | Code | Test concentrations determined at different points in time after start of exposure (mg/L) |
||||
Time (hours) | TWA | |||||
0 | 24 | 48 | 24 hours | 48 hours | ||
6.4 | A B |
2.22 2.22 |
2.16 2.13 |
2.31 2.34 |
2.16 2.13 |
2.26 2.27 |
16 | A B |
3.07 3.03 |
3.00 3.01 |
3.19 3.23 |
3.00 3.01 |
3.13 3.16 |
40 | A B |
5.00 5.00 |
4.96 4.94 |
5.31 5.20 |
4.96 4.94 |
5.19 5.11 |
100 | A B |
5.50 5.53 |
5.55 5.45 |
5.93 5.81 |
5.55 5.45 |
5.80 5.69 |
2.5 | A B |
11.8 11.9 |
11.7 11.8 |
12.7 12.7 |
11.7 11.8 |
12.3 12.4 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Not more than 10% of the Daphnia in the control have been immobilized or trapped at the surface of the water. The dissolved oxygen concentration at the end of the test was >3 mg O2/l.
- Conclusions:
- Based on the immobilization data, the median effect concentration (EC50) of DATIPH to Daphnia magna for 24 h was estimated to be >11.7 mg/l with respect to the time-weighted average of the measured concentrations. The 48 h EC50 was calculated to be 6.76 mg/l (95% confidence limits: 5.75 - 8.32 mg/l).
- Executive summary:
The median effective concentration (EC50) of DATIPH (4,4'-Benzylidenedianiline) to Daphnia magna was investigated under static exposure conditions over a period of 48 h.
40 individual Daphnia divided in 2 test vessels were exposed to each concentration of the test substance.
The nominal concentrations of DATIPH, as selected by a preceding non-GLP range finding test, were 6.4, 16, 40, 100 and 250 mg/l, respectively.
Due to the limited water solubility of the test material, only the water accommodated fractions of DATIPH were tested.
After 24 h of incubation the following percentage of immobilization of the total of 40 individuals was observed at the respective nominal concentrations:
250 mg/l (45%). No significant effects (≤ 10% of a total of 40 individuals) were observed at 100, 16 and 6.4 mg/l and in the blank control. The 15% immobilization observed at 40 mg/l were considered to be an outlier.
After 48 h of incubation the following percentage of immobilization of the total of 40 individuals was observed at the respective nominal concentrations:
250 mg/l (82.5%), 100 mg/l (45%), 40 mg/l (25%), 16 mg/l (15%). No significant effects (<10% of a total of 40 individuals) were observed at 6.4 mg/l and in the blank control. Immobilization at 48 h was increased as compared to the effects after 24 h.
Based on the immobilization data the median effect concentration (EC50) of DATIPH to Daphnia magna for 24 h was estimated to be >11.7 mg/l with respect to the time-weighted average of the measured concentrations. The 48 h EC50was calculated to be 6.76 mg/l (95% confidence limits: 5.75 - 8.32 mg/l).
The experimentally determined no-effect concentration (NOEC, EC0) was 5.50 and 2.27 mg/l with respect to the time-weighted average of the measured concentrations after an exposure of 24 and 48 h.
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