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EC number: 229-104-6 | CAS number: 6410-38-4
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-01-08 to 2010-01-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study meets requirements of OECD Guideline 211 and GLP requirements with no deviations.
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 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide
- EC Number:
- 229-440-3
- EC Name:
- 3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide
- Cas Number:
- 6535-46-2
- Molecular formula:
- C24H16Cl3N3O2
- IUPAC Name:
- 3-hydroxy-N-(2-methylphenyl)-4-[(2,4,5-trichlorophenyl)diazenyl]-2-naphthamide
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Name of test material (as cited in study report): (no report title): Pigment Red 112
Analytical purity: 99.8 %
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
- Details on sampling:
- No analytical determination of the test item was carried out due to the low water solubility of the test item.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A saturated solution* was prepared. A dispersion of 1 mg/L prepared in dilution water was shaken with 20 rpm for 48 h at ambient temperature and filtrated with 0.45 µm RC filter.
- Eluate: Dilution water
- Differential loading: The saturated solution was tested as limit concentration.
- Controls: Six replicates without test item were tested under the same test conditions as the test replicates.
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmus subspicatus Chodat
- Strain: SAG 86.81
- Source (laboratory, culture collection): SAG Pflanzenphysiologisches Institut der Universitaet Goettingen, Nikolausberger Weg 18, D-37073 Goettingen, Germany
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Fresh stocks were prepared from Z-Agar. Light intensity amounted 35 - 70 µE x m-2 x s-1 for 24 h per day.
ACCLIMATION
- Culturing media and conditions (same as test or not): Same as test
- Any deformed or abnormal cells observed: No
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- The test medium had a nominal hardness of 0.24 mmol CaMg/L
- Test temperature:
- Mean: 21.5 °C, Min: 21 °C, Max: 22 °C
- pH:
- Nominal test item concentration pH-value
[mg/L] Start; 0 h End; 72 h
Saturated solution (1 mg/L) 8.04 8.35
Control 8.13 8.34 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- See above
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: sterile 250 mL Erlenmeyer flasks, test volume 100 mL
- Aeration: Test containers were placed on a rotary shaker and oscillated at appr. 70 rpm
- Type of flow-through (e.g. peristaltic or proportional diluter): None
- Renewal rate of test solution (frequency/flow rate): One application at test start
- Initial cells density: 5074 cells/mL
- Control end cells density: Mean 636336 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): None
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water, composition acc. to the guideline
- Hardness: 0.24 mmol Ca+Mg/L
- pH-value: 8.1 +/- 0.2
- Culture medium: Nutrient Medium Z acc. to LÜTTGE et al. (1994)
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: 60 - 120 µE x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter] Fluorimeter, via Chlorophyll-a fluorescence (excitation at 436 nm, emission at 685 nm), cell concentrations were related to all cell density values acc. to a calibration curve.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: None, limit test
- Range finding study:
Results of the Range Finding Test (0-72 h)
Saturated solution [mg/L] Specific Growth Rate Inhibition [%] Yield Inhibition [%]
Filtration of the saturated solution
20 - 3 - 19
1 - 3 - 19
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 other: mg/L (saturated solution)
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test):
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50:
Rate-related inhibition: 0.60 (CI 0.545 - 0.653) mg/L
Yield Inhibition: 0.28 (CI 0.266 - 0.299) mg/L - Reported statistics and error estimates:
- The NOEC and LOEC were determined by calculation of
statistical analyses statistical significance of growth rates and yield.
t-test was carried out for the determination of statistically significant differences compared to control replicates. When running a t-test a Normality Test and an Equal Variance Test were done first. P-values for both Normality and Equal Variance Tests were 0.05. The a-value was a=0.05. Detection of statistically significant differences were considered negligible when inhibition values were ≤ 10 %. These findings were marked biological not significant.
Any other information on results incl. tables
NOEC, LOEC and EC - values and 95 % Confidence Intervals of the test item (0-72 h)
based on nominal test item concentration [mg/L]
Rate-related Inhibition |
|
NOEC |
Saturated solution (1 mg/L) |
LOEC |
> Saturated solution (1 mg/L) |
ErC10 |
> Saturated solution (1 mg/L) |
ErC20 |
> Saturated solution (1 mg/L) |
ErC50 |
> Saturated solution (1 mg/L) |
Inhibition of Yield |
|
NOEC |
Saturated solution (1 mg/L) |
LOEC |
> Saturated solution (1 mg/L) |
EyC10 |
> Saturated solution (1 mg/L) |
EyC20 |
> Saturated solution (1 mg/L) |
EyC50 |
> Saturated solution (1 mg/L) |
Cell Densities
|
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
||||||
[mg/L] |
No. |
0 h |
24 h |
48 h |
72 h |
|
|||
Saturated solution (1 mg/L) |
1 |
5074 |
19924 |
172088 |
811286 |
|
|||
2 |
5074 |
22729 |
170534 |
778264 |
|
||||
3 |
5074 |
24729 |
147336 |
721561 |
|
||||
4 |
5074 |
22023 |
140071 |
772979 |
|
||||
5 |
5074 |
23323 |
172006 |
761032 |
|
||||
6 |
5074 |
21941 |
177028 |
809346 |
|
||||
Mean |
5074 |
22445 |
163177 |
775745 |
|
||||
Control |
1 |
5074 |
22589 |
146618 |
743013 |
|
|||
2 |
5074 |
22778 |
126409 |
607983 |
|
||||
3 |
5074 |
21527 |
162481 |
677384 |
|
||||
4 |
5074 |
19227 |
151563 |
600533 |
|
||||
5 |
5074 |
25234 |
125864 |
562982 |
|
||||
6 |
5074 |
23782 |
161637 |
626122 |
|
||||
Mean |
5074 |
22523 |
145762 |
636336 |
|
Evaluation after 72 h
Statistically significant differences of growth rates and yield compared to
control values are marked (+), not significant differences are marked (-).
Nominal test item concentration |
Replicate |
Growth rate |
Rate-related inhibition |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
Saturated solution (1 mg/L) |
1 |
1.69 |
-5.12 |
806212 |
-27.7 |
||
2 |
1.68 |
-4.26 |
773190 |
-22.5 |
|||
3 |
1.65 |
-2.69 |
716487 |
-13.5 |
|||
4 |
1.68 |
-4.11 |
767905 |
-21.7 |
|||
5 |
1.67 |
-3.79 |
755958 |
-19.8 |
|||
6 |
1.69 |
-5.07 |
804272 |
-27.4 |
|||
Mean |
(+)* |
1.68 |
-4.17 |
(+)* |
770671 |
-22.1 |
|
Control |
1 |
1.66 |
737939 |
||||
2 |
1.60 |
602909 |
|||||
3 |
1.63 |
672310 |
|||||
4 |
1.59 |
595459 |
|||||
5 |
1.57 |
557908 |
|||||
6 |
1.61 |
621048 |
|||||
Mean |
1.61 |
631262 |
Section-by-Section and Average
Specific Growth Rates of the Control Group
(0 – 72 h)
Replicate No. |
Specific growth rate [d-1] |
Mean (0 - 72 h) |
SD ± |
CV |
Mean CV [%] |
|||
section-by-section |
||||||||
0 - 24 h |
24 - 48 h |
48 - 72 h |
||||||
Control |
1 |
1.49 |
1.87 |
1.62 |
1.66 |
0.192 |
11.5 |
14.4 |
2 |
1.50 |
1.71 |
1.57 |
1.60 |
0.108 |
6.78 |
||
3 |
1.45 |
2.02 |
1.43 |
1.63 |
0.338 |
20.7 |
||
4 |
1.33 |
2.07 |
1.38 |
1.59 |
0.411 |
25.8 |
||
5 |
1.60 |
1.61 |
1.50 |
1.57 |
0.062 |
3.95 |
||
6 |
1.55 |
1.92 |
1.35 |
1.61 |
0.286 |
17.8 |
||
Mean |
1.61 |
|
||||||
± SD |
0.03 |
|
||||||
CV [%] |
2.04 |
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study the test item was found not to inhibit the freshwater green algae Desmodesmus subspicatus after 72 h at the saturated solution (prepared with 1 mg/L). All effect levels are given based on the nominal concentration of Pigment Red 112.
- Executive summary:
The toxicity of Pigment Red 112 (batch number 2468) to the unicellular freshwater green algae Desmodesmus subspicatus was determined according to the principles of OECD 201 at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany from January 08 to 14, 2010 with the definitive exposure phase from January 11 to 14, 2010. The aim of the study was to assess the effects on growth rate and yield over a period of 72 h.
The study was conducted under static conditions with an initial cell density of approximately 2 – 5 x 103cells/mL. Based on a preliminary range finding test, a limit test with a saturated solution* was carried out. The saturated solution was prepared out of the dispersion of 1 mg/L. Six replicates were tested for the limit concentration and control. Environmental conditions were determined to be within the acceptable limits.
All effect values are given based on the nominal concentration of the test item.
NOEC, LOEC and EC - values and 95 % Confidence Intervals of the tets item (0-72 h)
based on nominal test item concentration [mg/L]
Rate-related Inhibition
NOEC
Saturated solution (1 mg/L)
LOEC
> Saturated solution (1 mg/L)
ErC10
> Saturated solution (1 mg/L)
ErC20
> Saturated solution (1 mg/L)
ErC50
> Saturated solution (1 mg/L)
Inhibition of Yield
NOEC
Saturated solution (1 mg/L)
LOEC
> Saturated solution (1 mg/L)
EyC10
> Saturated solution (1 mg/L)
EyC20
> Saturated solution (1 mg/L)
EyC50
> Saturated solution (1 mg/L)
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