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EC number: 202-190-2 | CAS number: 92-79-5
- 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
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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:
- 2017/03/02-2017/12/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-hydroxy-4'-methoxy-2-naphthanilide
- EC Number:
- 202-190-2
- EC Name:
- 3-hydroxy-4'-methoxy-2-naphthanilide
- Cas Number:
- 92-79-5
- Molecular formula:
- C18H15NO3
- IUPAC Name:
- 3-hydroxy-4'-methoxy-2-naphthanilide
- Test material form:
- solid
- Details on test material:
- - Batch number: 1283282001
- Purity: 98.8%
- Appearance/colour: solid/yellow-brown
- Expiry date: 30 April 2019
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 30.0, 10.0, 3.33, 1.11, 0.370 mg/L and control
- Sampling method: Analytical samples were taken in the main test at 0 hours (initial value) from fresh test solutions and after 24 hours, 48 hours and 72 hours from aged solutions from all test item loading rates and control. For each sampling also a retain sample was taken. Only the samples taken at 0h, fresh and after 72h, aged were analysed.
- Sample storage conditions before analysis: All samples were stored deep frozen until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solutions (S1, S2, S3) were prepared by directly weighing 30.0 mg in 1000 mL test medium, 10.0 mg in 1000 mL test medium and 6.66 mg in 2000 mL test medium. These stock solutions were stirred in the dark at room temperature for 24 h. Not the entire test item went into solution. Subsequently the undissolved test item was allowed to sediment and/or float for a period of 30 minutes until the phases had separated. After the settling the necessary volumes for the test were withdrawn via Teflon tubes from the medium level of the stock solutions. The test item solutions V1 – V2 were made by diluting stock solution S3 with test medium without algae to give the required loading rates.
- Test concentrations: 30.0, 10.0, 3.33, 1.11, 0.370 mg/L and control.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: SAG 61.81
- Source: commercial supplier
- Method of cultivation: The algae are grown semi-continuously in sterile cultures in the laboratory. Old medium is periodically replaced by fresh mineral solution in order to keep the algae in an exponential growth state. Stock cultures are ordered regularly from commercial supplier.
ACCLIMATION
- Acclimation period: 3 to 4 days
- Culturing media and conditions: same as the test; Illumination: continuously (approx. 4440 - 8880 lux at cell culture level or 60 – 120 µEm-2s-1); Temperature: 21 - 24 °C; Culture flasks: 100 mL Erlenmeyer flasks; CO2 supply by shaking on a rotating shaker, approximately 105 rpm
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 22.4 – 22.9 °C
- pH:
- pH of control: 7.40 – 7.47
pH of test: 7.34 - 7.62 - Nominal and measured concentrations:
- Nominal concentrations: 30.0, 10.0, 3.33, 1.11, 0.370 mg/L
Measured concentrations (based on the geometric mean of each concentration level): 3.84, 3.29, 0.549, 0.212 and 0.0625 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type: closed
- Material, size, headspace, fill volume: Erlenmeyer flasks (100 mL) with aluminium caps were filled up with ~ 50 mL test solution
- Renewal rate of test solution: no renewal
- Initial cells density: 5E+03 cells/mL
- Control end cells density: 3.954E+05 /mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, AAP-medium
OTHER TEST CONDITIONS
- Photoperiod: Continuously from the side
- Light intensity and quality: 88.8 µEm-2s-1
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: fluorescence microplate reader, determined in duplicate at 24, 48 and 72 hours
- Other: Measurements of pH-value were performed at t = 0 h and t = 72 h, the temperature was measured continuously and recorded at hours 0, 24, 48 and 72 hour. The light intensity of all positions of the incubator is measured once a year and was confirmed for one representative position at test start. Analytical samples of all test item loading rates and control were analysed at test start (0 hours fresh) and at test end (72 hours aged).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3
- Range finding study
- Test concentrations: Control, 100, 10.0, 1.00, 0.100 and 0.0100 mg/L
- Results used to determine the conditions for the definitive study: After 72 h at termination of the test no concentration response relation was observed for the inhibition of growth rate and yield. The inhibition of growth rate peaked in 9.5 % at a nominal loading rate of 0.0100 mg/L and the inhibition of yield peaked in 32.5 % at a nominal loading rate of 0.0100 mg/L. (see results in Results section) - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 3.84 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 3.84 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.84 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Biological Results: After 72 h at termination of the test no concentration response relation was observed for the inhibition of growth rate and yield. The inhibition of growth rate peaked in 1.2 % at a nominal loading rate of 0.370 mg/L and the inhibition of yield peaked in 5.3 % at a nominal loading rate of 0.370 mg/L. The cells were considered normal for the control and up to and including a test item loading rate of 30.0 mg/L.
- Analytical Results: The measured initial concentration of test item ranged from 15 % to 36 % of nominal. In the aged samples the measured content was between 11 % and 30 % of nominal. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: most recent test: yield 0.976 mg/L (nominal), growth rate 1.64 mg/L (nominal)
- Other: Significant inhibitory effects were determined for all parameters at test item concentrations of 0.800 mg/L and above.
Any other information on results incl. tables
Results non-GLP range finding test
loading rate (mg/L) | % inhibition at test end (72h) | |
growth rate | yield | |
Control | 0 | 0 |
0.010 | 9.5 | 32.5 |
0.100 | 4.3 | 16.1 |
1.0 | 5 | 19.3 |
10.0 | 3.2 | 8.6 |
100.0 | -2.7 | -10.8 |
Average cell number for each sampling time and loading rate:
Loading rate |
Average cell numbers [104/mL] |
|||
[mg/L] |
0 h |
24 h |
48 h |
72 h |
Control |
0.54 |
1.63 |
8.52 |
39.54 |
0.370 |
0.54 |
1.65 |
8.93 |
37.48 |
1.11 |
0.54 |
1.81 |
9.94 |
41.17 |
3.33 |
0.54 |
2.05 |
10.96 |
50.99 |
10.0 |
0.54 |
1.87 |
11.12 |
43.70 |
30.0 |
0.54 |
2.04 |
11.04 |
52.18 |
Percentage inhibition of growth rate:
Loading rate |
% Inhibition of growth rate |
||
[mg/L] |
0 h–24h |
0h–48h |
0h–72h |
Control |
0.0 |
0.0 |
0.0 |
0.370 |
-0.8 |
-1.7 |
1.2 |
1.11 |
-8.5 |
-5.5 |
-1.0 |
3.33 |
-20.6 |
-9.1 |
-6.0 |
10.0 |
-12.0 |
-9.5 |
-2.3 |
30.0 |
-20.1 |
-9.3 |
-6.5 |
Toxicological endpoints for the test item:
Test item [mg/L] | ||
Loading rate | Measured Concentration | |
ErL10, ErC10(Growth rate) | > 30.0 | > 3.84 |
ErL20, ErC20 | > 30.0 | > 3.84 |
ErL50, ErC50 | > 30.0 | > 3.84 |
EyL10, EyC10(Yield) | > 30.0 | > 3.84 |
EyL20, EyC20 | > 30.0 | > 3.84 |
EyL50, EyC50 | > 30.0 | > 3.84 |
NOELR, NOEC | 30 | 3.84 |
LOELR, LOEC | - | - |
Determined concentration of Test item:
Test item nominal concentration (loading rate) [mg/L] | Sampling | Test item measured concentration[mg/L] | % of nominal concentration | Geometric mean [%] | Geometric mean concentration [mg/L] |
Control | 0 h fresh | n.d. | - | - | - |
72 h aged | n.d. | - | |||
0.37 | 0 h fresh | 0.0805 | 22 | 16.9 | 0.0625 |
72 h aged | 0.0477 | 13 | |||
1.11 | 0 h fresh | 0.308 | 28 | 19.1 | 0.212 |
72 h aged | 0.145 | 13 | |||
3.33 | 0 h fresh | 0.7 | 21 | 16.5 | 0.549 |
72 h aged | 0.433 | 13 | |||
10 | 0 h fresh | 3.59 | 36 | 32.9 | 3.29 |
72 h aged | 2.99 | 30 | |||
30 | 0 h fresh | 4.37 | 15 | 12.8 | 3.84 |
72 h aged | 3.35 | 11 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- No statistically significant inhibitory effects on any parameter (growth rate, yield) were observed at any of the test item loading rates, including the highest test item loading rate of 30.0 mg/L (nominal) equal to 3.84 mg/L (measured concentration) at test end. Thus the overall LOELR and LOEC were not determinable, the overall NOELR was observed to be at 30.0 mg/L (nominal) and the corresponding overall NOEC was determined as 3.84 mg/L (measured).
The EL10-, EL20- and EL50-value for growth rate (ErL10, 20, 50) and the EL10-, EL20- and EL50-value for yield (EyL10, 20, 50) were > 30.0 mg/L (nominal). The EC10-, EC20- and EC50-value for growth rate (ErC10, 20, 50) and the EC10-, EC20- and EC50-value for yield (EyC10, 20, 50) were > 3.84 mg/L (measured). - Executive summary:
The effects of test item on the growth of the single cell green alga Pseudokirchneriella subcapitata were determined according to OECD Guideline 201.
A static test with nominal loading rates of 30.0, 10.0, 3.33, 1.11, 0.370 mg/Land control was performed. Six replicates were employed for the control and three for each test item concentration. Initial cell densities of 5 E+03 cells/mL were employed for the individual replicates. The increase of cell numbers was assessed over a test period of 72 hours.
Samples from control and all test item loading rates at 0 hours (initial value) from fresh test solutions and after 72 hours from aged solutions were analysed. The measured initial concentration of test item ranged from15% to 36% of nominal. In the aged samples the measured content was between 11% and 30% of nominal. The geometric mean measured concentrations were found to be: 0, 0.0625, 0.212, 0.549, 3.29 and 3.84 mg/L.
No statistically significant inhibitory effects on any parameter (growth rate, yield) were observed at any of the test item loading rates, including the highest test item loading rate of 30.0 mg/L (nominal) and 3.84 mg/L (measured concentration) at test end. Thus the overall LOELR and LOEC were not determinable, the overall NOELR was observed to be at 30.0 mg/L (nominal) and the corresponding overall NOEC was determined as 3.84 mg/L (measured).
The EL10-, EL20- and EL50-value for growth rate (ErL10, 20, 50) and the EL10-, EL20- and EL50-value for yield (EyL10, 20, 50) were > 30.0 mg/L (nominal). The EC10-, EC20- and EC50-value for growth rate (ErC10, 20, 50) and the EC10-, EC20- and EC50-value for yield (EyC10, 20, 50) were > 3.84 mg/L (measured).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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