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EC number: 268-028-8 | CAS number: 67990-05-0
- Life Cycle description
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- 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
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- Specific investigations
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- Additional toxicological data
Sediment toxicity
Administrative data
Link to relevant study record(s)
- Endpoint:
- sediment toxicity: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-26 to 2008-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study compliant to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment (October 2007)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP according to German Chemikaliengesetz and Directive 88/320/EEC
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on sediment and application:
- PREPARATION OF SPIKED SEDIMENT
- Details of spiking: The test substance concentration was weighed out, dissolved in 15 mL acetone and mixed thoroughly with 60 g quartz sand (10 g quartz sand per replicate) in a glass vessel. After complete evaporation of the solvent, the dry quartz sand was given to the sediment. Residues of the dry quartz sand sticking at the glas vessel were rinsed off with 50 mL demineralised water per treatment. Thereafter, the sediment was thoroughly mixed with a long handled blender for at least three minutes and filled into the test vessels.
- Equilibration time: 2 days prior to insertion of test organisms
- Equilibration conditions: Same as test
- Controls: Controls with test sediment and quartz sand. Vehicle controls with test sediment and quartz sand treated with acetone.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): organic solvent, acetone
- Concentration of vehicle in test medium (stock solution and final test solution): 15 mL per 60 g quartz sand (6 replicates)
- Evaporation of vehicle before use: Yes, complete evaporation
- Test organisms (species):
- Lumbriculus variegatus
- Details on test organisms:
- TEST ORGANISM
- Common name: Lumbriculus variegatus (Müller), Lumbriculidae, Oligochaeta
- Source: Bundesanstalt für Gewässerkunde (BfG), Am Mainzer Tor 1, 56068 Koblenz, Germany
- Age of test organisms (mean and range, SD): Synchronized from cultured organisms 13 days before test insertion
- Breeding conditions: 20 +/- 2 deg C, diffuse light (100 - 1000 lx, 16 h photoperiod) dissolved oxygen concentration > 60 % of the air saturation value
- Handling of worms: 13 days before insertion into the test, the worms were synchronized. Therefore, a sufficient amount of worms was taken from the breeding and cut into half.. After regeneration of heads, the worms were inserted into the test.
- Age of animals at beginning of exposure: 13 days after synchronisation, completely regenerated head region. Synchronization was done to minimize uncontrolled regeneration and reproduction during the test.
- Feeding during test
- Food type: Powder of Urtica dioica (Heinrich Klein GmbH & Co KG, 97525 Schwebheim, Germany)
- Amount: 0.5 % Urtica powder
- Frequency: Urtica powder was mixed into the sediment once at test start.
ACCLIMATION
- Acclimation period: 13 days (after synchronization)
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Same as test
- Feeding frequency: Same as test (Once)
- Health during acclimation (any mortality observed): No mortality observed - Study type:
- laboratory study
- Test type:
- static
- Water media type:
- freshwater
- Type of sediment:
- artificial sediment
- Limit test:
- yes
- Duration:
- 28 d
- Exposure phase:
- total exposure duration
- Hardness:
- Day 0: Control: > 356 mg/L CaCO3, Solvent Control: 340 mg/L CaCO3, 1000 mg test substance/kg sediment DW: > 356 mg/L CaCO3
Day 28: Control: > 356 mg/L CaCO3, Solvent Control: > 356 mg/L CaCO3, 1000 mg test substance/kg sediment DW: > 356 mg/L CaCO3 - Test temperature:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 Temperature [°C] 21.1 21.0 20.9
7 Temperature [°C] 21.9 21.2 21.9
14 Temperature [°C] 22.0 20.2 20.2
21 Temperature [°C] 21.8 21.8 21.4
28 Temperature [°C] 21.8 21.2 20.8 - pH:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 pH 7.74 7.82 7.88
7
pH 7.86 7.86 7.88
14
pH 7.76 7.79 7.86
21
pH 7.58 7.87 8.01
28
pH 8.22 8.27 8.29 - Dissolved oxygen:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 O2 [mg/L] 6.16 6.78 6.37
7 O2 [mg/L] 6.06 6.05 6.40
14 O2 [mg/L] 6.90 6.22 6.71
21 O2 [mg/L] 7.37 7.11 7.05
28
O2 [mg/L] 7.30 8.04 7.96 - Salinity:
- Not measured, freshwater conditions
- Ammonia:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 NH4-N [mg/L] 0.803 0.622 0.797
2 NH4-N [mg/L] 0.114 < 0.02* < 0.02*
5 NH4-N [mg/L] 0.039 0.031 0.113
8 NH4-N [mg/L] 0.045 0.039 0.044
9 NH4-N [mg/L] 0.091 0.050 0.031
12 NH4-N [mg/L] 0.064 0.060 0.068
15 NH4-N [mg/L] 0.089 0.241 0.063
16 NH4-N [mg/L] 1.03 0.715 0.121
19 NH4-N [mg/L] > 2.5* > 2.5* > 2.5*
NH4-N [mg/L] 5.71 5.35 4.29
23 NH4-N [mg/L] 4.84 4.75 5.42
26 NH4-N [mg/L] 6.91 6.01 5.85
28 NH4-N [mg/L] 6.76 6.58 4.30
- Nominal and measured concentrations:
- ominal concentration limit concentration: 1000 mg test substance/kg sediment DW.
The submission substance has a low water solubility and due to its sorption to particular matter, low volatility and very low biotic and abiotic degradation. It resides predominantly in the solid phase of the sediment. The fraction of the pigment in the overlying water as well as the porewater can be neglected. As no loss of pigment was expected to occur during the exposure period an analytical determination of the pigment in the overlying water and the sediment has been omitted. Based on the fact that the test system consists of 150 mL overlying water 0.008 % pigment would be in the overlying water at saturation and thus 99.992 % remains in the sediment (solids & porewater). - Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 250 mL glass beakers, 6 cm diameter
- Sediment volume: 45 g DW per vessel, ca. 2 cm from the ground
- Overlying water volume: 150 mL
- Depth of sediment and overlying water: Sediment depth ca. 2 cm, water depth ca. 10 cm
- Aeration: yes
- Aeration frequency and intensity: Gentle aeration (2 bubbles per second)
- Replacement of evaporated test water, if any: Yes, once weekly
EXPOSURE REGIME
- No. of organisms per container (treatment): 10 per container (60 per treatment)
- No. of replicates per treatment group: 6 replicates per treatment group
- No. of replicates per control / vehicle control: 6 replicates per control/vehicle control
- Feeding regime: Once at test start
- Type and preparation of food: Powder of Urtica dioica mixed into the sediment before insertion of test organisms
- Amount of food: 0.5 %
OVERLYING WATER CHARACTERISTCS
- Type of water (e.g. deionized, ground water, sea water, Elendt medium acc. to OECD 219): Reconstituted water acc. to OECD 203
CHARACTERIZATION OF (ARTIFICIAL; delete if not applicable) SEDIMENT
- Composition (if artificial substrate): 5 % peat air dried and finely ground, 20 % kaolin, 75 % quartz sand, 0.33 % calcium carbonate
Table 1: Sediment Properties at Test Start
Total Organic Carbon [%] pH-value Moisture [%]
Sediment at test start 2.15 6.74 8.29
OTHER TEST CONDITIONS
Room temperature [°C] Photoperiod [h] Light intensity [lx]
Nominal 20 +/- 2 16 100 - 1000
Actual 18 - 21 16 472 +/- 47.2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behaviour changes (Day 0-28), reproduction and biomass at test end (28 d)
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
1000 mg test substance/kg sediment DW
- Range finding study
- Test concentrations: 10 - 100 - 1000 mg/kg sediment DW
- Results used to determine the conditions for the definitive study:
Concentration Mortality Mean number of worms Mean dry weight
[mg test item/kg sediment DW] [%] [mg]
Control 0 13.5 14.7
Solv. Control 0 14.5 16.0
10 0 13.0 35.4
100 0 11.5 16.8
1000 0 12.0 15.9 - Reference substance (positive control):
- no
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg sediment dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality, behaviour, biomass reproduction
- Details on results:
- - Mortality of test animals at end of exposure period: No mortality
- Total mass of test animals at beginning of test: 10 worms were equal to ca. 45.8 mg wet mass
- Morphological abnormalities: None
- Behavioural abnormalities: None - Reported statistics and error estimates:
- One Way Analysis of Variance (ANOVA, Dunnett´s Method) was carried out with worm numbers and biomass data for the determination of statistically significant differences compared to the pooled control. Prior to the ANOVA a normality test and an equal variance test were conducted. P-values for both normality and equal variance test were 0.05. The alpha-value (acceptable probability of incorrectly concluding that there is a difference) for ANOVA was alpha = 0.05.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this sedmient-water Lubriculus toxicity test according to OECD 225 the submission substance caused no significant effects on mortality, behaviour, biomass and reproduction at the limit test item concentration of 1000 mg/kg sediment DW. Thus, the NOEC was determined to be equal or larger than 1000 mg/kg sediment DW.
- Executive summary:
The effects of the test item on the oligochaete Lumbriculus variegatus in a water-sediment system were determined. The study was carried out according to OECD Guideline 225 (2007) compliant to GLP (reliability category 1). Test duration was 28 days after insertion of the test organisms. A limit test with the nominal test concentration of 1000 mg/kg sediment dry weight (DW) was performed by spiking the test item into the sediment. Six replicates per control, vehicle control and limit test item concentration with ten worms per replicate were set up. Water quality parameters as temperature, pH-value, O2-concentration, ammonia and total hardness were determined.
Due to the chemical properties of the test item the fraction of the pigment in the overlying water
as well as in the porewater can be neglected. Thus, no analytical verification of the test item
was performed.
After 28 days no mortality or significant behavioural changes of L. variegatus were observed at the limit test item concentration of 1000 mg/kg sediment DW. Also, the biomass was not significantly reduced compared to the pooled control after 28 days of exposure to the test item. L. variegatus reproduced without any significant differences between the pooled control and the limit test item concentration of 1000 mg/kg sediment DW (Table 1).
Table 1: Summary of all Significant Effects
Effects
Test item concentration
Significance of effects
[mg/kg sediment DW]
Mortality
> 1000
Behaviour
> 1000
Biomass
> 1000
Reproduction
> 1000
NOEC
(mortality, behaviour, biomass, reproduction)
>= 1000
- Endpoint:
- sediment toxicity: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-26 to 2008-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study compliant to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 225 (October 2007) Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- According to German Chemikaliengesetzt and Directive 88/320/EEC
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on sediment and application:
- PREPARATION OF SPIKED SEDIMENT
- Pooling or mixing of different substrates: Test sediment was artificial soil acc. to OECD 207, modified, consisting of 5 % peat, 20 % kaolin, 75 % quartz sand and 0.33 % calcium carbonate
- Details of spiking: The test substance concentration was weighed out, dissolved in 15 mL acetone and mixed thoroughly with 60 g quartz sand (10 g per replicate). After complete evaporation of the solvent, the dry quartz sand was given to the sediment. Residues of the dry quartz sand sticking at the glass vessel were rinsed off with 50 mL demineralised water per treatment. Thereafter, the sediment was thoroughly mixed with a long handled blender for at least three minutes and filled into the test vessels.
- Equilibration time: Two days before insertion of the test organisms
- Equilibration conditions: Same as test
- Controls: Controls with test sediment and quartz sand. Vehicle controls with test sediment and quartz sand treated with acetone
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Organic solvent, acetone
- Concentration of vehicle in test medium (stock solution and final test solution): 15 mL acetone per 6 replicates
- Evaporation of vehicle before use: Yes completely evaporated
- Test organisms (species):
- Lumbriculus variegatus
- Details on test organisms:
- TEST ORGANISM
- Common name: Lumbriculus variegatus (Müller), Lumbriculidae, Oligochaeta
- Source: Bundesanstalt für Gewässerkunde (BfG), Am Mainzer Tor 1, 56068 Koblenz, Germany
- Age of parental stock (mean and range, SD): Synchronized from cultured organisms 13 days before test insertion
- Breeding conditions:20 +/- 2 °C, diffuse light (100 - 1000 lx, 16 h photoperiod), dissolved oxygen concentration > 60 % of the air saturation value
- Handling of egg masses and larvae: 13 days before insertion into the test, the worms were synchronized. Therefore a sufficient amount of worms was taken from the breeding and cutted into half. After regeneration of heads, the worms were inserted into the test.
- Age of animals at beginning of exposure: 13 days after synchronisation, completely regenerated head region. Synchronisation was done to minimize uncontrolled regeneration and reproduction during the test.
- Feeding during test
- Food type: Powder of Urtica dioica (Heinrich Klein GmbH & Co KG, 97525 Schwebheim, Germany)
- Amount:0.5 % Urtica powder
- Frequency: Urtica powder was mixed into the sediment once at test start
ACCLIMATION
- Acclimation period: 13 days (after synchronisation)
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: same as test
- Feeding frequency: Once, same as test
- Health during acclimation (any mortality observed): No mortality observed - Study type:
- laboratory study
- Test type:
- static
- Water media type:
- freshwater
- Type of sediment:
- artificial sediment
- Limit test:
- yes
- Duration:
- 28 d
- Exposure phase:
- total exposure duration
- Hardness:
- Day 0: Control: > 356 mg/L CaCO3, Solvent Control: 340 mg/L CaCO3, 1000 mg test substance/kg sediment DW: > 356 mg/L CaCO3 Day 28: Control, Solvent Control, 1000 mg test substance/kg sediment DW: > 356 mg/L CaCO3
- Test temperature:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
2 Temperature [°C] 21.1 21.0 21.0
7 Temperature [°C] 21.9 21.2 21.3
14 Temperature [°C] 22.0 20.2 20.9
21 Temperature [°C] 21.8 21.8 21.5
28 Temperature [°C] 21.8 21.2 21.2 - pH:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
2 pH 7.74 7.82 7.84
7
pH 7.86 7.86 7.83
14
pH 7.76 7.79 7.84
21
pH 7.58 7.87 7.92
28
pH 8.22 8.27 8.28 - Dissolved oxygen:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 O2 [mg/L] 6.16 6.78 6.93
7 O2 [mg/L] 6.06 6.05 6.33
14 O2 [mg/L] 6.90 6.22 6.91
21
28 O2 [mg/L] 7.37 7.11 7.01
O2 [mg/L] 7.30 8.04 8.47 - Salinity:
- Not measured (Freshwater)
- Ammonia:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 NH4-N [mg/L] 0.803 0.622 0.759
2 NH4-N [mg/L] 0.114 < 0.02* 0.247
5 NH4-N [mg/L] 0.039 0.031 0.026
8 NH4-N [mg/L] 0.045 0.039 0.039
9 NH4-N [mg/L] 0.091 0.050 0.035
12 NH4-N [mg/L] 0.064 0.060 0.041
15 NH4-N [mg/L] 0.089 0.241 0.185
16 NH4-N [mg/L] 1.03 0.715 0.154
19 NH4-N [mg/L] > 2.5* > 2.5* > 2.5*
NH4-N [mg/L] 5.71 5.35 3.23
23 NH4-N [mg/L] 4.84 4.75 4.71
26 NH4-N [mg/L] 6.91 6.01 5.47
28 NH4-N [mg/L] 6.76 6.58 5.28
*) below or above range of analysis of the used cuvette detection test - Nominal and measured concentrations:
- Nominal concentration: 1000 mg test substance/kg sediment DW
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 250 mL glass beakers (6 cm diameter)
- Sediment volume: 45 g dry weight per vessel, ca. 2 cm from the ground
- Overlying water volume: 150 mL
- Depth of sediment and overlying water: Sediment: ca. 2 cm, overlying water ca. 10 cm
- Aeration: yes
- Aeration frequency and intensity: Gentle aeration, ca. two bubbles/sec.
- Replacement of evaporated test water, if any: Yes, once weekly
EXPOSURE REGIME
- No. of organisms per container (treatment): 10 per container (60 per treatment)
- No. of replicates per treatment group: 6 replicates per treatment group
- No. of replicates per control / vehicle control: 6 replicates per control/vehicle control
- Feeding regime: Once at test start
- Type and preparation of food: Powder of Urtica dioica, mixed into the sediment before insertion of test organisms
- Amount of food: 0.5 %
OVERLYING WATER CHARACTERISTCS
- Type of water (e.g. deionized, ground water, sea water, Elendt medium acc. to OECD 219): Reconstituted water acc. to OECD 203
CHARACTERIZATION OF (ARTIFICIAL; delete if not applicable) SEDIMENT
- Composition (if artificial substrate):
5 % peat, air dried and finely ground, 20 % kaolin, 75 % quartz sand, 0,33 % calcium carbonate
Table 1: Sediment Properties at Test Start
Total Organic Carbon [%] pH-value Moisture [%]
Sediment at test start 2.15 6.74 8.29
OTHER TEST CONDITIONS
Table 2: Environmental Conditions
Room temperature [°C] Photoperiod [h] Light intensity [lx]
Nominal 20 +/- 2 16 100 - 1000
Actual 18 ¿ 21 16 472 ± 47.2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behavioural changes (Day 0 - 28), Biomass and reproduction (Day 28)
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 - 100 - 1000 mg test substance/kg sediment DW
- Results used to determine the conditions for the definitive study:
Table 3: Range Finding Test (14 d): Mortality and Biomass
Concentration Mortality Mean number of worms Mean dry weight
[mg test item/kg sediment DW] [%] [mg]
Control 0 13.5 14.7
Solv. Control 0 14.5 16.0
10 0 14.0 19.3
100 0 11.5 7.95
1000 0 14.0 10.4 - Reference substance (positive control):
- no
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg sediment dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks:
- & biomass, behaviour, mortality
- Details on results:
- - Mortality of test animals at end of exposure period: No mortality
- Total mass of test animals at beginning of test: 10 worms were equal to ca. 45.8 mg wet mass
- Changes in body weigth of live adults (% of initial weight) at end of exposure period:
Table 1: Worm Dry Biomass after 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] Dry weight [mg]
Replicate per Repl. per worm
1 2 3 4 5 6 MV +/- SD MV +/- SD
Control 7.10 12.7 18.2 14.0 13.5 13.0 14.8 ± 3.27 0.63 ± 0.11
Solvent Control 15.5 20.3 14.9 15.7 16.7 16.0
1000 13.4 12.9 22.5 21.0 12.8 13.5 16.0 ± 4.47 0.71 ± 0.08
- No. of offspring produced:
Table 2: Reproduction after 28 days of Exposure
Nominal conc.
[mg/kg sediment DW] Number of incomplete worms
1 2 3 4 5 6 MV SD % Inhibition Significance*
Control 7 9 21 10 13 12 12.9 4.76 -
Solvent Control 11 22 15 16 9 10
1000 11 8 18 25 6 12 13.3 7.03 -3.23 No
- Morphological abnormalities: None
- Behavioural abnormalities: None - Reported statistics and error estimates:
- One Way Analysis of Variance (ANOVA, Kruskal-Wallis) was
carried out with worm numbers and biomass data for the determination of statistically significant differences compared to the pooled control. Prior to the ANOVA a normality test and an equal variance test were conducted. P-values for both normality and equal variance test were 0.05. The ¿-value (acceptable probability of incorrectly concluding that there is a difference) for ANOVA was ¿=0.05. - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study the submission substance caused no significant effects on mortality, behaviour, biomass and reproduction at the limit test item concentration of 1000 mg/kg sediment DW. Thus, the NOEC was determined to be >/= 1000 mg/kg sediment DW.
- Executive summary:
Effects of the submission substance on the oligochaete Lumbriculus variegatus in a water-sediment system were determined. The study was carried out according to OECD Guideline 225 (2007) compliant to GLP (reliability category 1). Test duration was 28 days after insertion of the test organisms. A limit test with the nominal test concentration of 1000 mg/kg sediment dry weight (DW) was performed by spiking the test item into the sediment. Six replicates per control, vehicle control and limit test item concentration with ten worms per replicate were set up. Water quality parameters as temperature, pH-value, O2-concentration, ammonia and total hardness were determined.
Due to the chemical properties of the test item the fraction of the pigment in the overlying water as well as in the porewater can be neglected. Thus, no analytical verification of the test item was performed.
After 28 days no significant mortality or behavioural changes of L. variegatus were observed at the limit test item concentration of 1000 mg/kg sediment DW. Also, the biomass was not significantly reduced compared to the pooled control after 28 days of exposure to the test item. L. variegatus reproduced without any significant differences between the pooled control and the limit test item concentration of 1000 mg/kg sediment DW (Table 1).
Table 1: Summary of all Significant Effects
Effects
Test Item
Significance of effects
[mg/kg sediment DW]
Mortality
> 1000
Behaviour
> 1000
Biomass
> 1000
Reproduction
> 1000
NOEC
(mortality, behaviour, biomass, reproduction)
>= 1000
- Endpoint:
- sediment toxicity: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-01-06 to 2010-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study compliant to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Draft ISO/DIS 10872 (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to German Chemikaliengesetz and Directive 88/320/EEC
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on sediment and application:
- PREPARATION OF SPIKED SEDIMENT
- Pooling or mixing of different substrates:
Modified artificial sediment:
- 70 % quartz sand (with > 50 % particles sized between 50 and 200 µm)
- 20 % Al2O3
- 4.5 % Fe2O3
- 4 % peat, air dried and finely ground
- 0.3 % CaCO3
- 0.5 % dolomite (clay)
The pH-value and the moisture of the artificial sediment were determined. One day prior to introduction of the nematodes the sediment was moistened with M9 medium to a moisture of 44 %.
- Details of spiking: The respective test item amount for the limit concentration was weighed out and dissolved in acetone. Subsequently, the solution was thoroughly mixed with quartz sand (20 % of the entire sediment amount) in a glass vessel. After complete evaporation of the solvent, the dry quartz sand was given to the sediment and thoroughly mixed with the sediment.
Additional M9 medium* was added to the sediment to obtain a water content of 44 %. Subsequently, 0.5 g sediment wet weight was filled into each test well.
- Equilibration time: 1 day
- Equilibration conditions: 8 +/- 2 °C, dark
- Controls: Moistened test sediment was tested under the same conditions as the test replicates.
*) M9 medium: 13.95 g Na2HPO4+ 12 H2O corresponding to 6 g Na2HPO4, 3 g KH2PO4, 5 g NaCI and 0.25 g MgSO4 x 7H2O dissolved in 1000 mL demineralised water and autoclaved.
- Test organisms (species):
- Caenorhabditis elegans
- Details on test organisms:
- TEST ORGANISM
- Common name: Nematode
- Strain/clone: Wilde type strain N2 var Bristol
- Source: Caenorhabditis Genetics Center, Minneapolis
- Breeding conditions:Breeding is performed at the test facility at 20 +/- 2 °C in the dark on agar plates containing NGM (nematode growth medium) agar inoculated with Escherichia coli OP 50.
- Age of animals at beginning of exposure: First stage juveniles were obtained by filtering nematode solutions from culture plates through nylon nets (10 µm and subsequently 5 µm mesh size). The size of 30 representative juvenile nematodes, which were not used in the test, was determined prior to nematode insertion.
- Feeding during test
LB-medium* was inoculated with E. coli OP50 one day prior to the insertion of the test organisms. About 21.5 hours after inoculation the food bacteria were washed with M9 medium and concentrated in M9 medium by centrifugation. 0.5 mL of the food medium was provided once prior to the addition of the nematodes to each test replicate.
*) LB-medium: 10 g casein peptone, 5 g yeast extract, 10 g NaCl dissolved in 1000 mL demineralised water and autoclaved.
ACCLIMATION
- Acclimation period: None, test conditions = breeding conditions - Study type:
- laboratory study
- Test type:
- static
- Water media type:
- freshwater
- Type of sediment:
- artificial sediment
- Limit test:
- yes
- Duration:
- 96 h
- Exposure phase:
- total exposure duration
- Nominal and measured concentrations:
- Nominal: 1000 mg test item/kg sediment dry weight
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Nunc Polystyrol Multiwells (12 well microtiter plates)
- Sediment volume: 0.5 g sediment wet weight per replicate
- Overlying water volume: 0.5 mL food medium (see above)
- Aeration: no
- Replacement of evaporated test water, if any: No
Controls:
Control: Moistened test sediment with the addition of quartz sand (20% of entire sediment amount) was tested under the same conditions as the test replicates.
Solvent control: Moistened test sediment with the addition of quartz sand with acetone was tested under the same conditions as the test replicates.
Liquid Control: Tap water (0.55 ml) without sediment was tested under the same test conditions as the test replicates.
EXPOSURE REGIME
- No. of organisms per container (treatment): 40
- No. of replicates per treatment group: 6
- No. of replicates per control / vehicle control: 6
- No. of replicates for the liquid control: 4
- Type and preparation of food: LB-medium* was inoculated with E. coli OP50 one day prior to the insertion of the test organisms. About 21.5 hours after inoculation the food bacteria were washed with M9 medium and concentrated in M9 medium by centrifugation. 0.5 mL of the food medium was provided once prior to the addition of the nematodes to each test replicate.
*) LB-medium: 10 g casein peptone, 5 g yeast extract, 10 g NaCl dissolved in 1000 mL demineralised water and autoclaved.
CHARACTERIZATION OF (ARTIFICIAL; delete if not applicable) SEDIMENT
- Composition (if artificial substrate):
Modified artificial sediment:
- 70 % quartz sand (with > 50 % particles sized between 50 and 200 µm)
- 20 % Al2O3
- 4.5 % Fe2O3
- 4 % peat, air dried and finely ground
- 0.3 % CaCO3
- 0.5 % dolomite (clay)
The pH-value and the moisture of the artificial sediment were determined. One day prior to introduction of the nematodes the sediment was moistened with M9 medium to a moisture of 44 %.
- Maturation of artificial substrate (if any): no
OTHER TEST CONDITIONS
- Continuous dark
The initial pH of the artificial sediment at test start was 6.7. The initial sediment moisture was
5.5 %. The room temperature ranged from 19.0 to 21.0 °C.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The recovery / mortality of the inserted nematodes was analysed by counting the adult nematodes under a microscope. The body length of each female adult nematode was determined with a microscale.
The reproduction was analysed by inserting the extracted nematodes in a counting chamber. The produced number of offspring was determined in the specified volume of the counting chamber under a microscope. The total number of offspring per replicate was calculated by using the entire volume of extract.
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: none
- Range finding study
Range Finding Test (96 h): Recovery, Mortality and Reproduction
Test Item Concentration Recovery of adult nematodes Fertility of adult nematodes Reproduction
[mg test item/kg soil dry weight] [%] [%] [Offspring per inserted test organism]
Control 83.3 100 42.0
Solv. control 90.0 100 44.8
10 90.0 100 46.0
100 96.7 100 51.7
1000 93.3 100 42.6 - Reference substance (positive control):
- yes
- Remarks:
- Benzyldimethylhexadecylammonium chloride
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/kg sediment dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortaliy, fertility, reproduction, growth
- Details on results:
- - Mortality of test animals at end of exposure period: In the artificial sediment a recovery of 90 % was observed in the pooled control after 4 days of exposure. At the limit test item concentration of 1000 mg test item/kg sediment dry weight the recovery was also 90 %. The resulting mortality was not considered to be of biological significance, and was within the range of experimental variation considered acceptable for the control group.
- No. of offspring produced: All female nematodes in the control as well as at the limit test item concentration were observed to be fertile. This also applies to the surviving nematodes in the reference item concentrations.
The reproduction in artificial sediment was not statistically significant reduced compared to the pooled control at the limit test item concentration of 1000 mg test item/kg sediment dry weight. The reproduction rates at the reference item concentrations of 10 and 15 mg reference item/L were statistically significant reduced compared to the pooled control by 40.7 % at 10 mg/L and by 97.0 % at 15 mg/L
- Growth: The initial mean size of the introduced juvenile nematodes was 230.4 µm.
In artificial sediment the growth of the adult nematodes did not statistically significantly differ compared to the pooled control at the limit test item concentrations of 1000 mg test item/kg sediment dry weight.
At 10 and 15 mg reference item/L the growth of the nematodes was statistically significantly reduced compared to the pooled control
- Morphological abnormalities: Not observed
- Behavioural abnormalities: Not observed - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- % recovered test organisms in the control: 100%
- Relevant effect levels:
Effects Reference Item Benzyldimethylhexadecylammonium chloride [mg/L]
LOEC (Mortality, Fertility, Reproduction, Growth) 5
NOEC (Mortality, Fertility, Reproduction, Growth) < 5
EC50 (Mortality) 15.0 (14.2 - 15.8)
EC50
(Reproduction) 10.2 (9.75 - 10.9)
EC50
(Size) 15.9 (11.5 - 23.4) - Reported statistics and error estimates:
- t-tests were used for LOEC and NOEC calculations. Prior to running the t-tests a Normality and an Equal Variance Test were done. P-values for both Normality and Equal Variance Test are 0.05. The a-value (acceptable probability of incorrectly concluding that there is a difference) is a = 0.05.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study the submission substance did not induce significant mortality of C. elegans after an exposure to the limit test item concentration of 1000 mg test item/kg sediment dry weight for 96 hours. Also, adult nematode fertility as well as nematode reproduction was not affected at 1000 mg test item/kg sediment dry weight.
No reduction of growth was observed at the limit test item concentration of 1000 mg test item/kg sediment dry weight after four days of exposure to the submision substance compared to the pooled control.
Thus, the Lowest Observed Effect Concentration (LOEC) concerning all test parameters was set at > 1000 mg test item/kg sediment dry weight. The Overall No Observed Effect Concentration (NOEC) was determined to be 1000 mg test item/kg sediment dry weight. All effect levels given are based on the nominal concentrations of Pigment Red 187. - Executive summary:
Effects of the submission substance on the bacterivorous nematode Caenorhabditis elegans in a sediment system were determined. The study was carried out according to the Draft guideline ISO/DIS 10872 (2008). Test duration was 96 hours after insertion of the test organisms. The study was performed by spiking the test item into the sediment with the limit test item concentration of 1000 mg test item/kg sediment dry weight. Six replicates per control, solvent control and limit test item concentration were set up.
After four days of exposure to the limit test item concentration of 1000 mg test item/kg sediment dry weight the submission substance did not induce biologically significant mortality of C. elegans. Also, adult nematode fertility as well as nematode reproduction was not affected at 1000 mg test item/kg sediment dry weight.
Accordingly, no statistically significant reduction of growth was observed at the limit test item concentration of 1000 mg test item/kg sediment dry weight after an exposure of 96 hours to the submission substance.
Thus, the Lowest Observed Effect Concentration (LOEC) concerning all test parameters was set at > 1000 mg test item/kg sediment dry weight. The Overall No Observed Effect Concentration (NOEC) was determined to be 1000 mg test item/kg sediment dry weight. All effect levels given are based on the nominal concentration of the submission substance.
Summary of all Effects and resulting LOEC, NOEC based on nominal concentrations
Effects
Submission substance
[mg test item/kg sediment dry weight]
Mortality
> 1000
Fertility
> 1000
Reproduction
> 1000
Growth
> 1000
LOEC
(Mortality, Fertility, Reproduction, Growth)
> 1000
NOEC
(Mortality, Fertility, Reproduction, Growth)
1000
- Endpoint:
- sediment toxicity: long-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to the analogue approach provided in the CSR.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg sediment dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality, fertility, reproduction, growth
- Remarks on result:
- other:
- Remarks:
- Noack, 2010
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg sediment dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks:
- mortality, behavior, biomass
- Remarks on result:
- other:
- Remarks:
- Noack, 2009
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg sediment dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks:
- mortality, biomass, behavior
- Remarks on result:
- other:
- Remarks:
- Noack, 2008
Referenceopen allclose all
Mortality/Reproduction of worms:
After 28 days of exposure to the limit test item concentration the total number of worms did not differ significantly compared to the pooled control (Table 1). No mortality of complete worms was observed due to the exposure to the limit test item concentration of 1000 mg/kg sediment DW over a period of 28 days (Table 2). Also, the number of incomplete worms and thus the reproduction did not significantly differ to the pooled control at test end (Table 3).
Table 1: Total Worm Number after 28 days of Exposure
Nominal conc. |
Total Number of |
|||||||||
Day 28 |
||||||||||
[mg/kg sediment DW] |
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Inhibition |
Significance* |
Control |
17 |
19 |
31 |
20 |
23 |
22 |
22.9 |
4.76 |
- |
- |
Solvent Control |
21 |
32 |
25 |
26 |
19 |
20 |
||||
1000 |
20 |
20 |
22 |
20 |
22 |
18 |
20.3 |
1.51 |
11.3 |
No |
Table 2: Mortality after 28 days of Exposure
Nominal conc. [mg/kg sediment DW] |
Total Number of Complete |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Mortality |
Significance |
|
Control |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
0 |
0 |
- |
Solvent Control |
10 |
10 |
10 |
10 |
10 |
10 |
||||
1000 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
0 |
0 |
No |
Table 3: Reproduction after 28 days of Exposure
Nominal conc. [mg/kg sediment DW] |
Number of incomplete worms |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Inhibition |
Significance* |
|
Control |
7 |
9 |
21 |
10 |
13 |
12 |
12.9 |
4.76 |
- |
|
Solvent Control |
11 |
22 |
15 |
16 |
9 |
10 |
||||
1000 |
10 |
10 |
12 |
10 |
12 |
8 |
10.3 |
1.51 |
20.0 |
No |
No difference in the worm behaviour was observed at the limit test item concentration of 1000 mg/kg sediment DW compared to the pooled control during the entire study (Table 4).
Table 4: Worm Behaviour during 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] |
Effect |
Days after insertion (pooled replicates) |
||||||||||||
0 |
2 |
5 |
7 |
9 |
12 |
14 |
16 |
19 |
21 |
23 |
26 |
28 |
||
Control |
s) |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
Solvent Control |
s) |
60 |
60 |
58 |
60 |
60 |
60 |
60 |
59 |
60 |
60 |
60 |
60 |
60 |
a) |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
1000 |
s) |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
conc. = concentration DW = Dry Weight
s) = worm burrowing in sediment a) = worm on sediment surface t) = dead
Dry biomass of the worms
The dry biomass of the worms at the limit test item concentration of 1000 mg/kg sediment DW did not differ significantly to the pooled control (Table 5).
Table 5: Worm Dry Biomass after 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] |
Dry weight [mg] |
||||||||
Replicate |
per Repl. |
Significance* |
per worm |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV ± SD |
MV ± SD |
||
Control |
7.10 |
12.7 |
18.2 |
14.0 |
13.5 |
13.0 |
14.8 ± 3.27 |
- |
0.65 ± 0.12 |
Solvent Control |
15.5 |
20.3 |
14.9 |
15.7 |
16.7 |
16.0 |
|||
1000 |
13.7 |
14.4 |
19.0 |
12.3 |
16.8 |
13.3 |
14.9 ± 2.51 |
No |
0.73 ± 0.08 |
Mortality/Reproduction of worms:
After 28 days of exposure to the limit test item concentration the total number of worms did not differ significantly compared to the pooled control (Table 1). No significant mortality of complete worms was observed due to the exposure to the limit test item concentration of 1000 mg/kg sediment DW over a period of 28 days (Table 2). Also, the number of incomplete worms and thus the reproduction did not differ to the pooled control at test end (Table 3).
Table 1: Total Worm Number after 28 days of Exposure
Nominal conc. |
Total Number of Worms |
|||||||||
Day 28 |
||||||||||
[mg/kg sediment DW] |
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Inhibition |
Significance* |
Control |
17 |
19 |
31 |
20 |
23 |
22 |
22.9 |
4.76 |
- |
- |
Solvent Control |
21 |
32 |
25 |
26 |
19 |
20 |
||||
1000 |
19 |
18 |
28 |
35 |
16 |
21 |
22.8 |
7.25 |
0.36 |
No |
Table 2: Mortality after 28 days of Exposure
Nominal conc. [mg/kg sediment DW] |
Total Number of Complete Worms |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Mortality |
Significance* |
|
Control |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
0 |
0 |
- |
Solvent Control |
10 |
10 |
10 |
10 |
10 |
10 |
||||
1000 |
8 |
10 |
10 |
10 |
10 |
9 |
9.5 |
0.84 |
5 |
No |
Table 3: Reproduction after 28 days of Exposure
Nominal conc. [mg/kg sediment DW] |
Number of incomplete worms |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Inhibition |
Significance* |
|
Control |
7 |
9 |
21 |
10 |
13 |
12 |
12.9 |
4.76 |
- |
|
Solvent Control |
11 |
22 |
15 |
16 |
9 |
10 |
||||
1000 |
11 |
8 |
18 |
25 |
6 |
12 |
13.3 |
7.03 |
-3.23 |
No |
Behaviour and pathological symptoms:
No difference in the worm behaviour was observed at the limit test item concentration of 1000 mg/kg sediment DW compared to the pooled control during the entire study (Table 4).
Table 4: Worm Behaviour during 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] |
Effect |
Days after insertion (pooled replicates) |
||||||||||||
0 |
2 |
5 |
7 |
9 |
12 |
14 |
16 |
19 |
21 |
23 |
26 |
28 |
||
Control |
s) |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
Solvent Control |
s) |
60 |
60 |
58 |
60 |
60 |
60 |
60 |
59 |
60 |
60 |
60 |
60 |
60 |
a) |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
1000 |
s) |
60 |
60 |
60 |
60 |
59 |
57 |
57 |
57 |
57 |
57 |
57 |
57 |
56 |
a) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
t) |
0 |
0 |
0 |
0 |
1 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
s) = worm burrowing in sediment a) = worm on sediment surface t) = dead
Dry biomass of the worms:
The dry biomass of the worms at the limit test item concentration of 1000 mg/kg sediment DW did not differ significantly to the pooled control (Table 5).
Table 5: Worm Dry Biomass after 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] |
Dry weight [mg] |
||||||||
Replicate |
per Repl. |
per worm |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV ± SD |
MV ± SD |
||
Control |
7.10 |
12.7 |
18.2 |
14.0 |
13.5 |
13.0 |
14.8 ± 3.27 |
0.63 ± 0.11 |
|
Solvent Control |
15.5 |
20.3 |
14.9 |
15.7 |
16.7 |
16.0 |
|||
1000 |
13.4 |
12.9 |
22.5 |
21.0 |
12.8 |
13.5 |
16.0 ± 4.47 |
0.71 ± 0.08 |
Recovery / Mortality after 4 Days of Exposure to submission substance
Nominal test item concentration [mg test item/kg sediment dry weight] |
[%] Recovered test organisms |
Mortality |
|||||||
Replicate |
MV |
SD |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
||||
Liquid Control |
100 |
90 |
90 |
100 |
- |
- |
95.0 |
5.77 |
5.00 |
Control |
90 |
80 |
90 |
100 |
100 |
90 |
90.0 |
7.39 |
10.0 |
Solvent Control |
90 |
80 |
80 |
90 |
90 |
100 |
|||
1000 |
90 |
90 |
90 |
90 |
100 |
80 |
90.0 |
6.32 |
10.0 |
Nematode Reproduction after 4 Days of Exposure to submision substance
Nominal test item concentration [mg test item/kg sediment dry weight] |
Number of offspring per inserted nematode |
||||||||
Replicate |
MV |
SD |
Inhibition [%] |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
||||
Control |
38 |
35 |
35 |
45 |
35 |
34 |
36.7 |
3.61 |
- |
Solvent Control |
35 |
34 |
32 |
38 |
41 |
38 |
|||
1000 |
35 |
40 |
34 |
38 |
35 |
32 |
35.7 |
2.98 |
2.72 |
Nematode Growth after 4 Days of Exposure to submission substance
Nominal test item concentration [mg test item/kg sediment dry weight] |
Mean Growth [µm] |
||||||||
Replicate |
MV |
SD |
Inhibition [%] |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
||||
Control |
772 |
802 |
799 |
799 |
816 |
794 |
798 |
11.8 |
- |
Solvent Control |
799 |
796 |
808 |
784 |
810 |
804 |
|||
1000 |
810 |
804 |
826 |
760 |
802 |
760 |
793 |
27.5 |
0.62 |
Description of key information
EC10 / NOEC freshwater sediment organisms ≥ 1000 mg/kg sed. dw
Key value for chemical safety assessment
Additional information
Pigment Orange 38 and Pigment Red 187 were both tested in reliable studies (reliability category 1) with the oligochaete Lumbriculus variegatus according to OECD Guideline 225 and compliant to GLP. Endpoints assessed were mortality, behaviour, biomass and reproduction during the 28 days of the test. Limit tests were performed by spiking the sediment with nominally 1000 mg/kg sediment dry weight. Consistently, no effects were observed at the nominal limit concentration. The validity criteria of the guideline were met.
Additionally, PR 187 had been tested on the sediment dwelling nematode Caenorhabditis elegans according to Draft ISO/DIS 10872 (2008) guideline (finalized 2010) (reliability category 1). Assessed endpoints were mortality, fertility, reproduction and growth. The study was performed by spiking the test item into the sediment with the limit test item concentration of 1000 mg test item/kg sediment dry weight. Six replicates per control, solvent control and limit test item concentration were set up. No adverse effects could be observed in regard to all assessed endpoints.
From these three tests performed on sediment dwelling organisms of different taxonomic groups (Nematoda and Oligochaeta), which included the assessment of reproduction, it can be concluded that the Naphtol-AS Pigments are chronically non-toxic to sediment dwelling organisms.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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.