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EC number: 236-852-7 | CAS number: 13515-40-7
- 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
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Toxicity to microorganisms
Administrative data
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 NOV 2004 to 26 NOV 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to relevant guidelines and compliant to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- yes
- Remarks:
- Reference substance used: copper (II) sulphate pentahydrate instead of 3,5-dichlorophenol. The range of validity (EC50 ± 3SD) of copper (II) sulfate pentahydrate is calculated from the mean of all reference tests from 1991 - 2004 (n = 227).
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to § 19b Abs. 1 German Chemikaliengesetz and directive 88/320/EEC
Test material
- Reference substance name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- EC Number:
- 219-730-8
- EC Name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- Cas Number:
- 2512-29-0
- Molecular formula:
- C17H16N4O4
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test item was weighed out directly into an Erlenmeyer flask,
filled with 250 mL autoclaved tap water and stirred for 24 h.
Dispersion treatment: Agitation
Test concentration: Limit-test at 1000 mg/L
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- TEST SYSTEM: Activated sludge
Reason for the selection of study system: Non adapted activated sludge from the sewage plant at Sarstedt is well suited as it comprises mostly domestic sewage and hardly industrial waste water.
Origin: Domestic sewage treatment plant of D-31157 Sarstedt
Pretreatment: The sludge was washed twice with autoclaved tap water and diluted corresponding to a dry weight of 4.0 g/L +/- 10 %.
Date of receipt: 2004-11-26
Dry sludge concentration: 3.87 g/L
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
Test conditions
- Test temperature:
- 18-22 deg C
- pH:
- 6.94
- Dissolved oxygen:
- See table on measurements under "any other information on results including tables"!
- Nominal and measured concentrations:
- Limit test at nominal 1000 mg/L submission substance
- Details on test conditions:
- 2 control samples without test item were included, one at the beginning and one at the end of the test.
TEST METHOD: Static
Test duration 3 h
Replicates: One per concentration and two per control
Test vessels: 500 mL Erlenmeyer flasks, DIN 12380
Volume of the study medium: 500 mL
Nutrient solution: Synthetic waste water according to OECD 209
Application:
200 mL inoculum
16 mL synthetic waste water
284 mL autoclaved tap water
Test item concentration (directly weighing)
Test temperature: 18 - 22 °C
Ventilation: Permanent
TYPE AND FREQUENCY OF MEASUREMENT and OBSERVATIONS:
The pH value of the activated sludge was measured prior to testing and the temperature in the measuring cell once during the measurement. The oxygen depletion of the control, reference and
test item was measured after 3 h incubation by means of oximeter and recorded for at least 3 minutes on a flat bed recorder.
The room temperature during the test was recorded continuously by a hygrothermograph.
COURSE OF THE STUDY:
A range-finding test (NON-GLP-state) was carried out with three concentrations: 10 - 100 - 1000 mg/L.
Based on the results of the preliminary test the study was carried out with a limit test concentration of 1000 mg/L. 2 control replicates without test item were included.
A fresh sample of activated sludge taken from the sewage plant Sarstedt was used for the test procedure. It was washed twice and diluted with autoclaved tap water to a dry sludge concentration of 4.0 g/L +/- 10 %.
The reference item was tested in three concentrations within the concentration range 58 - 180 mg/L with a dilution factor of 1.8.
The respiration rates of all samples were determined subsequently to an incubation period of 3 h.
EVALUATION:
Determined are the distances recorded by a flat bed recorder (adjusted to 500 mV and 1 cm/min in y-direction) during 3 min measurement for each test vessel.
5 mm on the recorder (x-direction) are equivalent to a decrease of 0.1 mg O2/L. That leads to the factor f = 0.02 mg O2/L x mm.
The respiration rate (R) according to the raw data was calculated in the following way:
R = md x f x t
R : respiration rate mgO2/Lxh
md : measured distance mm/3min
f : 0.02 mgO2/Lxmm
t : 20 [3min/h]
The inhibition of respiration rates were calculated by a standard method as outlined in OECD 209. - Reference substance (positive control):
- yes
- Remarks:
- Copper (II) sulphate pentahydrate p.a.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Key result
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Details on results:
- The test item was hardly soluble. After stirring for 24 h the test item was mostly dispersed. Only part of the test item floated on the surface or stuck to the side of the flask.
For further details see section "Any other information on results including tables". - Results with reference substance (positive control):
- REFERENCE ITEM Copper (II) sulphate pentahydrate p.a. MERCK
CAS RN 7758-99-8
Lot A265990
Purity 99.9 %
Expiry date 2005-11-30
Test concentrations 58 - 100 - 180 mg/L
Range of validity (EC50) 53 - 155 mg/L
In the reference test the EC50 -value for copper(II)-sulphate-pentahydrate was determined by probit analysis with:
EC50 = 125 mg/L
This is in the recommended confidence range of 53 - 155 mg/L. - Reported statistics and error estimates:
- The EC20- and EC50-values were calculated with probit analysis using software SIGMAPLOT (Windows) rel. 8.02, 2002, SPSS CORPORATION.
Probit values were taken from WEBER (1986).
Confidence intervals were calculated according to a standard procedure (BREITIG & TÜMPLING 1982).
Any other information on results incl. tables
Raw Data and Respiration Rates of Test and Reference Item Concentrations
|
Concentration |
Oxygen- |
Measured |
Respiration rate |
Test item |
1000 |
7.01 |
81 |
32.4 |
Control 1 |
- |
4.84 |
73 |
29.2 |
Control 2 |
- |
6.65 |
83 |
33.2 |
Reference item |
180 |
9.97 |
21 |
8.4 |
|
100 |
8.89 |
47 |
18.8 |
|
58 |
7.84 |
73 |
29.2 |
* determined at the start of the 3 minute measurement
** 5 mm are related to 0.1 mgO2/L
Respiration Rates and Inhibition of Respiration of Test and Reference ItemConcentrations
|
Concentration |
Respiration rate |
Inhibition |
Test item |
1000 |
32.4 |
-4 |
Control 1 |
- |
29.2 |
- |
Control 2 |
- |
33.2 |
- |
Reference item |
180 |
8.4 |
73 |
|
100 |
18.8 |
40 |
|
58 |
29.2 |
6 |
Difference of the control respiration rates: 12 %
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a respiration inhibition test with activated sludge according to OECD 209 no respiration inhibition was observed at the nominal test item concentration of 1000 mg/L (limit test).
EC50 (3h) > 1000 mg/L (nominal)
NOEC (3h) = 1000 mg/L (nominal) - Executive summary:
A Respiration Inhibition Test with activated sludge according to OECD Guideline No. 209 and compliant to GLP (reliability category 1) was performed for 3 h with the submission substance. Test system was activated sludge of a domestic treatment plant. The test was performed under static conditions with the nominal concentration 1000 mg/L. The respiration rates of control, reference and test item concentrations were measured after a contact time of three hours, and the inhibitory effects of the test and reference concentrations were determined in comparison to the control respiration rates. No inhibition was observed. In order to check the activity of the test system and the test conditions a reference test was carried out with copper-(II)-sulphate-pentahydrate as reference item and the reference toxicity was determined. The EC50 value for the reference item was 125 mg/L. Validity criteria of the test guideline were fulfilled. The submission substance is not toxic at concentrations up to 1000 mg/L to activated sludge of a domestic sewage treatment plant.
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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