Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 953-704-3 | CAS number: 2411191-47-2
- 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 microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 October 2019 to 22 October 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Temperatures recorded continuously were situated between 17.7 and 20.7°C throughout the test (average value: 19.7°C), which was slightly lower than the requirements value: 20 ± 2 °C. This minor deviation was considered not to affect the results of the test as no impact was observed on the blank controls (all validity criteria of the test have been fulfilled).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation))
- Deviations:
- yes
- Remarks:
- Temperatures recorded continuously were situated between 17.7 and 20.7°C throughout the test (average value: 19.7°C), which was slightly lower than the requirements value: 20 ± 2 °C.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test)
- Deviations:
- yes
- Remarks:
- Temperatures recorded continuously were situated between 17.7 and 20.7°C throughout the test (average value: 19.7°C), which was slightly lower than the requirements value: 20 ± 2 °C.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspection dates: 29-30-31 May 2018 / Signature date: 15 November 2018
- Specific details on test material used for the study:
- - Appearance: From very light yellow to yellow liquid
- Storage condition of test material: Room temperature. Keep only in the original container in an appropriate place.
- Water solubility: 50.3 mg/L at 20°C (LPL 2020, OECD 105/EU A.6, slow-stirring method)
- Vapour pressure: 5.0 Pa at 20°C and 8.7 Pa at 25°C (LPL 2020, OECD 104/EU A.4, effusion method, Knudsen cell)
- Log Kow: 4.3 at 25°C (LPL 2020, OECD 123/EU A.23, slow-stirring method) - Analytical monitoring:
- not required
- Vehicle:
- no
- Details on test solutions:
- - Administration of the test and reference substances: The test vessels were 1 L cylindrical glass bottles closed with PTFE screw caps. A magnetic stirring bar was placed in each test vessel. Blank controls were prepared with 16 mL synthetic sewage feed and 234 mL test water. Test mixtures were prepared by addition of the required amounts of test item in pre-filled test vessels (with synthetic sewage feed and test water). 3,5-dichlorophenol (3,5-DCP) was used as a reference (positive control) in order to check the procedure. The 3,5-DCP stock solution was diluted with test water as necessary to obtain the required test concentrations into reference mixtures after filling with synthetic sewage and water. Then, 250 mL of sludge suspension were sequentially added in all test vessels. After addition of the inoculum, the test vessels were immediately closed and the mixtures were stirred under aeration for 3 hours.
- Test mixtures: Based on the results of the range-finding test, test solutions were prepared to obtain the following nominal test concentrations: 10, 100 and 1000 mg/L in order to determine
a concentration with no significant effect and/or to demonstrate that EC50 was higher than 1000 mg/L.
- Controls: Test water without test item but treated in the same way as the test mixtures. The test item was not known to have strong reducing properties, therefore it was judged not necessary to perform abiotic controls.
- Reference mixtures: The 3,5-DCP stock solution was diluted to obtain the following nominal concentrations (spaced by a factor of approximately 1.68): 5.0, 8.4, 14.1, 23.7 and 40.0 mg/L - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Origin:
Activated sludge was collected (14/10/2019) from a wastewater treatment plant (Aureilhan, France) receiving predominantly domestic sewage.
- Pretreatment: Upon arrival in the test facility, the sludge was sieved (using a 1 mm2 mesh sieve), washed 4 times with chlorine-free tap water and resuspended in tap water. The activated sludge was aerated and fed with the synthetic sewage feed (35 mL per L of sludge suspension) until the next day (final test). The dry weight of the sludge suspension was determined, then the sludge was diluted in chlorine-free tap water to obtain the required sludge solids concentration of approximately 3.0 g/L.
- Initial biomass concentration: The activated sludge concentration in all test, reference and blank mixtures was approx. 1.5 g/L of suspended solids - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Test temperature:
- Temperatures recorded continuously were situated between 17.7 and 20.7°C throughout the test (average value: 19.7°C), which was slightly lower than the requirements laid down in the guidelines (20 ± 2 °C) during 40 minutes. This minor deviation was considered not to affect the results of the test as no impact was observed on the blank controls (all validity criteria of the test have been fulfilled).
- pH:
- The pH of the reaction mixtures at the end of the test period ranged from 7.728 to 8.097.
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- - Nominal concentrations: 10, 100, 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: All-glass bottles of approximately 1 L capacity closed with PTFE screw caps, containing 500 mL of reaction mixture.
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 1 L capacity; 500 mL of reaction mixture
- Aeration: All suspensions were aerated and stirred during the exposure period.
- No. of vessels per concentration (replicates): 5 replicates bottles per test concentration containing synthetic sewage feed, test water, test item and inoculum (test mixtures)
- No. of vessels per control (replicates): 6 replicates bottles containing synthetic sewage feed, test water and inoculum (blank controls)
- No. of vessels per positive control (replicates): 1 replicate per reference substance concentration containing synthetic sewage feed, test water, reference substance and inoculum (reference
mixtures)
- Sludge concentration (weight of dry solids per volume): The activated sludge concentration in all test, reference and blank mixtures was approx. 1.5 g/L of suspended solids.
See details on content of test vessels in the Table 6.1.7/1 in "Any other information on materials and methods incl. tables'.
TEST MEDIUM / WATER PARAMETERS
- Test water: Deionised water, containing less than 1 mg/L DOC (Dissolved Organic Carbon).
- Test medium The medium was prepared by adding each of the following constituents at the stated amounts to each litre of ultrapure water:
Peptone = 16g; Meat extract = 11g; Urea = 3g; NaCl = 0.7g; CaCl2.2H2O = 0.4g; MgSO4.7H2O = 0.2g; K2HPO4 = 2.8g.
The pH of this solution was 7.14, in accordance with the requirements 7.5 +/- 0.5. This nutrient solution was refrigerated and stored in the dark before use.
OTHER TEST CONDITIONS
- Adjustment of pH: no
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Dissolved O2 (DO): After the exposure, samples from each mixture were poured into BOD bottles to continuously measure the oxygen concentration using an oxygen electrode and determine the rate of decrease of dissolved O2. The measurement of total oxygen uptake inhibition was determined only (carbon and ammonium oxidation not separated).
TEST CONCENTRATIONS
- Range finding study : A range-finding test was conducted between September 9 and September 10, 2019 to determine the range of concentrations for the definitive test. Microorganisms from activated sludge were exposed to the nominal test concentrations 10 (duplicates), 32, 100 (duplicates), 320 and 1000 mg/L (duplicates) and to a control. Test procedures and conditions were similar to those applied in the final test. All validity criteria were met (CV of oxygen uptake rate in control replicates: 9.0%; mean oxygen uptake rate in the blank controls: 30.8 mg O2/g dry weight activated sludge/h; EC50 of 3,5-DCP for total respiration: 15.1 mg/L). - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
- 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
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Details on results:
- After 3 hours of exposure, a slight effect on the respiration rate of activated sludge was observed at 100 and 1000 mg/L (average inhibition of 13.0 and 9.6%, respectively). Based on these results, the highest nominal test concentration without observed effects (= NOEC) was 10 mg/L; the 3-hour EC50 was estimated to be ≥ 1000 mg/L
. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: The EC50 of 3,5-DCP was 11.5 mg/L for total respiration and thus remained within the prescribed range of 2 to 25 mg/L. - Reported statistics and error estimates:
- Statistical analyses were performed by ToxRat.
- Validity criteria fulfilled:
- yes
- Remarks:
- The validity of the test was demonstrated: Oxygen uptake rate in the blank controls >20 mg O2/g/h; Coefficient of variation of oxygen uptake rate in control replicates <30%; EC50 = 11.5 mg/L for 3,5-DCP (within the range 2-25 mg/L for total respiration).
- Conclusions:
- After 3 hours of exposure, a slight effect on the respiration rate of activated sludge was observed at 100 and 1000 mg/L (average inhibition of 13.0 and 9.6%, respectively). No effect on the respiration rate was observed at 10 mg/L.
Therefore, under the experimental conditions and based on nominal concentrations, the 3h-EC50 value was estimated to be higher than 1000 mg/L. The NOEC value was 10 mg/L and the LOEC 100 mg/L. - Executive summary:
This study was performed according to OECD Guideline 209 and EU Method C.11 with GLP compliance to assess the effects of the test substance on microorganisms from activated sludge.
Following a preliminary range-finding test, microorganisms from activated sludge were exposed to the test substance at nominal concentrations of 10, 100 and 1000 mg/L (five replicates for each concentration) and to six blank controls in order to determine a concentration with no significant effect and to demonstrate that EC50 was higher than 1000 mg/L. Furthermore, an exposure of the test organism to chemical 3,5 -dichlorophenol (3,5 -DCP) was performed in order to check the sensitivity of the batch of activated sludge used on the day of exposure. All the mixtures contained an activated sludge concentration of about 1.5 g/L of suspended solids. After 3 hours of exposure under aeration and stirring, samples of each mixture were poured into BOD bottles to continuously measure the oxygen concentration using an oxygen electrode and determine the rate of decrease of dissolved O2. The measurement of total oxygen uptake inhibition was determined only (carbon and ammonium oxidation not separated).
After 3 hours of exposure, a slight effect on the respiration rate of activated sludge was observed at 100 and 1000 mg/L (average inhibition of 13.0 and 9.6%, respectively). No effect on the respiration rate was observed at 10 mg/L.
Therefore, under the experimental conditions and based on nominal concentrations, the 3h-EC50 value was estimated to be higher than 1000 mg/L. The NOEC value was 10 mg/L and the LOEC 100 mg/L.
Reference
Table 6.1.7/2: Range-finding test results (respiration rate and inhibition at the end of the test)
|
|
Total respiration (RT) |
|
Content |
Concentration (mg.L-1) |
Oxygen uptake rate (mg O2.g-1.h-1) |
Inhibition (%) |
Control (1) |
0 |
29.650 |
- |
Control (2) |
0 |
30.849 |
- |
Ref (1) |
5.00 |
27.821 |
9.770 |
Ref (2) |
8.40 |
28.299 |
8.219 |
Ref (3) |
14.20 |
14.357 |
53.436 |
Ref (4) |
23.80 |
7.021 |
77.228 |
Ref (5) |
40.00 |
4.677 |
84.833 |
Test item |
10.72 |
33.351 |
-8.167 |
Test item |
11.22 |
28.027 |
9.100 |
Test item |
33.72 |
28.956 |
6.089 |
Test item |
100.08 |
26.584 |
13.781 |
Test item |
101.02 |
25.140 |
18.463 |
Test item |
320.66 |
28.485 |
7.617 |
Test item |
999.2 |
26.589 |
13.764 |
Test item |
1001.92 |
24.106 |
21.817 |
Control (3) |
0 |
34.645 |
- |
Control (4) |
0 |
28.190 |
- |
Table 6.1.7/3: Definitive test results (oxygen uptake rate, inhibition, and pH at the end of the test)
Content |
Concentration (mg.L-1) |
Oxygen uptake rate (mg O2.g-1.h-1) |
Inhibition (%) |
pH |
Control (1) |
0 |
26.247 |
- |
7.950 |
Control (2) |
0 |
26.755 |
- |
7.944 |
Ref (1) |
5.00 |
23.763 |
17.389 |
7.887 |
Ref (2) |
8.40 |
19.932 |
30.708 |
7.844 |
Ref (3) |
14.20 |
10.413 |
63.799 |
8.018 |
Ref (4) |
23.80 |
5.105 |
82.252 |
8.048 |
Ref (5) |
40.00 |
3.691 |
87.169 |
8.097 |
Control (3) |
0 |
27.985 |
- |
7.966 |
Control (4) |
0 |
28.394 |
- |
7.917 |
Test item |
10.28 |
26.471 |
7.975 |
7.945 |
Test item |
11.96 |
28.832 |
-0.233 |
7.876 |
Test item |
11.02 |
30.270 |
-5.233 |
7.782 |
Test item |
10.54 |
29.438 |
-2.338 |
7.889 |
Test item |
11.34 |
29.357 |
-2.057 |
7.946 |
Test item |
100.16 |
26.080 |
9.333 |
7.976 |
Test item |
100.50 |
24.509 |
14.795 |
8.066 |
Test item |
101.44 |
24.868 |
13.546 |
8.055 |
Test item |
101.16 |
24.641 |
14.337 |
8.080 |
Test item |
101.44 |
n.d.* |
n.d. |
7.756 |
Test item |
1000.12 |
32.743 |
-13.831 |
7.728 |
Test item |
1001.86 |
23.468 |
18.414 |
7.781 |
Test item |
1000.04 |
25.602 |
10.996 |
7.737 |
Test item |
999.94 |
23.852 |
17.078 |
7.760 |
Test item |
1000.18 |
24.368 |
15.286 |
7.754 |
Control (5) |
0 |
29.693 |
- |
7.984 |
Control (6) |
0 |
33.519 |
- |
7.808 |
Description of key information
OECD Guideline 209, EU Method C.11, GLP, Key study, validity 1:
3h-EC50 (activated sludge) > 1000 mg/L based on nominal concentrations.
3h-NOEC (activated sludge) = 10 mg/L based on nominal concentrations.
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 10 mg/L
Additional information
One key study is available to assess the toxicity of the registered substance to microorganisms.
This study (LPL, 2020) was performed according to OECD Guideline 209 and EU Method C.11 with GLP compliance. Following a preliminary range-finding test, microorganisms from activated sludge were exposed to the registered substance at nominal concentrations of 10, 100 and 1000 mg/L (five replicates for each concentration) and to six blank controls in order to determine a concentration with no significant effect and to demonstrate that EC50 was higher than 1000 mg/L. After 3 hours of exposure, a slight effect on the respiration rate of activated sludge was observed at 100 and 1000 mg/L (average inhibition of 13.0 and 9.6%, respectively). No effect on the respiration rate was observed at 10 mg/L. Therefore, under the experimental conditions and based on nominal concentrations, the 3h-EC50 value was estimated to be higher than 1000 mg/L and the NOEC value was determined at 10 mg/L.
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.