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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-465-2 | CAS number: 8047-99-2
- 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
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Dec 2017 - 12 Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- March 04, 2016
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- April 13, 2004
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Version / remarks:
- October 2008
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method and interval:
The concentration of the test item in the test samples was determined immediately after preparation (t=0) and after 5 days. The samples taken at t=5 days were cooled to room temperature using running tap water. Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analyzed at t=0.
Analysis was performed on subsamples of 700 µL. The samples were diluted in a 7:3 (v:v) ratio with acetonitrile and analyzed.
Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analyzed at t=0.
- Sampling intervals/times for pH measurements: The pH of each of the test solutions (except for the blanks) was determined at each sampling time. - Buffers:
- BUFFER SOLUTIONS
Acetate buffer pH 4, 0.1:
solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. Buffer contained 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.1 M:
Solution of 0.1 M potassium di-hydrogen-phosphate in water adjusted to pH 7 using 1N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.1 M:
Solution of 0.1 M boric acid in water and 0.1 M potassium chloride in water adjusted to pH 9 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide. - Details on test conditions:
- TEST SYSTEM
- Sterilisation method: The buffer solutions were filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel.
- Measures taken to avoid photolytic effects: sterile vessels under vacuum were placed in the dark
- Measures to exclude oxygen: To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes.
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No
TEST MEDIUM
- The test item was spiked to the solutions at a target concentration of 20 mg/L using a spiking solution in acetonitrile. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in the dark in a temperature controlled environment at 49.9°C +/- 0.1°C.
- Volume used/treatment: The spiking volume was ≤ 1% of the sample volume. Nominal concentrations were not corrected for the spiking volume.
- Kind and purity of water: Tap water purified by a Milli-Q water purification system (Millipore, Bedford, MA, USA)
- Preparation of test medium: M2; according to the OECD 201 Guideline, formulated using Milli-RO water and with the following composition:
NH4Cl 15 mg/L
MgCl2.6H2O 12 mg/L
CaCl2.2H20 18 mg/L
MgSO4.7H2O 15 mg/L
KH2PO 41.6 mg/L
FeCl3.6H2O 64 µg/L
Na2EDTA.2H2O 100 µg/L
H3BO3 185 µg/L
MnCl2.4H2O 415 µg/L
ZnCl2 3 µg/L
CoCl2.6H2O 1.5 µg/L
CuCl2.2H2O 0.01 µg/L
Na2MoO4.2H2O 7 µg/L
NaHCO3 50 mg/L
- Identity and concentration of co-solvent: The samples were diluted in a 7:3 (v:v) ratio with acetonitrile and analyzed. - Duration:
- 5 d
- pH:
- 4.1
- Temp.:
- 50 °C
- Initial conc. measured:
- 20.1 mg/L
- Remarks:
- 49.9 +/- 0.1 °C
- Duration:
- 5 d
- pH:
- 7.1
- Temp.:
- 50 °C
- Initial conc. measured:
- >= 20.1 - <= 20.2 mg/L
- Remarks:
- 49.9 +/- 0.1 °C
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 20.2 mg/L
- Remarks:
- 49.9 +/- 0.1 °C
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- At pH 4, pH 7 and pH 9, a degree of hydrolysis of < 10% was observed after 5 days. It demonstrated that the half-life time of the test item at 25°C is > 1 year. According to the guideline, no further tests were required. No test item was detected in the blank buffer solutions. The mean recoveries of the of the test item containing buffer solutions at t=0 fell within the criterion range of 90-110%. It demonstrated that the analytical method was adequate to support the hydrolysis study on the test item.
- Test performance:
- The analytical method was validated for the analysis of N-ethyl-o (or p) toluenesulphonamide in M2-medium for the following parameters:
• Specificity: One major peak was observed in the chromatograms of the QC samples. The peak area of this peak was used as response in the calculationsThe chromatogram of the blank QC sample showed no peak at the retention time of the test item. Since no interferences were detected, the specificity requirements were met and the analytical method was found to be specific for the test item.
• Calibration curve: There was a linear relationship between response and test item concentration in the range of 0.0500 – 20.0 mg/L (in end solution). Since the coefficient of correlation (r) was > 0.99 and the back calculated accuracies of the data points were in the range 85-115% the calibration line was accepted.
• Accuracy and Repeatability: Since the mean accuracy at each concentration level fell in the criterion 70-110% and the coefficient of variation was ≤ 20% the analytical method was accepted for the analysis of the test item in M2-medium in the target concentration range of 0.100 - 100 mg/L.
• Limit of quantification: The limit of quantification (LOQ) was assessed at 0.1 mg/L in M2-medium.
• Stability analytical system and end solutions: Since the coefficient of variation at both concentration levels was ≤ 20% the analytical system and end solutions were stable over at least a 19.32 hour time interval.
• Stability stock solutions: The coefficient of variation on the response factors of the calibration solutions prepared with fresh and stored stock solutions was 1.9%. Since the value was ≤ 10% the stock solutions were stable when stored at room temperature for at least 4 days.
• Storage stability of samples: The mean accuracy of the frozen QC samples fell in the criterion 70-110% the samples were stable when stored in the freezer (≤ -15°C). - Transformation products:
- no
- Remarks:
- no decrease of initial concentration was measured
- % Recovery:
- 100
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- other: The mean recoveries of the test item containing buffer solutions were measured at t=0
- % Recovery:
- ca. 100
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- other: The mean recoveries of the test item containing buffer solutions were measured at t=0 and were concluded 101%
- % Recovery:
- ca. 100
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- other: The mean recoveries of the test item containing buffer solutions were measured at t=0 and were concluded 101%
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Validity criteria fulfilled:
- yes
- Conclusions:
- The preliminary test (Tier 1) was performed for the determination of the rate of hydrolysis of N-ethyl-o (or p) toluenesulphonamide at pH values normally found in the environment (pH 4-9). At each pH value a degree of hydrolysis of < 10% was observed after 5 days. According to the guideline, performance of the main study (Tier 2) was not required. The chemical was considered hydrolytically stable.
- Executive summary:
A preliminary test (Tier 1) was performed to determine the rate of hydrolysis of N-ethyl-o (or p) toluenesulphonamide at pH values normally found in the environment (pH 4-9).The study was conducted according to OECD 111 and GLP guidelines. In addition analytical methods were validated prior to the test. Sterile aqueous buffer solutions of pH values of 4, 7 and 9 were treated with the test substance and incubated in the dark under controlled laboratory conditions at a temperature of 49 ± 1°C. Quantative analysis was performed using an ultra performance liquid chromatographic method with spectrophotometric detection (UPLC-UV) and measured immediately after preparation (t=0) and after 5 days. At each pH value a degree of hydrolysis of < 10% was observed after 5 days. According to the guideline, performance of the main study (Tier 2) was not required. A hydrolysis half-life of > 1 year for all pH at 25°C was determined for the test substance. The chemical is considered hydrolytically stable.
Reference
Hydrolysis of the Test Item at pH 4, pH 7 and pH 9
pH code |
Sampling time |
Analyzed concentration |
Degree of hydrolysis |
pH |
|
Individual |
Mean |
||||
pH 4 |
0 hours |
20.1 |
|
|
4.1 |
|
|
20.1 |
|
|
4.1 |
|
5 days |
20.7 |
-3.2 |
-2.4 |
4.1 |
|
|
20.4 |
-1.6 |
|
4.1 |
pH 7 |
0 hours |
20.2 |
|
|
7.1 |
|
|
20.1 |
|
|
7.1 |
|
5 days |
20.4 |
-1.3 |
-1.4 |
7.1 |
|
|
20.5 |
-1.6 |
|
7.1 |
pH 9 |
0 hours |
20.2 |
|
|
9.0 |
|
|
20.2 |
|
|
9.0 |
|
5 days |
20.6 |
-2.2 |
-2.2 |
9.0 |
|
|
20.6 |
-2.3 |
|
9.0 |
Recoveries
pH code |
Nominal concentration |
Analyzed concentration |
Recovery |
|
Individual |
Mean |
|||
pH 4 |
20.0 |
20.1 |
100 |
100 |
|
20.0 |
20.1 |
100 |
|
pH 7 |
20.0 |
20.2 |
101 |
101 |
|
20.0 |
20.1 |
101 |
|
pH 9 |
20.0 |
20.2 |
101 |
101 |
|
20.0 |
20.2 |
101 |
|
Description of key information
Hydrolysis: the substance is hydrolytically stable as shown from a OECDTG111 guideline study:
Hydrolysis as a function of pH |
EC C.7 |
pH 4: t½> 1 year |
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 50 °C
Additional information
The half-life is > 1 year for all pH's tested
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.