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EC number: 619-946-6 | CAS number: 890707-29-6
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2009 - November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Cas Number:
- 890707-29-6
- Molecular formula:
- C10H11N3O
- IUPAC Name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
Hydrolysis samples were collected from each pH after the test solution was placed into the test vessels (0 hour) and at 2 hour, 5 hour, Day 1 and Day 5.
- Sampling intervals/times for pH measurements:
The pH of the buffer solutions were measured after preparation and sterile filtration. The pH was also documented after sample fortification of pH 4, 7 and 9 buffer test solution on Day 0 and Day 5.
- Sampling intervals/times for sterility check:
Sterility was determined at Day 0 for sterile pH 4, 7 and 9 buffer test systems and at day 5 for pH 4, 7 and 9 buffer test system.
- Sample storage conditions before analysis:
All test samples were analyzed on the same day of sampling and stored at -20±1°C until the completion of the entire study. - Buffers:
- - pH: 4
- Composition of 0.01 M pH 4 buffer: sodium acetate, acetic acid, final pH adjustments with sodium hydroxide
- pH: 7
- Composition of 0.01 M pH 7 buffer: sodium phosphate (monobasic), sodium phosphate (dibasic), final pH adjustments with sodium hydroxide
- pH: 9
- Composition of 0.01 M pH 9 buffer: boric acid, final pH adjustments with sodium hydroxide
After preparation, the buffer solutions were filtered by passing through a 0.2 μm filter. The pH was verified following sterilization. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 4 mL amber vials with screw caps
- Sterilisation method: 20 minutes at 121°C
- Lighting: Complete darkness
- If no traps were used, is the test system closed/open: Closed system
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No
TEST MEDIUM
- Volume used/treatment: 4.0 mL sterile buffer fortified with test substance at a concentration of 25 mg/L
- Kind and purity of water: Deionized water
- Preparation of test medium:
- Renewal of test solution: No renewal
- Identity and concentration of co-solvent: Acetonitrile, 0.5%
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 21.96 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 23.72 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 24.97 mg/L
- Number of replicates:
- Preliminary test: 2 replicates per test system
Results and discussion
- Preliminary study:
- The preliminary test for hydrolysis of the test substance was conducted at 50 ± 0.5°C in the dark at each of pH 4, 7 and 9 buffer solutions for a period of 5 days.
Analysis of pH 4, 7 and 9 buffer solutions at Day 5 showed >90% of the recovered test item compared to the 0 Hour analysis.
Thus the test substance was considered to be hydrolytically stable. - Test performance:
- Due to the results of the preliminary test no further tests were conducted.
- Transformation products:
- no
Total recovery of test substance (in %)open allclose all
- % Recovery:
- > 90
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- > 90
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- > 90
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
Dissipation DT50 of parent compound
- Key result
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Results obtained in preliminary test clearly indicate that the test submstance was stable over a period of 5 days at 50 ± 5°C which would indicate a DT50 of >1 year at 25°C.
- Executive summary:
The present study was conducted to determine the hydrolytic stability of the test substance according to OECD guideline 111 and EEC method C.7.
The preliminary test for hydrolysis of the test substance was conducted at 50 ± 0.5°C in the dark at each of pH 4, 7 and 9 buffer solutions for a period of 5 days.
Based on the preliminary test data generated in this study, the test substance was found hydrolytically stable in pH 4, 7 and 9 buffers at 50 ± 0.5°C.
The results of the preliminary study are summarized below:
1. Analysis of pH 4 buffer solution at Day 5 showed >90% of the recovered test item compared to the 0 Hour analysis.
2. Analysis of pH 7 buffer solution at Day 5 showed >90% of the recovered test item compared to the 0 Hour analysis.
3. Analysis of pH 9 buffer solution showed >90% of the recovered test item compared to the 0 Hour analysis.
Results obtained in preliminary test clearly indicate that the test substance was stable over a period of 5 days at 50 ± 5°C which would indicate a DT50 of >1 year at 25°C.
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