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EC number: 611-915-5 | CAS number: 59941-98-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- other: "Acute Oral Toxicity - Acute Toxic Class method" JMAFF Guidelines
- Version / remarks:
- 2000, inclusing the most recent partial revisions
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- N-{4-[(4,6-dimethylpyrimidin-2-yl)sulfamoyl]phenyl}-2-methylprop-2-enamide
- EC Number:
- 611-915-5
- Cas Number:
- 59941-98-9
- Molecular formula:
- C16 H18 N4 O3 S
- IUPAC Name:
- N-{4-[(4,6-dimethylpyrimidin-2-yl)sulfamoyl]phenyl}-2-methylprop-2-enamide
- Test material form:
- solid: particulate/powder
- Remarks:
- determined at NOTOX
- Details on test material:
- pH 6.4 (determined at NOTOX)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age and body weight: Young adult animals (approx. 11 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Earmark.
Health inspection A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of
health.
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +- 3.0°C (actual range: 20.7-22.4°C), a relative humidity of 30-70% (actual range: 34% - 61%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation
Group housing of 3 animals per cage in labelled lvlacrolon cages (MIV type; height 18 cm.) containing sterilised sawdust as bedding material (Woody-Clean type 3/4, Tecnilab-BMI BV, Someren, The Netherlands) and paper as cage-enrichment (Enviro-dri, Tecnilab-BlVll BV, Someren, The Netherlands).
Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage,
Germany).
Water
Free access to tap water.
Results of analysis for each batch of diet (nutrients) and results of quarterly analysis of diet (contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Source: Genfarma, Zaandam, The Netherlands
- Details on oral exposure:
- Use of stainless steel stomach tube
Food was witheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of test substance - Doses:
- Single dosage of 2000 mg/kg bodyweight (10 ml/kg) on day 1
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no
- Clinical signs:
- other: Hunched posture was noted among the majority of animals between days 1 and 3.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals,
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of v123109 in Wistar rats was established to exceed 2000 mg/kg body weight,
Based on these results v123109 does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (New York and Geneva, 2003) and EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC)"
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