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Diss Factsheets
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EC number: 419-800-1 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 419-800-1
- EC Name:
- -
- Cas Number:
- 112101-81-2
- Molecular formula:
- C10H16N2O3S
- IUPAC Name:
- (R)-5-(2-Aminopropyl)-2-methoxybenzenesulfonamide
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl: CD.BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Five to seven weeks old
- Weight at study initiation: Males 163 to 188 g and females 145 to 162 g
- Fasting period before study: Yes (18 hours prior to dosing until 3 hours after dosing).
- Housing: Up to 5 rats of the same sex were accommodated in suspended stainless steel mesh cages.
- Diet (e.g. ad libitum): SQC(E) rat and mouse maintenance diet No. 1 was freely available to the animals at all times except for a period of fasting.
- Water (e.g. ad libitum): Mains water was provided ad libitum via cage mounted water bottles.
- Acclimation period: At least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 40 to 70% relative humidity
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: standard vehicle
MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
DOSAGE PREPARATION (if unusual): The test article was dispersed in corn oil and all formulations were used on the day of preparation. - Doses:
- Preliminary test: 500 and 2000 mg/kg
Main test: 2000 mg/kg - No. of animals per sex per dose:
- Five males and five females in the main phase
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were noted once within 30 minutes of dosing, four times within the first 4 hours of dosing, twice daily on days 2, 3 and 4 then once daily from the 5th onwards. Bodyweights were recorded on day -1, Day 1, 8 and 15.
- Necropsy of survivors performed: yes. The necropsy procedure included inspection of external thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines.
- Other examinations performed: - Statistics:
- Not required
Results and discussion
- Preliminary study:
- Groups of one fasted female rat dosed at 500 or 1000 mg/kg/day. All animals survived.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died following a single oral dose.
- Clinical signs:
- other: Two males were lethargic approximately four hours after dosing on Day 1 but this had resolved by day 2. Staining of teh snout was apparent in all rats during Day 2 and the female rats also showed soiling of the anogenital region.
- Gross pathology:
- Necropsy at termination revealed enlargement or red foci on the mandibular lymph nodes of 5 rats, reddening of the thymus in two rats and single cases of a small uterus or renal pelvic dilatation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal oral dose of the test substance to rats was found to exceed 2000 mg/kg (the standard limit dose for such studies).
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