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EC number: 293-878-1 | CAS number: 91648-19-0
- 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:
- 25th May to 27th July 1995
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- EC Number:
- 293-878-1
- EC Name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- Cas Number:
- 91648-19-0
- IUPAC Name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Betadet SHR
Lot number: 7049
Appearance: viscous yellowish liquid
pH: 7.48
Storage: Room temperature; protected from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight on arrival: 80-95g
Age on arrival: Approximately 4 weeks
Source: Charles River, supplied by Criffa, S.A
Housing: Makrolon cages with sawdust bedding, up to 5 rats of same sex
Acclimatisation period: At least 5 days
Weight at start of study: 100g (preliminary study); 107-122g (main study)
Temperature: 19-26 degrees C
Humidity: 32-86% (generally within 40-70%)
Photoperiod: 12 hours light/dark cycle
Diet: Standard rat diet UAR A04C, ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, S.A; ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- In the preliminary study, one female was dosed with 2000 mg/kg bw .In the main study, five males and five females were dosed with 2000 mg/kg bw. Animals were fasted 18 hour prior to treatment. The test substance was administered orally by gastric intubation using a metal catheter. The solutions were prepared immediately prior to dosing. A single dose was given at a volume of 10 mL/kg bw. The quantity was based on bodyweight at the time of dosing. Food was replaced three hours following dosing.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five (additional female used in preliminary study).
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- The rats were observed at least twice daily for 7 days (preliminary study) or for 14 days (main study), after which they were sacrificed. Observations included changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, central and autonomous systems, somatomotor activity and behaviour patterns.
Body weights were recorded before administration, daily for the first three days, then weekly and prior to being sacrificed. Rats were sacrificed by carbon dioxide inhalation. The animals in the main study were subjected to necropsy. The necropsy included a revision of the intact animal and its superficial tissues, followed by observation of the cranial, thoracic and abdominal cavities in situ and after evisceration.
Results and discussion
- Preliminary study:
- No mortality was observed. The female presented soft faeces on the day following treatment. No other clinical signs were noted. The animal showed normal body growth.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No deaths occurred at the limit dose of 2000 mg/kg bw
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: Slightly soft faeces were noticeable on the day following treatment. No other clinical signs were noted.
- Gross pathology:
- No visible macroscopic lesions were noted which were treatment related.
Any other information on results incl. tables
No deaths occurred at the limit dose of 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No deaths were observed in this study at the limit dose of 2000 mg/kg bw. Slightly soft faeces were noticeable on the day following treatment. No other clinical signs were noted. The substance is not classified for acute oral toxicity under CLP.
- Executive summary:
An acute oral toxicity study with Betadet SHR was conducted using a fixed dose method. Wistar rats were dosed with 2000 mg/kg bw. A preliminary experiment comprising one female showed no mortality. Soft faeces were noted on the day following treatment. No other clinical signs were noted during the seven day observation period. A main experiment comprised five animals/sex. Soft faeces were noted on the day following treatment. There were no other clinical signs, mortality or post mortem observations. Body weight gain was normal. The overall conclusion of the study was that the test material showed no significant signs of toxicity. The substance is not classified for acute oral toxicity under CLP.
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