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EC number: 617-116-8 | CAS number: 80573-04-2
- 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

Endpoint summary
Administrative data
Description of key information
The acute oral toxicity studies show that Balsalazide disodium and hence balsalazide acid are not toxic when administered to rats as a single oral dose of 2000 and 5000 mg/kg bw. No mortalities, adverse effects or clinical signs were observed during the studies. Therefore, the highest doses tested were considered to be the non-lethal doses and the LD50 in rats is considered to be greater than 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is specified in the report.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methylcellulose or 0.9% NaCl
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- All animals were observed for clinical signs and mortality for 7 days. At the end of the observation period, all animals were sacrificed and subjected to complete necropsy.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed during the test.
- Clinical signs:
- other: No clinical signs were observed during the test.
- Conclusions:
- The acute oral non-lethal dose in rats was greater than 2000 mg/kg.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is specified in the report.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD (SD) BR
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methylcellulose or 0.9% NaCl
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 3 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- All animals were observed for clinical signs and mortality for 7 days. At the end of the observation period, all animals were sacrificed and subjected to complete necropsy.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed during the test.
- Clinical signs:
- other: No clinical signs were observed during the test.
- Conclusions:
- The acute oral non-lethal dose in rats was greater than 5000 mg/kg.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No mortalities, adverse effects or clinical signs were observed during the acute oral toxicity studies. Therefore, the highest doses tested were considered to the non-lethal doses and the LD50 is greater than 2000 mg/kg bw and is therefore above the dose required for classification.
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