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EC number: 248-324-3 | CAS number: 27206-35-5
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- mechanistic studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the Urotoxicity of Oxazaphosphorine Cytostatics and its Prevention. 2. Comparative Study on the Uroprotective Efficacy of Thiols and Other Sulfur Compounds
- Author:
- Brock, N., Pohl, J., Stekar, J.
- Year:
- 1 981
- Bibliographic source:
- Eur J. Cancer Clin. Oncol., Vol. 17, No. 11, pp, 1155-1163, 1981.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sodium-3-mercapto-propane sulfonate (Asta 7100 = MPS) was tested for its uroprotective action in 5 (per dose level) Sprague Dawley rats treated with 68 mg/kg ifosfamide that is known to induce haemorrhagic cystitis. MPS was administered by i. v. administration 15 min before the injection of ifosfamide at dose levels of 21.5, 68.1 and 215 mg/kg bw. The uroprotective efficacy of MPS was evaluated 24 hours after the administration of ifosfamide. The rats were killed and the urinary bladder were evaluated (inflammation, bleeding and weight).
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- basic toxicokinetics
Test material
- Reference substance name:
- Sodium 3-mercaptopropanesulphonate
- EC Number:
- 241-620-3
- EC Name:
- Sodium 3-mercaptopropanesulphonate
- Cas Number:
- 17636-10-1
- Molecular formula:
- C3H8O3S2.Na
- IUPAC Name:
- sodium 3-sulfanylpropane-1-sulfonate
- Test material form:
- other: i.v. solution
- Details on test material:
- - Name of test material (as cited in study report): sodium-3-mercapto-propane sulfonate (Asta 7100) (Asta Werke, Bielefeld, Germany)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke, Bielefeld, and Mus Rattus AG, Brunnthal
- Weight at study initiation: 250 g
- Housing: standard conditions
- Diet (e.g. ad libitum): ad libitum (altromin ® 1324, no deprivation)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS: not reported
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Details on exposure:
- No details reported
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- single treatment
- Frequency of treatment:
- single treatment
- Post exposure period:
- 24 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
screening dose: 100 mg/kg bw; 21.5, 68.1 and 215 mg/kg bw
Basis:
other: nominal dose
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- No details
Examinations
- Examinations:
- Urinary bladder weight; gross pathology (inflammation, bleeding).
- Positive control:
- Ifosfamide (68 mg/kg bw)
Results and discussion
- Details on results:
- Asta 7100 exerted a uroprotective effect at doses of 100 mg/kg bw and 215 mg/kg bw. The uroprotective efficacy of MPS was lesser than that of its short-chain homologue mesna.
Any other information on results incl. tables
The severity of the inflammation of the bladder after i.v. administration of ifosfamide was dose-dependent. An ifosfamide dose of 68 mg/kg always induced an approximately 2- fold increase in the wet weight of the bladder and a damage score of about 2. Some of the rats also showed bladder haemorrhages. The scoring system used takes into account two parameters: firstly, increased capillary permeability (which is demonstrable objectively by the extravasal occurrence of intravenously injected trypan blue) and secondly, the increase in the weight of the bladder, which can also be assessed macroscopically as a swelling of the bladder. In some selected groups the bladder damage and the extent of bladder protection were also investigated histologically. The uroprotective effect of MPS was dose-dependent. It was reflected in a reduced increase in the bladder weight and reduced extravasation of trypan blue, and it was also demonstrable histologically. In the case of the test compounds with a demonstrable uroprotective effect (i.e. mesna) the lowest dose ensuring reliable uroprotection was determined. The results of these investigations of the uroprotective efficacy of MPS and mesna (as well as it dimer dimesna) are summarized in the following table:
Table 1. Uroprotective action of mercapto-alkane sulfonates and analogs | |||||||||
Assessment of urinary bladder | |||||||||
Compound | Structural formula | Dose (mg/kg) | Animals (n) | Inflamm. (x/n) | Bleeding | Weight (mg) | Score (0-3) | ||
x/n | Mean + SE |
||||||||
Untreated controls | — | 105 | 0 | 0 | 81.0±12.0 | 0 | |||
Ifosfamide | 68.1 | i.v. | 100 | 100 | 63 | 165.0±35.0 | 2.3 | ||
Mesna | HS-CH2-CH2-SO3Na | 6.81 | i.v. | 10 | 6 | 1 | 97.3±22.6 | 1.5 | |
10.0 | i.v. | 10 | 2 | 0 | 88.8±5.4 | 0.5 | |||
14.7 | i.v. | 10 | 0 | 0 | 77.5±10.9 | 0.3 | |||
21.5 | i.v. | 10 | 0 | 0 | 72.6±10.3 | 0 | |||
Dimesna | S-CH2CH2-S03Na S-CH2CH2-S03Na |
21.5 | i.v. | 10 | 6 | 3 | 137.5±29.1 | 1.4 | |
31.6 | i.v. | 10 | 3 | 0 | 101.6±12.4 | 0.3 | |||
46.4 | i.v. | 10 | 1 | 0 | 86.6±12.4 | 0.1 | |||
68.1 | i.v. | 10 | 0 | 0 | 77.5±10.9 | 0 | |||
Asta 7100 | HS-(CH2)3-SO3Na | 21.5 | i.v. | 5 | 5 | 0 | 138.4±26.5 | 2.0 | |
68.1 | i.v. | 5 | 3 | 0 | 80.4±7.4 | 0.5 | |||
215.0 | i.v. | 5 | 1 | 0 | 77.0±10.1 | 0.1 |
Applicant's summary and conclusion
- Conclusions:
- MPS possesses uroprotective efficacy against ifosfamide induced haemorrhagic cystitis in rats at dose levels of 100 and 215 mg/kg bw.
- Executive summary:
Sodium-3-mercapto-propane sulfonate (Asta 7100 = MPS) was tested for its uroprotective efficacy in 5 Sprague Dawley rats treated with 68 mg/kg ifosfamide that is known to induce haemorrhagic cystitis. MPS was administered by i. v. administration 15 min before the injection of ifosfamide at the screening dose of 100 mg/kg bw and thereafter was raised or lowered in steps with a factor of 2.15. The dose levels were 21.5, 68.1 and 215 mg/kg bw. The uroprotective efficacy of MPS was evaluated 24 hours after the administration of ifosfamide. The rats were killed and the urinary bladder was evaluated (inflammation, bleeding and weight). The severity of the inflammation of the bladder after i.v. administration of ifosfamide was dose-dependent. An ifosfamide dose of 68 mg/kg always induced an approximately 2- fold increase in the wet weight of the bladder and a damage score of about 2. Some of the rats also showed bladder haemorrhages. The scoring system used takes into account two parameters: firstly, increased capillary permeability (which is demonstrable objectively by the extravasal occurrence of intravenously injected trypan blue) and secondly, the increase in the weight of the bladder, which can also be assessed macroscopically as a swelling of the bladder. In some selected groups the bladder damage and the extent of bladder protection were also investigated histologically. The uroprotective effect of MPS was dose-dependent. It was reflected in a reduced increase in the bladder weight and a reduced extravasation of trypan blue, and it was also demonstrable histologically. MPS exerted its uroprotective effect at doses of 100 and 215 mg/kg bw. MPS was, however, less effective than its short-chain homologue mesna (CAS 19767-45-4).
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