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EC number: 241-620-3 | CAS number: 17636-10-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- 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:
- Sodium 2-Mercaptoethane Sulfonate Protection against Cyclophosphamide-Induced Teratogenicity in Rats
- Author:
- Slott, V.L., Hales, B.F.
- Year:
- 1 986
- Bibliographic source:
- Toxicology and applied pharmacology: 82,80-86 (1986)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pregnant Sprague-Dawley rats were divided into nine treatment groups. Individual groups were administered 0.9% NaCl or cyclophosphamide (10 or 15 mg/kg) alone or in combination with MESNA at one of two doses (5 or 30 mg/kg), or MESNA alone on Day 13 of gestation.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Mesna
- EC Number:
- 243-285-9
- EC Name:
- Mesna
- Cas Number:
- 19767-45-4
- IUPAC Name:
- sodium 2-sulfanylethanesulfonate
- Test material form:
- other: as solution in 0.9 % NaCl
- Details on test material:
- - Name of test material (as cited in study report): MESNA (in the form of sodium salt)
- Molecular formula (if other than submission substance): C2H5NaO3S2
- Molecular weight (if other than submission substance): 164.18
- Smiles notation (if other than submission substance): C(S)CCS(=O)(=O)O{-}.[Na]{+}
- InChl (if other than submission substance): 1S/C2H6O3S2.Na/c3-7(4,5)2-1-6;/h6H,1-2H2,(H,3,4,5);/q;+1/p-1
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: organosulphur compound
- Physical state: pulver (Sigma Aldrich)
- Analytical purity: 98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Canada Inc. (St. Constant, Quebec).
- Weight at study initiation: 225-250 g
- Housing: McIntyra Animal Center (McGill University, Montreal, Quebec)
- Diet (e.g. ad libitum): ad libitum (Purina Rat chow)
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Details on exposure:
- MESNA or 0.9% NaCl was injected intravenously via jugular vein immediately followed by an ip dose of cyclophosphamide or 0.9% NaCl.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Duration of treatment / exposure:
- single injection
- Frequency of treatment:
- single treatment on day 13 of gestation
- Duration of test:
- 20 Days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5 and 30 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 7 (65 animals were divided into nine treatment groups)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: the MESNA doses of 5 and 30 mg/ kg were chosen to achieve ratios of MESNA to cyclophosphamide on a milligram per kilogram basis of I:3 (5 m/kg MESNA, 15 mg/kg cyclophosphamide; optimal for protection against urotoxicity) and 3: 1 (30 mg/kg MESNA, 10 mg/kg cyclophosphamide).
Examinations
- Maternal examinations:
- POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: not reported - Ovaries and uterine content:
- No data
- Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [all per litter]
- Head examinations: Yes: [all per litter] - Statistics:
- Teratogenicity data were analysed with the fetus as the experimental unit by x² test with Yate's correction for discontinuity. The fetal weight data were analysed by one-way analysis of variance. The level of significance for all tests was taken as p<=0.05 unless stated otherwise. These procedures are described by Snedecor and Cochran (1967).
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:not examined
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Mesna did not induce teratogenic effects in pups of rats until 30 mg/kg bw.
- Executive summary:
The teratogenicity potential of MESNA could be evaluated from the results of a teratogenicity study conducted with cyclophosphamide known anti-cancer drug (Slott and Hales, 1986). The study was designed to determine whether the teratogenic effects of cyclophosphamide and its metabolites could be prevented by MESNA. On day 13 of gestation, pregnant Spague Dawley rats were administered MESNA intravenously at one of two dose levels (5 and 30 mg/kg bw) in combination with cyclophosphamide or alone. Vehicle control group included animals treated with 0.9% NaCl. Rats were killed on day 20 of gestation and fetuses were examined for gross external malformations, fetal body weight, and skeletal defects. The administration of MESNA alone had no significant effects on the incidence of malformations compared to vehicle control (2/62 malformed fetuses in 5 mg/kg bw group and 0/62 malformed fetuses in 30 mg/kg bw dose group). The administartion of MESNA had no sigificant effects on the incidence of dead or resorbed fetuses (similar to vehicle control). No effects of MESNA treatments were observed on fetal body weights. No skeletal malformations were recorded for MESNA treatment groups. MESNA significantly decreased a certain number of fetal malformations induced by cyclophosphamide administration confirming its protective effects against the teratogenic effects of cyclophosphamide.
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