Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- 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:
- Reproductive Toxic Effects of Cisplatin and Its Modulation by the Antioxidant Sodium 2-Mercaptoethanesulfonate (Mesna) in Female Rats
- Author:
- Yeh J., Beom Su Kim, Peresie, J.
- Year:
- 2 011
- Bibliographic source:
- Reproductive Biology Insights 2011:5 17–27
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Adult female rats were injected with saline, cisplatin alone, mesna alone (200 mg/kg bw), mesna + saline or mesna + cisplatin, mated with males. The animals were given two i.p. injections one week apart, (mesna 30 minute pretreatment with saline or cisplatin) followed by mating up to ten days after treatment. The animals were euthanized on gestational day 17 and the number corpora lutea, implantation and resorption sites, viable and non-viable fetuses, fetal weights, and the level of progesterone per corpus luteum were determined.
- GLP compliance:
- no
- Type of method:
- other: fertility
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: i.p. infusion
- Details on test material:
- - Name of test material (as cited in study report): Mesna
- 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
- Substance type: organosulphur compound
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: Harlan (Indianapolis, IN)
- Age at study initiation: 65-75 days
- Housing: the females were housed with proven male breeders in ratios of 3 females to one male.
- Acclimation period: one week
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): i.p. injections were prepared in saline - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- two weeks
- Frequency of treatment:
- two injections one week apart
- Duration of test:
- Two weeks (treatments once a week) following by mating period up to ten days (no treatment) and 17 days of gestation (no treatment).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- Not reported
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The female rats used in this study were divided into two groups. Group 1 served as the cisplatin mating group and group 2 served as the mesna + cisplatin mating group. The rats in the group 2 (relevant here) were divided into four sub-groups, the control (saline) sub-group, the mesna + saline control subgroup, mesna + cisplatin treatment sub-group, and cisplatin only treatment sub-group. Cisplatin was given at a dosage of 4.5 mg/kg. Mesna was given as a 200 mg/kg dosage 30 minutes prior to the administration of saline or cisplatin. Each rat also received 10 mL of sterile 0.9% NaCl SQ over multiple injection sites following the administration of cisplatin and as needed throughout the course of the study to prevent dehydration. Animals were monitored and weighed daily.
- Statistics:
- All data are presented as mean +/− standard error of the mean (SEM). Experiments were performed at least three times and the results are presented as the combined data from all experiments. The students’ t test was used to determine statistical difference between the saline and cisplatin groups from the Experiment 1 mating studies. For the Experiment 2 mesna + cisplatin mating studies, analysis of variation (ANOVA) followed by linear trend contrast was used to determine statistical difference. All statistical calculations were carried out using SPSS for Windows, version 11.0. A P < 0.05 was considered statistically different.
Results and discussion
Effect levels
- Dose descriptor:
- dose level:
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The administration of mesna + saline did not affect any of the reproductive outcomes compared to the saline control. Mesna protected against cisplatin induced reproductive toxicity.
Observed effects
Cisplatin caused a decrease in the percentage of females that mated to males but there was no change in the fecundity index in the animals treated with cisplatin alone and in the saline control animals. Cisplatin treated animals had an increase in the number of resorption sites and the presence of a non-viable fetus as well as an increase in the percentage of pre-implantation and post-implantation losses in comparison to the control animals. The total number of resorptions per pregnant animal was increased. There was a significant decrease in the number of viable fetuses but no significant differences were in the fetal weight between the saline controls and the cisplatin treated sub-group. The total number of corpora lutea was similar in animals of both groups. The progesterone level per CL between control and cisplatin sub-groups were not statistically different. This suggests that the fetal loss was not directly associated with corpus luteum progesterone production.
Experiment 2:
For the mesna + cisplatin set of experiments, there was a non-significant change in the percentage of females that mated to a male. Of the females that mated with a male, there was no difference in the fecundity index for all sub-three groups. Mesna protected against the pre-implantation and postimplantation losses of the fetuses induced by cisplatin. There was a statistically significant difference in the number of resorptions seen among the control, mesna + cisplatin, and cisplatin sub-groups. Treatment with mesna leads to an increase in the total number of viable fetuses in the mesna + cisplatin compared to cisplatin. The
weight of the viable fetuses was not statistically different among the three sub-groups. After mesna and cisplatin administration, there was no difference in the total number of corpora lutea found in the saline, mesna + cisplatin and cisplatin sub-groups. The measurement of progesterone revealed that there was no difference in the progesterone level per corpus luteum in any of the three sub-groups.
Applicant's summary and conclusion
- Conclusions:
- The administration of mesna alone did not affect any of the reproductive indices in rats. Mesna protected against cisplatin induced toxicitxy: mesna administered prior to cisplatin resulted in a decrease in the rate of the pre- and post implantation loss, along with a decrease in the number of resorptions and an increase in the number of live fetuses.
- Executive summary:
The influence of Mesna on the cisplatin induced reproductive toxicity was studied in rats (Yeh at el., 2011). Cisplatin, a chemotherapeutic agent, is known to cause damage to ovaries in rats and a variety of adverse effects in foetuses of rats and mice. In humans, cisplatin caused damage to ovaries as well. Therefore, the administration of mesna prior to multiple doses of cisplatin was believed to offer protection from the loss of fertility induced by cisplatin. Adult female Sprague Dawley rats were injected with saline, cisplatin alone (4.5 mg/kg bw), mesna alone (200 mg/kg bw), mesna + saline or mesna + cisplatin, and mated with males. The female rats were divided into two groups. Group 1 served as cisplatin mating group, in which effects of cisplatin on reproductive performance of females were studied and group 2 served as the mesna + cisplatin mating group in which effects of mesna on cisplatin induced reproductive toxicity were studied. Group 1 was sub-divided into two treatment sub-groups, the saline control sub-group and the cisplatin treated sub-group. Group 2 was divided into four sub-groups, the control (saline) sub-group, the mesna + saline control subgroup, mesna + cisplatin treatment sub-group, and cisplatin only treatment sub-group. The animals were given two i.p. injections one week apart, (mesna 30 minute pretreatment with saline or cisplatin) followed by mating up to ten days after treatment. The animals were euthanized on gestational day 17 and the number corpora lutea, implantation and resorptions sites, viable and non-viable fetuses, fetal weights, and the level of progesterone per corpus luteum were determined.
In the cisplatin mating group (group 1), cisplatin caused a decrease in the percentage of females that mated to males but there was no change in the fecundity index in the animals treated with cisplatin alone and in the saline control animals. Cisplatin treated animals had an increase in the number of resorption sites and the presence of a non-viable fetus as well as an increase in the percentage of pre-implantation and post-implantation losses in comparison to the control animals. The total number of resorptions per pregnant animal was increased. There was a significant decrease in the number of viable fetuses but there were no significant differences in the fetal weight between the saline controls and the cisplatin treated sub-group. The total number of corpora lutea was similar in animals of both groups. The progesterone level per CL between control and cisplatin sub-groups were not statistically different. This suggests that the fetal loss was not directly associated with corpus luteum progesterone production.
The administration of mesna + saline did not affect any of the reproductive outcomes compared to the saline control. In the mesna + cisplatin mating group, there was a non-significant change in the percentage of females that mated to a male. Of the females that mated with a male, there was no difference in the fecundity index for all sub-three groups. Mesna protected against the pre-implantation and postimplantation losses of the fetuses induced by cisplatin. There was a statistically significant difference in the number of resorptions seen among the control, mesna + cisplatin, and cisplatin sub-groups. Treatment with mesna leads to an increase in the total number of viable fetuses in the mesna + cisplatin compared to cisplatin. The weight of the viable fetuses was not statistically different among the three sub-groups. After mesna and cisplatin administration, there was no difference in the total number of corpora lutea found in the saline, mesna + cisplatin and cisplatin sub-groups. The measurement of progesterone revealed that there was no difference in the progesterone level per corpus luteum in any of the three sub-groups.
In conclusion, prior exposure to cisplatin caused a significant adverse effects on fertility as evidenced by the decreased implantation due to increased fetal loss. The administration of mesna appeared to temper cisplatin damage by lessening the cisplatin effects on fetal resorption.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.