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EC number: 200-665-9 | CAS number: 67-71-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of methylsulfonylmethane in rats
- Author:
- K. Horvath
- Year:
- 2 002
- Bibliographic source:
- Food and Chemical Toxicology
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The objective of this study was to evaluate the subchronic toxicity of test substance in rats.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl sulphone
- EC Number:
- 200-665-9
- EC Name:
- Dimethyl sulphone
- Cas Number:
- 67-71-0
- Molecular formula:
- C2H6O2S
- IUPAC Name:
- dimethyl sulphone
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Cardinal Nutrition, Inc.(OptiMSMTM Vancouver, WA, USA)
- Lot/batch No.of test material: #99121.11
- Expiration date of the lot/batch: no data
- Purity test date: no data
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: no data
- Specific activity: no data
- Locations of the label: no data
- Expiration date of radiochemical substance: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:no data
- Preliminary purification step (if any): no data
- Final dilution of a dissolved solid, stock liquid or gel: no data
- Final preparation of a solid: no data
FORM AS APPLIED IN THE TEST (if different from that of starting material): no data
OTHER SPECIFICS: no data
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Hungary Ltd (Budapest, Hungary)
- Age at study initiation: 5 weeks old
- Weight at study initiation: 84-108 g
- Fasting period before study: Overnight
- Housing: Rats were housed two per cage of the same sex in Type II macrolon cages.
- Diet (e.g. ad libitum): standardized rat and mouse diet VRF-1 (Altromin GmbH, Lage, Germany)
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±30 °C
- Humidity (%): between 30 and 80%
- Air changes (per hr): 15 times per h
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycles
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: 1500 mg/kg of MSM in a volume of 10 ml/kg distilled water.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Concentration in vehicle: 1.5 g/kg (1500 mg/kg)
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): A0010699
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Dose / conc.:
- 1 500 other: mg/kg
- No. of animals per sex per dose:
- Total: 80 rats
40 males and 40 females - Control animals:
- yes
- Details on study design:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes (measured weekly)
Mean food consumption was calculated from the amount consumed in 10 cages (20 animals)
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: 5 male & 5 female rats
- Parameters that were examined:
Erythrocyte (RBC), leukocyte (WBC) and platelet (PLT) counts, hematocrit (Hct) and mean corpuscular hemoglobin (MCH) using a Coulter AcT8 cytometer (Coulter Diagnostics, FL, USA).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters that were examined: serum enzymes, lipid profile,serum proteins, albumin and blood chemistries
URINALYSIS: Yes
- Time schedule for collection of urine: prior to treatment and on week 7
- Metabolism cages used for collection of urine: No data
- How many animals: 5 male & 5 female rats
- Animals fasted: No data
- Parameters that were examined: Appearance,volume, specific gravity, pH, protein, glucose and blood
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: No data
OTHER
DETAILED MORTALITY OBSERVATIONS: Yes
- Time schedule: Twice daily - Sacrifice and pathology:
- Necropsy was performed 91 days after initiation of treatment.
GROSS PATHOLOGY: Yes
A full gross necropsy was performed. The following organs were weighed, examined: liver, kidneys, adrenals, left testicle, spleen, brain, thymus, heart, mesenteric lymph nodes, submandibular lymph nodes, stomach, duodenum, pancreas, lungs, pituitary, trachea, esophagus, thyroids, parthyroids, left epididymis, prostate, uterus and ovaries, right testes and epididymis, bone marrow.
HISTOPATHOLOGY: Yes - Statistics:
- Bartlett’s test of variances was used to compare variances among treatment groups. If the variances proved to be homogeneous, one-way analysis of variance (ANOVA) was performed. If ANOVA detected significant differences (P <0.05), a Dunnett’s test for comparing treatment means with a control was used.
If the values for the treatment groups failed Bartlett’s homogeneity test, the Kruskal–Wallis non-parametric ANOVA was performed. If significant differences were found among the groups, distribution-free multiple comparisons were performed.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical sings was observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No hematological alterations were measured. All hematology data were within normal limits.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No blood chemistry alterations were measured. All blood chemistry values were within normal physiologic ranges.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Urinalysis was normal without glucosuria, proteinuria or hematuria.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No difference in organ weights between the two groups were observed in comparison to the control group.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological lesions were noted.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment-related lesions were seen in the kidneys of rats receiving the limit dose of 1500 mg/kg MSM by the oral route. There were no other treatment related histopathologic findings in any of the kidneys of the control or test substance treated males and females.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Oral administration of 1500 mg/kg/day (1.5 g/kg/day) MSM for 90 days did not cause any adverse effects or mortality. Body weight and estimated food consumption were not affected. No hematological or clinical chemical alterations were noted. No gross pathological lesions were noted. Renal histology of treated animals was normal.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- urinalysis
- other: No any adverse effects was observed
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Oral administration of 1500 mg/kg/day (1.5 g/kg/day) test substance for 90 days did not cause any adverse effects or mortality. Body weight and estimated food consumption were not affected. No hematological or clinical chemical alterations were noted. Renal histology of treated animals was normal.Thus, the no-observed adverse effect level (NOAEL) of test substance in this 90 day gavage study was determined to be 1500 mg/kg/day.
- Executive summary:
In a subchronic study, male and female Wistar [Crl:(WI)BR] rats (20/sex) were orally administered (via gavage) either distilled water or 1500 mg/kg/day of test substance in distilled water for 90 days. The major organs were weighed and fixed in formaldehyde for histopathological observations, and clinical chemistry parameters (i.e., serum enzymes, lipid profile,serum proteins, albumin and blood chemistries) and urinalysis parameters (i.e., appearance, volume, specific gravity, pH, protein, glucose, and blood) were analyzed. No effects on body weight, hematological parameters or histopathological lesions in organs and tissues were found. At necropsy, no gross pathological changes or differences in organ weights were noted, except for a significant increase in kidney weights of treated male rats. Histopathological examination of kidneys in both males and females did not reveal any treatment related lesions, and therefore the significant kidney weight difference was considered likely due to low within-group deviations rather than a toxicological effect. Thus, the no-observed adverse effect level (NOAEL) of test substance in this 90 day gavage study was determined to be 1500 mg/kg/day.
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