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EC number: 200-664-3 | CAS number: 67-68-5
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The toxicity of dimethyl sulphoxide (DMSO) for the dog, pig, rat and rabbit
- Author:
- Noel PRB, Barnett KC, Davies RE, Jolly DW, Leahy JS, Mawdesley-Thomas LE, Shillam KWG, Squires PF, Street AE, Tucker WC and Worden AN
- Year:
- 1 975
- Bibliographic source:
- Toxicology, 3 (2), 143-69
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- yes
- Remarks:
- no blood chemistry and histopathology
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyl sulfoxide
- EC Number:
- 200-664-3
- EC Name:
- Dimethyl sulfoxide
- Cas Number:
- 67-68-5
- Molecular formula:
- C2H6OS
- IUPAC Name:
- dimethyl sulfoxide
- Details on test material:
- Test compound: dimethylsulfoxide
Source: Crown Zellerbach Corporation
Batch number: no data
Purity: Pharmaceutical-grade
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: Charles River Breeding Laboratories, Wilmington, Massachusetts, USA
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 5 to a cage;
- Diet (e.g. ad libitum): Spillers autoclaved Laboratory Small Animals diet
- Water: ad libitum)
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: 1965-1967
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 2 to 18 mlKg bw/d according to the dose levels - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 months (78 weeks)
- Frequency of treatment:
- 5 days/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 3 and 9 ml/kg bw/d (1100 - 3300 - 9900 mg/kg bw/d)
Basis:
- No. of animals per sex per dose:
- 50 males and 50 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
Groups of 50 male and 50 female Sprague Dawley rats received oral daily doses, 5 days a week for a total of 18 months (78 weeks), of 1, 3 or 9 ml/kg DMSO (50% aqueous solution), a control group received 9 ml distilled water/kg/day.
After 52 weeks, 10 males and 10 females from each were sacrificed. Animals were observed daily, weighed weekly and food intake was calculated at weekly intervals. Ophthalmoscopic examination of the eyes of all animals was made before dosing and then at regular intervals throughout the study. Hematology studies (PCV, haemoglobin, total and differential white cell count and prothrombin index), together with urinalysis and measurement of urine concentration were performed on sample animals from each group after 4, 12, 20, 32, 51, 60 and 72 weeks.
After 78 weeks remaining animals were sacrificed and their tissues preserved. - Positive control:
- Not appropriate
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION : No data
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before dosing and then at regular intervals
- Group examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 4, 12, 20, 32, 51, 60 and 72 weeks
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
URINALYSIS: Yes
- Time schedule for collection of urine: 4, 12, 20, 32, 51, 60 and 72 weeks
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No - Statistics:
- Numerical results were subjected to statistical analysis, comprising analysis of variance followed by Student's 't' test. The result of the analysis was usually expressed as the least difference that had to exist between test and control group means before a 5% or 1% level of significance was reached
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- but not relevant
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- but not relevant
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- >= 1 ml/kg/day (slight decrease < 10%)
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- at 9 ml/kg/day
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- at 9 ml/kg/day
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Mortalities were few and could not be related to DMSO treatment. Occasional behavioural changes, persisting for about 5 min after dosing, were observed. These consisted of stretching and arching of the back, accompanied by an in-drawing of flanks and abdomen, and were attributed to abdominal discomfort.
BODY WEIGHT AND WEIGHT GAIN-FOOD CONSUMPTION
Bodyweight records indicated a dose-related depression of weight gain in both sexes (<10%), with the exception of males receiving 1 ml/kg (Figures 7 and 8). There was no accompanying reduction of food intake.
OPHTHALMOSCOPIC EXAMINATION
Examination of the eye revealed no changes in the retina or vitreous. No peripheral (equatorial) opacities were seen and there was no difference in incidence of polar opacities between test and control animals. Prominent nuclear annuli were seen in a small number of animals towards the end of the study, as expected, but there was no dose-relationship to suggest any increase resulting from administration of DMSO. The only relevant finding was some degree of change in the refractive index of the nuclear region in 3 rats receiving 9 ml/kg.
HAEMATOLOGY
Laboratory investigations were limited to haematological tests, the only abnormality being a slight reduction of haemoglobin and PCV in male rats receiving 9 ml/kg.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 3 300 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Slight decreased (<10%) of mean body weight gain at all dose levels and sexes except males at 1100 mg/kg bw/d.
- Dose descriptor:
- LOAEL
- Effect level:
- 9 900 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Slight decreased Hb and PCV in male at 9900 mg/kg bw/d. Changes in the lens of the eye at 9900 mg/kg bw /d
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The potential toxicity of DMSO was evaluated following repeated oral administration for 78 weeks. Groups of 50 male and 50 female Sprague Dawley rats received oral daily doses, 5 days a week for a total of 18 months (78 weeks), of 1, 3 or 9 ml/kg DMSO (50% aqueous solution), a control group received 9 ml distilled water/kg/day.
After 52 weeks, 10 males and 10 females from each were sacrificed. Animals were observed daily, weighed weekly and food intake was calculated at weekly intervals. Ophthalmoscopic examination of the eyes of all animals was made before dosing and then at regular intervals throughout the study. Haematology studies (PCV, haemoglobin, total and differential white cell count and prothrombin index), together with urinalysis and measurement of urine concentration were performed on sample animals from each group after 4, 12, 20, 32, 51, 60 and 72 weeks.
After 78 weeks remaining animals were sacrificed and their tissues preserved.
Mortalities were few and could not be related to DMSO treatment. Occasional behavioural changes, persisting for about 5 min after dosing, were observed. These consisted of stretching and arching of the back, accompanied by an in-drawing of flanks and abdomen, and were attributed to abdominal discomfort.
Bodyweight records indicated a dose-related depression of weight gain in both sexes, with the exception of males receiving 1 ml/kg (Figures 7 and 8). There was no accompanying reduction of food intake.
Examination of the eye revealed no changes in the retina or vitreous. No peripheral (equatorial) opacities were seen and there was no difference in incidence of polar opacities between test and control animals. Prominent nuclear annuli were seen in a small number of animals towards the end of the study, as expected, but there was no dose-relationship to suggest any increase resulting from administration of DMSO. The only relevant finding was some degree of change in the refractive index of the nuclear region in 3 rats receiving 9 ml/kg.
Laboratory investigations were limited to haematological tests, the only abnormality being a slight reduction of haemoglobin and PCV in male rats receiving 9 ml/kg.
Under the experimental conditions, the No Observed Adverse Effect Level (NOAEL) is 3300 mg/kg/day and the LOAEL is 9900 mg/kg/day for the ophthalmology and haematology effects. - Executive summary:
The potential toxicity of DMSO was evaluated following repeated oral administration for 78 weeks. Groups of 50 male and 50 female Sprague Dawley rats received oral daily doses, 5 days a week for a total of 18 months (78 weeks), of 1, 3 or 9 ml/kg DMSO (50% aqueous solution); a control group received 9 ml distilled water/kg/day.
After 52 weeks, 10 males and 10 females from each group were sacrificed. Animals were observed daily, weighed weekly and food intake was calculated at weekly intervals. Ophthalmoscopic examination of the eyes of all animals was made before dosing and then at regular intervals throughout the study. Haematology studies (PCV, haemoglobin, total and differential white cell count and prothrombin index), together with urinalysis and measurement of urine concentration were performed on sample animals from each group after 4, 12, 20, 32, 51, 60 and 72 weeks. After 78 weeks remaining animals were sacrificed and their tissues preserved.
Mortalities were few and could not be related to DMSO treatment. Occasional behavioural changes, persisting for about 5 min after dosing, were observed. These consisted of stretching and arching of the back, accompanied by an in-drawing of flanks and abdomen, and were attributed to abdominal discomfort. Bodyweight records indicated a slight dose-related depression of weight gain (<10%) in both sexes, with the exception of males receiving 1 ml/kg. There was no accompanying reduction of food intake. Examination of the eye revealed no changes in the retina or vitreous. No peripheral (equatorial) opacities were seen and there was no difference in incidence of polar opacities between test and control animals. Prominent nuclear annuli were seen in a small number of animals towards the end of the study, as expected, but there was no dose-relationship to suggest any increase resulting from administration of DMSO. The only relevant finding was some degree of change in the refractive index of the nuclear region in 3 rats receiving 9 ml/kg. Laboratory investigations were limited to haematological tests, the only abnormality being a slight reduction of haemoglobin and PCV in male rats receiving 9 ml/kg.
The No Observed Adverse Effect Level (NOAEL) is 3300 mg/kg/day based on the slight depression of the body-weight gain and the LOAEL is 9900 mg/kg/day for the ophthalmology and haematology effects.
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