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Toxicological information

Health surveillance data

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Administrative data

health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
Lack of ocular changes with dimethyl sulfoxide therapy of scleroderma
Shirley HH, Lundergan MK, Williams HJ and Spruance SL
Bibliographic source:
Pharmacotherapy.; 9(3), 165-8

Materials and methods

Study type:
human medical data
Endpoint addressed:
other: Ophtalmology
Test guideline
no guideline followed
Principles of method if other than guideline:
Eighty-four patients, 18 years of age and older, with definite systemic sclerosis, and with skin ulcers on the hands and/or fingers of at least 3 weeks duration, were randomly assigned to one of three treatment groups: normal saline 0.85%, DMSO 2%, or DMSO 70% (the maximum  theoretical dosage of DMSO administered was 2.6 g/kg/day) they were treated for 12 weeks by immersing the more severely affected hand into a polyethylene bag of the study solution for 15 minutes 3 times daily. In addition to the clinical assessment and the usual laboratory data (urinalysis, complete blood cell count with differential, Westergren sedimentation rate, platelet count, and blood chemistry survey), an ophthalmologic examination was performed at the beginning and at the end of the 12-week study.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl sulfoxide
EC Number:
EC Name:
Dimethyl sulfoxide
Cas Number:
Molecular formula:
dimethyl sulfoxide


Type of population:
other: 84 patients, 18 y old and above, with definite systemic sclerosis 

Results and discussion

No statistical difference in these ocular variables, including visual  acuity, lenticular changes, and cataract development, were noted among  the three groups, and in no patients were the DMSO-related lenticular  changes reported in numerous animal studies found. The maximum  theoretical dosage of DMSO administered was 2.6 g/kg/day, which is  comparable to those used in the animal studies.

Applicant's summary and conclusion