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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute 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:
A toxicologic study of dimethyl sulfoxide
Author:
Willson JE, Brown DE and Timmens EK
Year:
1965
Bibliographic source:
Toxicol. Appl. Pharmacol. 7: 104-112

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test compound: Dimethylsulfoxyde
Source: Crown Zellerbach Corp.
Batch : no data
Purity : no data

Test animals

Species:
rat
Strain:
other: Carworth CFN
Sex:
male/female
Details on test animals and environmental conditions:
Initial body weight: 112-130 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Animals were fasted for 16-18 hr prior to DMSO administration.
Doses:
10, 20, and 40 g/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Median lethal dose (LD50), 95% confidence limit, and probit slopes were determined by the Cornfield-Mantel modifications of Karber's method

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
28 300 mg/kg bw
Remarks on result:
other: Lethal doses caused ataxia, myasthenia, decreased motor activity, and bradypnea
Mortality:
With one exception, all deaths occurred within the first 24 hours.
Clinical signs:
Lethal doses caused ataxia, myasthenia, decreased motor activity, and bradypnea shortly after administration.
Non-lethal doses of DMSO produced decreased motor activity, although polydipsia and polyuria were noted in rats following doses of 20 g/kg.
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under these experimental conditions, a LD50 of 28500 mg/kg has been calculated in rats.
Executive summary:
The Acute oral toxicity of Dimethylsulfoxide (DMSO) was evaluated in rats according to a protocol similar to the OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 males and 5 females Carworth CFN rats were given a single oral dose of DMSO at doses of 10000, 20000 and 40000 mg/kg. Following treatment, rats were observed during 14 days.

With one exception, all deaths occurred within the first 24 hours.

Lethal doses caused ataxia, myasthenia, decreased motor activity, and bradypnea shortly after administration.

Non-lethal doses of DMSO produced decreased motor activity, although polydipsia and polyuria were noted in rats following doses of 20 g/kg.

Under these experimental conditions, the oral LD50 of DMSO is 28500 mg/kg in Carworth CFN rats.