Dimethyl sulfoxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

The toxicity of single and repeated dermal applications of dimethyl sulfoxyde

Author:

Smith ER, Hadidian Z and Mason MM

Year:

1968

Bibliographic source:

J Clin Pharmacol, 8(5), 315-321

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Rats were immersed in a DMSO solution (40, 60, 80 or 100%) until the fur and the skin were thoroughly wetted. The animals were then withdrawn from the solution and allow most of the excess solution to run off. From the weights before and after dipping, it was possible to calculate the amount of DMSO.

GLP compliance:

no

Test type:

other:

Test material

Test material information

Constituent 1

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 article name: Dimethyl sulfoxide
Source: Schering AG (West Berlin, Germany), The Aldrich Chemical Company (Milwaukee, Wisconsin)
Purity: no data
Other: Identity analysis conducted (densities, freezing & boiling points). Density of 1.1G/mL assumed.

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:  no data
- Age at study initiation:  no data
- Weight at study initiation: 108-182 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- 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: From: To: no data

Administration / exposure

Type of coverage:

other:

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: whole body except head 
- % coverage: entire unshaven body immersed in solutions of DMSO
- Total volume applied: according to the body weight determined before and after dipping in solution : 2, 13, 33, 44 g/kg. 

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, animals were just held off after immersion to allow most of the excess solution to run off

Duration of exposure:

few seconds (time to fur and skin got thoroughly wetted)

Doses:

40, 60, 80 and 100% DMSO (according to the body weight determined before and after dipping in solution the dose levels are 2, 13, 33, 44 g/kg)

No. of animals per sex per dose:

14 (males & females) for the  undiluted solution & 4 (males & females) for each other 3 doses

Control animals:

no

Details on study design:

EXAMINATIONS:
- Duration of observation period following administration: 24H
- Frequency of observations and weighing:  clinical signs recorded and body weight measured before and after administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, microscopic examination: "complete"

Statistics:

Not reported : "LD50 estimated to be approximately"

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 40 000 mg/kg bw

Mortality:

There was no immediate response, but within 24 hours 13/14 rats dipped into 100% DMSO were dead.
No death occurred at the other concentrations.

Clinical signs:

other: No data reported. No data on local skin effects.

Gross pathology:

Intestines of the animals which did not survive were filled with yellow liquid without food, supposed to be bile and intestinal secretion.
A complete microscopic examination of tissues revealed no changes.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Under these experimental conditions, the dermal LD50 of DMSO is ca. 40000 mg/kg in Sprague Dawley rats.

Executive summary:

The acute dermal toxicity of DMSO was evaluated in male and female rats according to the immersion method.  Groups of 4 to 14 unshaven rats (108-182 g) were immersed in a DMSO solution (40, 60, 80 or 100%) until the fur and the skin were thoroughly wetted.

The animals were then withdrawn from the solution and allow most of the excess solution to run off.

According to the body weight determined before and after dipping in solution: 2, 13, 33, 44 g/kg. Animals were then observed for 24 hours.

There was no immediate response, but within 24 hours 13/14 rats dipped into 100% DMSO were dead. No death occurred at the other concentrations. Intestines of the animals that did not survive were filled with yellow liquid without food, supposed to be bile and intestinal secretion.

A complete microscopic examination of tissues revealed no changes.

Under these experimental conditions, the dermal LD50 of DMSO is ca. 40000 mg/kg in Sprague Dawley rats.