Dimethyl sulfoxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

Usefulness and limitations of various guinea-pig test methods in detecting human skin sensitizers-validation of guinea-pig tests for skin hypersensitivity

Author:

Marzulli F and Maguire HC

Year:

1982

Bibliographic source:

Food Chem. Toxicol., 20, 67-74

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study conducted before the LLNA was implemented.

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 : DMSO
Source: Crown Zellerbach Corporation, Camas, Washington
Batch number: no data
Purity: no data

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 350 g
- Housing: metal cages on wood shavings
- Diet (e.g. ad libitum): fresh Purina guinea pig Chow
- Water (e.g. ad libitum): ad libitum tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3+/-1.4 °C (65+/-5 °F)
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To: no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: ethanol

Induction 2

Concentration / amount:

1st application: Induction 50 % active substance intracutaneous
2nd application: Induction 50 % active substance occlusive epicutaneous
3rd application: Challenge 100 % active substance occlusive epicutaneous

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: ethanol

Challenge 2

Concentration / amount:

1st application: Induction 50 % active substance intracutaneous
2nd application: Induction 50 % active substance occlusive epicutaneous
3rd application: Challenge 100 % active substance occlusive epicutaneous

No. of animals per dose:

The test was repeated 3 times with groups of 10 guinea pigs.

Details on study design:

Ten guinea-pigs were clipped in the mid dorsal region near the scapula.
Three sets of two intradermal injections (0.1 ml each) were given to each animal as follows:
(1) CFA emulsified with an equal volume of sterile distilled water;
(2) a 5% (liquids v/v) concentration of DMSO in saline,
(3) a 10% (liquids v/v; solids w/v) concentration of DMSO in saline emulsified with an equal volume of CFA.

On day 6 the injected sites were inspected and if there was no significant irritation at that time, 5% sodium lauryl sulphate was applied. If there was significant irritation, no SLS was applied to the site.
On day 7, the area of the injections was clipped and 0.5 ml of the test compound was applied to a 1-in square of Whatman No. 2 filter paper. The paper was positioned face down on the induction site and sealed in place with Blenderm, Elastoplast and adhesive tape as in the Buehler wrappings.

A challenge was made on day 21 with 0.5 ml of test material at a high non-irritant concentration. Application was made to a clipped site on the left flank using Whatman No. 2 filter paper and a sealing of Blenderm, Elastoplast and Scanpore adhesive tape. The dressing was removed 24 hr later and readings were made 1 and 2 days later (i.e. 48 and 72 hr after the challenge).

Positive control substance(s):

yes

Remarks:

Captan together with 8 possible allergenic substances that have been used in the cosmetic industry

Results and discussion

Positive control results:

Positive controls: 7 out the 9 substances tested induced a positive response.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 ml of 100% DMSO

No. with + reactions:

0

Total no. in group:

30

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml of 100% DMSO. No with. + reactions: 0.0. Total no. in groups: 30.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.5 ml of 1% solution

No. with + reactions:

24

Total no. in group:

30

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 ml of 1% solution. No with. + reactions: 24.0. Total no. in groups: 30.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

not sensitizing

Executive summary:

The delayed contact hypersensivity of Dimethylsulfoxide (DMSO) was evaluated in Guinea pigs according to the Magnusson and Kligman test.

The induction phase has been realized both by intradermal route on day 1 (DMSO 50 % in ethanol) and by cutaneous route on day 8 (DMSO 50 % in ethanol) in 10 females guinea pigs. The challenge phase was realized on day 21 by cutaneous application of DMSO 100 %. The dressing was removed 24 hr later and readings were made 1 and 2 days later (i.e. 48 and 72 hr after the challenge).

This test was repeated thrice.

No positive reaction has been observed.

In conclusion, under these experimental conditions, DSMO was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.