Disulfiram

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Evaluation of the cutaneous-irritation potential of 56 compounds.

Author:

Guillot, J. P. et al.

Year:

1982

Bibliographic source:

Fd. Chem. Toxic. Vol. 20, pp. 563-572

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2002

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disulfiram

EC Number:

202-607-8

EC Name:

Disulfiram

Cas Number:

97-77-8

Molecular formula:

C10H20N2S4

IUPAC Name:

disulfiram

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Roucher SA, Couhé
- Weight at study initiation: 2.5 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with 0.5 ml water

Duration of treatment / exposure:

4 hours

Observation period:

at 1, 24, 48, 72 hours and at day 7 and day 14.

Number of animals:

6 animals

Details on study design:

TEST SITE
- Area of exposure: dorsal region of the trunk

SCORING SYSTEM: Draize score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

for all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

other: reassessed based on the provided PCI (OECD protocol) score of 0 (refer to attached publication)

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

for all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

other: reassessed based on the provided PCI (OECD protocol) score of 0 (refer to attached publication)

Irritant / corrosive response data:

Each treated area was scored for erythema and edema according to Draize (0-4). The scores obtained for erythema and edema at both of the treated sites in all animals were totalled, summed up for all animals and then divided by the total number of readings. The readings were performed according to OECD 404 after 1, 24, 48 and 72 h and the mean of all readings was calculated to provide a mean score termed the primary cutaneous irritation index (PCII). For further details, please refer to the attached publication. Since the PCII for the test substance was 0 according to the OECD protocol, erythema and edema scores were reassessed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was conducted similar to OECD guidelines. Under the conditions of the test, the test substance was a not skin irritating.