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Toxicological information

Skin irritation / corrosion

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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:
other: Comparable to guideline study, minor restrictions in reporting, adequate 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)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Disulfiram
EC Number:
202-607-8
EC Name:
Disulfiram
Cas Number:
97-77-8
Molecular formula:
C10H20N2S4
IUPAC Name:
disulfiram
Details on test material:
- Name of test material (as cited in study report): Tetraethylthiuram disulphide
- Physical state: White powder

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

Resultsopen allclose all
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)
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:
not irritating
Remarks:
Migrated information