Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 40 CFR, Part 163, Section 163.81-5, Federal Register, August 22, 1978.
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Exposure duration of 24 hours
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
5,5'-dithiodi-1,3,4-thiodiazole-2(3H)-thione
IUPAC Name:
5,5'-dithiodi-1,3,4-thiodiazole-2(3H)-thione
Constituent 2
Chemical structure
Reference substance name:
5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione
EC Number:
276-763-0
EC Name:
5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione
Cas Number:
72676-55-2
Molecular formula:
C4-H2-N4-S6
IUPAC Name:
5-[(5-sulfanylidene-4,5-dihydro-1,3,4-thiadiazol-2-yl)disulfanyl]-2,3-dihydro-1,3,4-thiadiazole-2-thione
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals were housed and maintained according to the Animal Welfare Act (Pub. L-94-279) 9 C.F.R. Part 3.

Animal husbandry conditions:
Temperature - 70ºF ±5ºF
Relative humidity - 45% ± 5%
Light - 12 hour light/dark cycle
Diet - Wayne 15% rabbit ration and tap water provided ad libitum.
Caging - Stainless steel with elevated wire mesh flooring 1 rabbit per cage.
Weight - weighing between 2.0 and 3.0 kg.
Age - approximately 9-10 weeks of age.
Acclimatisation - for at least 5 days prior to study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: abraded or intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A 0.5 gram sample of 5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione was dosed as supplied and applied to two abraded and two intact skin sites on the same animal.
Duration of treatment / exposure:
Exposure of the material over a period of 24 hours, at the end of which the sites were wiped but not washed and the treated areas examined.
Observation period:
Readings were taken after 24 hours and again made after 72 hours.
The Draize method of scoring was employed. All lesions observed were recorded.
Number of animals:
six

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The Primary Irritation score was 0 and the average combined irritation score was 0 for Erythema and Eschar formation and Edema formation in all animals over 72 hours on both abraded and intact skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not skin irritating
Conclusions:
5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione is not classified as a primary skin irritant to the skin of albino rabbits.