Registration Dossier

Diss Factsheets

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:
December 23, 1987 to March 8, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/EEC, Annex V, B.4
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
EC Number:
404-310-0
EC Name:
Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
Cas Number:
10591-85-2
Molecular formula:
C30H28N2S4
IUPAC Name:
tetrakis(phenylmethyl)thioperoxydi(carbothioamide)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Albino rabbit, New Zealand White, female

Test system

Type of coverage:
semiocclusive
Vehicle:
other: 500 mg substance moistened with 0.3 ml milli-RO water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
The substance caused no adverse effects to the skin in any of the animals during the observation period. No signs of systemic intoxications were observed in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results and the calculated primary irritation index (modified) of 0, the test substance should be considered as non-irritating.
Executive summary:

Tetrabenzylthiuram disulfide (TBzTD) was tested in the rabbit primary skin irritation/corrosion test.

The flank skin of 3 albino rabbits was exposed to 0.5 gram of the test substance moistened with 0.3 ml Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin in any of the animals during the observation period.

The primary skin irritation index amounted to 0. Based on these results, the test substance should be considered as non-irritating to the skin.

According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC, the test substance need not be labelled as a skin irritant.

Categories Display