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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and comparable to guideline study with acceptable restrictions (e.g. no observation time point at 48 h post-treatment)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Reference Type:
publication
Title:
Acute toxicologic evaluation of Santocure NS vulcanization accelerator
Author:
Randall, D.J. and Bannister, R.M.,
Year:
1990
Bibliographic source:
Acute Toxic. Data 1 (2), 104-105

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 48 h observation time point, 24 h exposure time, intact and abraded skin tested
Principles of method if other than guideline:
The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits. The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
producte code: S-NS-B-45, purity: 97%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 (3 males, 3 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
not determined
Remarks on result:
other:
Remarks:
score not determined at 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
not determined
Remarks on result:
other:
Remarks:
score not determined at 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites

Any other information on results incl. tables

Slight erythema and edema were observed at 24 hours after treatment at the abraded sites. No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment. No signs of erythema or edema were visibile at 72 hours at the abraded sites and the study was terminated.

Total Draize score: 0.1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment.
Executive summary:

The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits (Monsanto Co. 1982). The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours.

Slight erythema and edema were observed at 24 hours after treatment at the abraded sites. No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment. No signs of erythema or edema were visibile at 72 hours at the abraded sites and the study was terminated.