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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 study, comparable to guideline study with acceptable restrictions (e.g. no 48 h observation time point)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982
Reference Type:
publication
Title:
Acute toxicologic evalaution of Santocure vulcanization accelerator
Author:
Randall, D.J. and Bannister, R.M.,
Year:
1990
Bibliographic source:
Acute Toxic. Data 1 (2), 105-106

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
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 95%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
physiological saline
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
up to 72 h
Number of animals:
6 (3 males and 3 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not determined
Remarks on result:
other: score not determined at 48 h
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
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
Remarks on result:
other: score not determined at 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Other effects:
No other effects.

Any other information on results incl. tables

Slight erythema (4 x erythema grade 1.0 in 3 amimals on intact skin; 9 x erythema grad 1 in 4 animals on abraded skin) and edema (6 x edema grad 1 in 3 animals on abraded skin) were observed at 24 h after treatment. No signs of erythema or edema were visible at 72 h and the study was terminated.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a skin irritation study with 6 New Zealand White rabbits 0.5 g of CBS moistened with saline was applied under semi-occlusive dressings to clipped intact and abraded skin of each of the rabbits (three males and three females) for 24 hours. There were four application sites in each rabbit (two sites for intact, two sites for abraded skin). 24 hours post application, a Draize score of 0.33 in 6 animals was seen at the intact application sites which were reversible within 72 hours (Monsanto Co. 1982).