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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable well-documented study report which meets basic scientific principles
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
other: Repeated Insult Patch Test modified Shelanski (4 x 4 Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
N-oxydiethylene-benzothiazole sulphenamide, brown granules

Test animals

Species:
human

Test system

Type of coverage:
occlusive
Preparation of test site:
other: no preparation
Vehicle:
other: petrolatum
Controls:
not required
Duration of treatment / exposure:
four consecutive 24 h periods each week, for three consecutive weeks (induction phase)
Observation period:
see text field material and methods
Number of animals:
49 volunteers

Results and discussion

In vivo

Results
Irritation parameter:
other: primary skin irritation
Basis:
other: 49 volunteers
Time point:
other: immediate after exposure
Score:
31
Max. score:
49
Reversibility:
no data
Remarks on result:
other: 31/49 volunteers with positive skin irritation reactions

Any other information on results incl. tables

Irritation:

The test material elicited irritation in 31/49 individuals.This was well over 50 % of the panelists participating in the study. Minimal or moderate erythema was the extent of irritation in seven (7/49) of these individuals, the picture in the remaining 24 individuals was quite different.

Sensitizing:

During induction phase: 24 individuals (24/49) showed intensive or very intense irritation, consisting of erythema, induration, weeping, and extension beyond the margin of the contact site. The characteristics of these responses were consistent with that of a sensitizing effect.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

The test material elicited irritation in 31/49 individuals (Monsanto Co. 1982).