Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
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

Data source

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

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
other: Repeated Insult Patch Test modified Shelanski (4 x 4 Method)

Test material

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

Method

Type of population:
general
Route of administration:
dermal

Results and discussion

Results of examinations:
irritation: 31/49 individuals
sensitizing: 24/49 individuals

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

Executive summary:

The test substance (75 % preparation in pet.) induced a allergic response in 24/49 human volunteeres (Monsanto Co.1982).