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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
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
Type of study:
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

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
75 % in petrolatum
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
75 % in petrolatum
No. of animals per dose:
49 volunteers

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Irritation during induction phase
Group:
test group
Dose level:
75 %
No. with + reactions:
31
Total no. in group:
49
Remarks on result:
other: Reading:
Reading:
other: sensitizing during induction phase
Group:
test group
Dose level:
75 %
No. with + reactions:
24
Total no. in group:
49
Remarks on result:
other: Reading:

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:
sensitising
Remarks:
Migrated information
Executive summary:

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