Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
other: modified Draize skin sensitization study
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santoflex IP

Method

Type of population:
general
Route of administration:
dermal

Results and discussion

Results of examinations:
12/82 volunteers with positive skin reactions

Any other information on results incl. tables

Twelve subjects of 82 patched with Santoflex IP were deemed sensitized

Applicant's summary and conclusion