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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Development and Validation of an Alternative Dermal Sensitization Test : The Mouse Ear Swelling Test (MEST)
Author:
Gad S.C., Dunn B.J., Dobbs D.W., Reilly C., Walsh R.D.
Year:
1986
Bibliographic source:
Toxicol. Appl. Pharmacol. 84, 93-114.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Insult patch test:
50 subjects received nine 24-hour applications over a three week period and challenge patching 10 to 14 days after the final induction application.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Propan-1-ol
EC Number:
200-746-9
EC Name:
Propan-1-ol
Cas Number:
71-23-8
Molecular formula:
C3H8O
IUPAC Name:
propan-1-ol

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: 50
Route of administration:
dermal

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
RESULT OF CASE REPORT:
In all subjects the response was negative

Applicant's summary and conclusion