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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: this study cannot be used for evaluation purposes due to the high concentration involved and the lack of relevant documentation

Data source

Reference
Reference Type:
publication
Title:
Studies on the toxicity and skin effects of compounds used in the rubber and plastics industries
Author:
Mallette, F. S.; von Haam, E.
Year:
1952
Bibliographic source:
A.M.A. Arch. Ind. Hyg. Occup. Med. 5, 311 - 317

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Not less than 15 individuals; TS was placed by patch on the skin of the back and remained for 48 hours. A diluted product was applied. The sensitizing effect was determined by reapplying the material to the skin after a waiting period of 14 days
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexylamine
EC Number:
203-629-0
EC Name:
Cyclohexylamine
Cas Number:
108-91-8
Molecular formula:
C6H13N
IUPAC Name:
cyclohexanamine
Details on test material:
diluted (25 %); no further data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: not less than 15
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
Not less than 15 individuals; TS was placed by patch on the skin of the back and remained for 48 hours. A diluted product was applied. The sensitizing effect was determined by reapplying the material to the skin after a waiting period of 14 days.
The reactions are read as negative, light, moderate, or severe.
Light reaction consists of a faint pinkish discoloration of the skin with slight scaling at late observation
Moderate reaction consistsof a dull red discoloration with edema, slight maceration, and possibly petechiae.
a severe reacttion consists of a painful , hemorrhagic inflammatory reaction followed by central necrosis and ulceration

Results and discussion

Results of examinations:
RM-Freetext: A slightly sensitizing effect was determined.
Reactions: faint pinkish discoloration of the skin with slight scaling

Applicant's summary and conclusion