Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: unusual test method; high compound oncentration used; insufficient 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

Principles of method if other than guideline:
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
GLP compliance:
no
Type of study:
patch test

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:
IUCLID4 Test substance: other TS: CHA undiluted

In vivo test system

Test animals

Species:
other: laboratory animal
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: dermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
i100 % (undiluted test material)
Challengeopen allclose all
Route:
other: dermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
i100 % (undiluted test material)
No. of animals per dose:
no data
Details on study design:
patch test:
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
Challenge controls:
no data
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
no data

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Results
Reading:
other: readong
Group:
test chemical
Dose level:
100 %
Clinical observations:
dull-red discoloration with edema, slight maceration, and possibly petechiae.
Remarks on result:
other: Reading: other: readong. Group: test group. Dose level: 100 %. Clinical observations: dull-red discoloration with edema, slight maceration, and possibly petechiae. .

Any other information on results incl. tables

RS-Freetext:
CHA was evaluated as moderately sensitizing.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information