Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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