Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: .

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Principles of method if other than guideline:
Skin irritation/corrosion test
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Perhydroazepine
EC Number:
203-875-9
EC Name:
Perhydroazepine
Cas Number:
111-49-9
Molecular formula:
C6H13N
IUPAC Name:
azepane
Details on test material:
- Name of test material (as cited in study report): Hexamethylenimine
- Analytical purity: 98.18 %
- Lot/batch No.: Haskell No. 8588

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1.5 x 1.5 inch

SCORING SYSTEM:
-Evaluation of skin reactions: immediately after removal of the patch and 24 and 48 h after initial application.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: Corrosion was observed within the observation period of 48h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
All six animals showed skin corrosion. (no further information given regarding time points, individual scores, reversibiliy).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the test substance induced skin corrosion in all six animals.
Executive summary:

A skin irritation/corrosion test was performed with six rabbits. The animals were exposed to 0.5 ml of test substance on the clipped skin under occlusive conditions for 4 h. The skin reactions were observed for 48 h after the initial exposure. All six animals showed skin corrosion.