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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethylmorpholine
EC Number:
205-509-3
EC Name:
2,6-dimethylmorpholine
Cas Number:
141-91-3
Molecular formula:
C6H13NO
IUPAC Name:
2,6-dimethylmorpholine
Details on test material:
- Name of test material (as cited in study report): 2,6-Dimethyl-morpholin (75 % cis/25 % trans)
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
3 min and 1 h
Observation period:
8 days
Number of animals:
2 females
Details on study design:
TEST SITE
- Area of exposure: 1x1 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water/Lutrol (1:1)
- Time after start of exposure: 3 min and 1 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
, 3 min application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
, 3 min application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
, 1 h application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
, 1 h application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing

Any other information on results incl. tables

Mean edema and erythema score from the 3 min and 1 h exposure after 3 min, 1 h, 24 h, 48 h and 8 days (animal1/animal2). Data for the 72 h time point was not recorded.

   3 min     1 h     24 h     48 h     8 days   
Exposure  edema  erythema  edema  erythema  edema  erythema  edema  erythema  edema  erythema
3 min exposure  0/0 1/1  -  - 0/0 1/1 0/0 1/1 0/0 0/0
1 h exposure  -  - 2/2 3/3 2/3 4/4 2/3 4/4 1/1 4/4

The original BASF grading was converted into the numerical grading according the OECD Draize system.

The application of the test substance for 3 min caused slight, reversible erythema.

The application for 1 h caused moderate to severe edema and severe erythema. After 24 h, parchment and leather-like necrosis were observed. The observed effects are considered as full thickness necrosis. Full thickness necrosis is considered to be an irreversible effect.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is classified as corrosive to the skin according to Directive 67/548/EEC for acute dermal toxicity.
Executive summary:

Two animals were treated for 3 min or 1 h using occlusive conditions. An application site of 1x1 cm was covered with the liquid test substance. After the application time the skin was washed with water and water/Lutrol (1:1). The animals were observed for 8 days and skin changes were recorded daily.

Categories Display