2,6-dimethylmorpholine

Endpoint summary

Description of key information

Irritation:
- skin: corrosive
- eye: corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Internal test method, see details in "Any other information on materials and methods incl. tables"

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

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

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

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 grading according to the internal test method 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.

 

 

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Additional information

Skin irritation:

In a primary skin irritation study with undiluted test substance two animals were treated for 3 min or 1 h using occlusive conditions (BASF AG, 1981; Val. 2). 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. 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.

Only mild irritating effects to skin were found in a further study with the test substance where only limited data is provided (Smyth et al. 1962; Val. 2).

 

Eye irritation:

Highly irritating to corrosive effects to eyes were found in a study with with the test substance where only limited data is provided (Smyth et al. 1962; Val. 2).

In general, as the test substance is corrosive the skin, it can be expected to have a similar effect on the eyes also.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. In a reliable rabbit study the test substance was found to be corrosive to skin. As a result, the substance is classified for skin corrosion Cat. 1B (H314) and severe eye damage Cat. 1 (H318) under Regulation (EC) No. 1272/2008, as amended for the seventeenth time in Regulation (EC) No. 2021/849.