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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ 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 type:
standard acute method
Limit test:
yes

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:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: ca. 50 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water/Lutrol (1:1)
- Time after start of exposure: 24 h



Duration of exposure:
14 days
Doses:
1000, 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several days on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 - < 2 000 mg/kg bw
Mortality:
see details in table in remarks on results.
Clinical signs:
Sytemic symptoms:
dyspnoea, apathy, staggering, tremor, spastic gait, ruffled fur, diarrhea, cyanosis, exsiccosis, eyelid closure, poor general state.

Local symptoms:
After 24 h: severe soft necrosis, slight edema,
After 7 days: severe parchment-like necrosis, slight edema,
After 14 days: severe parchment-like to leathery necrosis.

Body weight:
no data
Gross pathology:
Animals that died:
Heart: acute dilatation of the ventricle; acute congestion;
Stomach: bloody ulcerations;
Liver: grey-colored lobular periphery;

Any other information on results incl. tables

Mortality:

Dose mg/kg

Conc. %

Animal

1 h

24 h

48 h

7 days

14 days

2000

100

3 m

3 f

0/3

0/3

2/3

3/3

3/3

3/3

3/3

3/3

3/3

3/3

1000

100

3 m

3 f

0/3

0/3

0/3

0/3

0/3

1/3

0/3

1/3

0/3

1/3

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of 2,6-dimethylmorpholine in Sprague-Dawley rats was estimated to be > 1000 and < 2000 mg/kg bw.
The substance is classified according to Directive 67/548/EEC for acute dermal toxicity.
Executive summary:

A test group consisting of 3 animals/sex/dose was treated by single dermal application of the test substance. Twenty-four hours prior the dermal applications, the backs of the rats were shaved free of hair with electric clippers. On the testing day, the dermal applications of the test material were made in undiluted form on the exposure sites (ca.50 cm2) of the rats. After application, the exposure site was covered by wrapping the trunk of the animal with a foil which was securely taped in place. The test material remained in contact with the skin for 24 hours. After the application time the skin was washed with water/Lutrol (1:1). Observations for mortality, local reactions, and behavioral abnormalities were continued for a total of 14 days following the skin applications.

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