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Toxicological information

Skin irritation / corrosion

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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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Method: other: BASF-Test: Four animals were treated for 3 min and two animals were treated for 1 hour using occlusive conditions. An application site of 2 X 2 cm was covered with the liquid test substance. After the application the skin was washed with Lutrol (50 %). The animals were observed for 8 days and skin changes were recorded daily.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimethylamin, 40%-ige waessrige Loesung

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
3 min and 4 houres
Observation period:
8 days
Number of animals:
3 min exposure: 4
4 hours exposure: 2
Details on study design:
TEST SITE
- Area of exposure: 2 X2 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 3 nin and 4 h


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 minutes
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 minutes
Score:
0.5
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Classification: corrosive (causes burns)
Executive summary:

BASF AG performed a test for acute toxicity by dermal application in 1980. Dimethylamine was applied once for 24 hours to the clipped skin of the back and flank (area about 48 cm²) unchanged in a dose of 5000, 4000, 3200, 2500 or 400 mg/kg bw. The coverage of the treated area was creating occlusive conditions. The treated area of skin was then covered with an inert foil, which was secured in position with adhesive tape. The bandage was removed after an exposure period of 24 hours; subsequently, the test substance was washed off with warm water or a mixture of water/Lutrol and dried with cellulose. Mortality was observed as well as abnormalities in gross pathology. Clinical signs were systemic (apathy, convulsions, crying). With the highest dosage 6 animals died after 24 hours, as well as with a dosage of 4000 mg/kg bw; whereby another animal died after 48 hours. By application of dimethylamine in a concentration of 3200 mg/kg bw one animal died after 1 hour and two more animals after 24 hours. Just one animal died after 24 hours by the usage of 2500 mg/kg bw and no mortality occurred by a dosage of 400 mg/kg bw. Pathology performed revealed: acute dilatation of the heart, congestive hyperemia, peripheral lobule marking in the liver, and edema in the lung.