Dimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report-Date 1980-05-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

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

Test material information

Constituent 1

Reference substance name:

Dimethylamine

EC Number:

204-697-4

EC Name:

Dimethylamine

Cas Number:

124-40-3

Molecular formula:

C2H7N

IUPAC Name:

dimethylamine

Details on test material:

Dimethylamine, 40% water solution

Specific details on test material used for the study:

Dimethylamine, 40% water solution

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

20 healthy, non-preselected Caucasian volunteers (11 males and 9 females; aged 19–46 years, median age 28.3 years) without any skin or other systemic diseases were included. During the study period, the subjects were allowed to shower as usual, but they were instructed to avoid any application of detergents, emollients and moisturizers on their backs as well as natural or artificial UV exposure

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 3 minutes

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 3 minutes

Score:

0.5

Max. score:

2

Reversibility:

not reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 4

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:

Migrated information Criteria used for interpretation of results: EU

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.