Registration Dossier

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 report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF-Test: Two animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethyl-aethylamin

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.95 ang 3.47 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: Skin sites of the same animal served as control
Duration of treatment / exposure:
1, 5, 15 min and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

Results and discussion

In vivo

Results
Irritation parameter:
other: necrosis
Basis:
animal: #1 and 2
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 min of exposure caused leathery to hard necrosis within 48 h. The 72 h reading is missing.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Conclusions:
Under the experimental conditions, DMEA was considered as corrosive when applied topically to rabbits.
Executive summary:

The acute dermal irritation of Dimethylethylamine (DMEA) was evaluated in Vienna White rabbits. Two animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance.

After the application time (1, 5, 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

Necrosis was observed at 24 hours that was not fully reversible in 8 days. One minute of exposure caused leathery to hard necrosis within 48 h.

Under the experimental conditions, DMEA was considered as corrosive when applied topically to rabbits.