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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 4 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 report describes findings after 24 hours and at the end of the observation period (8 days).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethylamine
EC Number:
204-697-4
EC Name:
Dimethylamine
Cas Number:
124-40-3
Molecular formula:
C2H7N
IUPAC Name:
N-methylmethanamine
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 h
Observation period:
8 days
Number of animals:
3 min exposure: 2
4 h exposure: 4
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 3 min and 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Exposure time: 3 min
Basis:
animal #1
Remarks:
Animal No. 1 of a total of 2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 2 animals
Irritation parameter:
erythema score
Remarks:
Exposure time: 3 min
Basis:
animal #2
Remarks:
Animal No. 2 of a total of 2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 2 animals
Irritation parameter:
edema score
Remarks:
Exposure time: 3 min
Basis:
animal #1
Remarks:
Animal No. 1 or a total of 2
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
positive indication of irritation
Remarks:
The score given above is the mean value reported for the 2 animals
Irritation parameter:
edema score
Remarks:
Exposure time 3 min
Basis:
animal #2
Remarks:
Animal No. 2 of a total of 2
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 2 animals
Irritation parameter:
erythema score
Remarks:
Exposure time 4h
Basis:
animal #1
Remarks:
Animal No. 1 of a total of 4
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
erythema score
Remarks:
Exposure time 4 h
Basis:
animal #2
Remarks:
Animal No. 2 of a total of 4 animals
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
erythema score
Remarks:
Exposure time 4 h
Basis:
animal #3
Remarks:
Animal No. 3 of a total of 4
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
erythema score
Remarks:
Exposure time 4 h
Basis:
animal #4
Remarks:
Animal No. 4 of a total of 4
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
edema score
Remarks:
Exposure time 4 h
Basis:
animal #1
Remarks:
Animal No. 1 of a total of 4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
edema score
Remarks:
Exposure time 4 h
Basis:
animal #2
Remarks:
Animal No. 2 of a total of 4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
edema score
Remarks:
Exposure time 4 h
Basis:
animal #3
Remarks:
Animal No. 3 of a total of 4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
edema score
Remarks:
Exposure time 4 h
Basis:
animal #4
Remarks:
ANimal No. 4 of a total of 4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Observation period 8 days
Remarks on result:
probability of severe irritation
Remarks:
The score given above is the mean value reported for the 4 animals
Irritation parameter:
erythema score
Remarks:
Exposure time 3 min and Exposure time 4 h
Basis:
animal #1
Time point:
48 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
erythema score
Remarks:
Exposure time 3 min and Exposure time 4 h
Basis:
animal #2
Time point:
48 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
erythema score
Remarks:
Exposure time 3 min and Exposure time 4 h
Basis:
animal #1
Time point:
72 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
edema score
Remarks:
Exposure time 3 min and Exposure time 4 h
Basis:
animal #2
Time point:
72 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
erythema score
Remarks:
Exposure time 4 h
Basis:
animal #3
Time point:
48 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
erythema score
Remarks:
Exposure time 4 h
Basis:
animal #4
Time point:
48 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
edema score
Remarks:
Exposure time 4 h
Basis:
animal #3
Time point:
72 h
Reversibility:
other: As no value has been reported:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
edema score
Remarks:
Exposure time 4 h
Basis:
animal #4
Time point:
72 h
Reversibility:
other: As no value has been repoted:
Remarks:
not applicable
Remarks on result:
other: The time points reported were 24 hours and 8 days
Remarks:
not stated
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Classification: corrosive (causes burns)
Executive summary:

A BASF AG internal procedure for skin irritation was used as in following described: two animals were treated with a 40 % DMA solution for 3 min and 4 animals for 4 hours 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. On days 1 to 8 the exposure sites were examined and scored for erythema and edema on a graded scale of 0 to 2 or 4 respectively. The test substance was corrosive to the skin of rabbits. The report describes findings after 24 hours and at the end of the observation period (8 days). The 3 min exposure caused in every animal severe erythema and slight edema. The 4 h exposure caused severe erythema and severe edema.