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Diss Factsheets

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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Method: BASF-Test. Two animals were treated for 3 min and 4 hours using occlusive conditions. An application site of 2.5x2.5 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. 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

Constituent 1
Chemical structure
Reference substance name:
Trimethylamine
EC Number:
200-875-0
EC Name:
Trimethylamine
Cas Number:
75-50-3
Molecular formula:
C3H9N
IUPAC Name:
N,N-dimethylmethanamine
Details on test material:
- Name of test material (as cited in study report): Trimethylamin 45 % (liquid)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.83 kg (mean)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of the same animal
Duration of treatment / exposure:
3 min and 4 h
Observation period:
8 days
Number of animals:
3 min exposure: 4
4 h exposure: 2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: after the exposure (3 min and 4 h)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
mean
Time point:
24/48 h
Score:
2.9
Max. score:
4
Reversibility:
not fully reversible within: 8 days. The application caused necrosis.
Remarks on result:
other: 72 h reading is missing.
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
The application caused necrosis.
Remarks on result:
other: 72 h reading is missing.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
3 min and 4 h exposure
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
3 min and 4 hours exposure
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
4 hours exposure
Basis:
animal #1
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 hours exposure
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
4 hours exposure
Basis:
animal #2
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 hours exposure
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
48 h
Score:
2
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #2
Time point:
24/48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #3
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #4
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
4 hours exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 hours exposure
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
4 hours exposure
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 hours exposure
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #3
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #4
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

Mean erythema score after 24 and 48 h (72 h reading is missing); (animal1/2)

 Exposure time  24 h  48 h  72 h

mean

 3 min

3/3/4/2

2/3/4/2

-

2.5/3/4/2

 4 h

4/4

4/4

-

 4/4

Mean oedema score after 24 and 48 h (72 h reading is missing); (animal1/2)

 Exposure time  24 h  48 h  72 h mean
 3 min  2/2/2/2  2/1/2/2 - 2/1.5/2/2
 4 h 2/2 2/2 - 2/2

The 3 min exposure caused severe erythema and in 1 animal parchment like necrosis after 24 h. At the end of the observation period of 8 days leathery necrosis was observed. This is considered to be a full thickness necrosis.

The 4 h exposure caused soft necrosis after 24 h in both animals. At the end of the observation period of 8 days leathery necrosis was observed. This is considered to be a full thickness necrosis.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Trimethylamine is corrosive to the skin due to the irreversibility of the effects within 8 days.
Classification: Skin Corr. 1B, H314: Causes severe skin burns and eye damage
Executive summary:

A BASF AG internal procedure (1979) was used as in following described: two animals were treated for 3 min and 4 hours using occlusive conditions. An application site of 2.5x2.5 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. 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. The 3 min exposure caused severe erythema and in 1 animal parchment like necrosis after 24 h. At the end of the observation period of 8 days leathery necrosis was observed. This is considered to be a full thickness necrosis.

The 4 h exposure caused soft necrosis after 24 h in both animals. At the end of the observation period of 8 days leathery necrosis was observed. This is considered to be a full thickness necrosis. The 4 h exposure caused soft necrosis after 24 h in both animals. At the end of the observation period of 8 days leathery necrosis was observed. This is also considered to be a full thickness necrosis.