Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin: BASF AG, 1979. Industrial hygiene orientating investigation, Report Nr.77/361, rabbits, 24 h occlusive, undiluted.

Skin: BASF AG, 1960, report Nr. VI/389, 24 / 48 / 72 h occlusive.
Eye: BASF AG, 1979. Industrial hygiene orientating investigation, Report Nr. 77/361, Draize Test, rabbits, 100 µL single application.
Respiratory irritation: Gagnaire et al., 1989. Nasal Irritation and Pulmonary Toxicity of Aliphatic Amines in Mice. Mice, range of exposure 17-70 ppm

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Reason / purpose for cross-reference:
reference to same study
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
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)
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)

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

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
Draize Test
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.97 kg
- Diet: SSNIFF, ad libitum
- Water: tap water, ad libitum

Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as saline-control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL
Duration of treatment / exposure:
single application, eyes were not washd out
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Test substance caused necrosis
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: ciliar injection
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
the readings at 48 hours, 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 8 days
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
14 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
other: the readings at 48 h, 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
the readings at 48 hours, 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 8 days
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
14 d
Remarks on result:
not determinable
Remarks:
the readings at 8 and 14 days were due to suppuration not possible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 8 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
14 d
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 8 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
14 d
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 8 days
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
14 d
Score:
3
Max. score:
3
Reversibility:
not reversible

Table 1

 Animal 1/2/3  24 h  48 h  72 h  8 days  14 days            
A) corneal opacity  2/2/2  2/x/3  3/3/3  x/x/4   x/x/4
B) area  4/4/4  4/x/4  4/4/4  x/x/4   x/x/4
 a = AxBx5  40/40/40  40/-/60  60/60/60  -/-/-   -/-/-
           
 Iris  1/1/1  1/x/1  1/1/1  x/x/x   x/x/x
 b = Ax5  5/5/5  5/-/5  4/4/4  -/-/-   -/-/-
         

 Conjunctiva

 

 

 

 

 

 A) erythema

 2/2/2

 2/x/2

 2/2/2

 x/x/3

  x/x/3

 B) chemosis

 2/2/2

 2/3/3

 2/3/3

 3/3/3

  3/3/3

 C) secretion

 1/1/1

 3/3/3

 3/3/3

 3/3/3

  3/3/3

 c = (A+B+C)x2

 10/10/10

 14/12/16

 14/16/16

 -/-/-

  -/-/-

 

 

 

 

 

 

 Sum=a+b+c

  55/55/55  59/12/81  79/81/81 -/-/-    -/-/-

x: reading due to suppuration not possible.

The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h cliliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h cliliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.
Trimethylamine (aqueous solution): Skin Corr. 1B, H314: Causes severe skin burns and eye damage
Trimethylamine (gaseous form): Eye damage 1, H318: Causes serious eye damage
Executive summary:

A Draize test was performed on 3 rabbits (Vienna White) by BASF (1979). One single application was done with 100 µL, the eyes were not washed out afterwards. The test duration was 14 days. The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h ciliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

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.

BASF AG investigated in 1960 the skin irritation as described: two animals were treated for 1, 5 min and 15 min with trimethylamine (application site of 2.5 x 2.5 cm²). After the application time the skin was washed with 50 % Lutrol. The animals were observed for 26 days and skin changes were recorded. The report describes findings after 24 hours, 48 hours and after 72 hours. The 1 min exposure caused marked oedema and haemorrhagic areas on the day of application which remained almost unchanged for 1 week, at the end of the observation period of 26 days, scar formation could be noted. The 5 and 15 min exposure the treatment resulted in a red-brown necrosis of leather-like consistency on the day of application, then development of a hard crust, and scar formation after 3 weeks. Additionally they tested a 20 % TMA solution in olive oil and the skin effects were less pronounced, this is indicating that the concentration of the liquid formulation which is used on the skin is of great importance to evaluate its potential irritation or corrosive character.

Eye irritation

For eye irritation a Draize test was performed on 3 rabbits (Vienna White) by BASF (1979). One single application was done with 100 µL, the eyes were not washed out afterwards. The test duration was 14 days. The application of the test substance caused red-brown discoloration of the mucous and nictating membrane. After 24 h ciliar injection was noted in all 3 animals. After 8 days severe corneal opacity was noted in 1 animal. Due to purulent exsudate in the other two animals the corneal opacity score was not possible to determine.

Respiratory irritation

In nasal irritation and pulmonary toxicity study of 20 aliphatic amines in mice, Gagnaire et al. exposed mice to airborne TMA to determine RD50 value (Gagnaire et al., 1989, see 7.9.3. Endpoint)). This value indicates 50% decrease in the respiratory rate and considered to be successfully used to predict safe industrial exposure. The onset of action of TMA was very rapid, ca. 30 sec. to 1 min. 61 ppm of TMA was determined as RD50 in mice. At the end of a 15 -min exposure period, the recovery of respiratory frequencies to the pre-exposure values was also rapid, ca.1 min. Due to the rapid recovery of respiratory frequency in mice, trimethylamine is considered to be moderately irritating to the upper respiratory airways.


Effects on skin irritation/corrosion: corrosion

Effects on eye irritation: corrosion

Effects on respiratory irritation: irritation

Justification for classification or non-classification

For Trimethylamine Classification and labelling for irritation/corrosion is warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008:

GHS Classification & Labeling for Trimethylamine (aqueous solution): Skin Corr. 1B, H314: Causes severe skin burns and eye damage, STOT SE 3, H335: May cause respiratory irritation.

GHS Classification & Labeling for Trimethylamine (gaseous form): Skin Irrit. 2 , Eye Dam. 1, H315: Causes skin irritation, H318: Causes serious eye damage, STOT SE 3, H335: May cause respiratory irritation.