Registration Dossier

Administrative data

Description of key information

DMEA is corrosive for the skin and the eyes and irritating for the respiratory tract.

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

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: BASF-Test. 50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.58 and 3.28 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: he adjacent eye served as control treated with 0.9 % NaCl (saline).
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
0.25
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: In one animal iritis was induced. 72 h reading is missing.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
0.5
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: 72 h reading is missing

Findings: animal1/animal2

 Time  opacity  iritis  erythema chemosis        
 1 h 3/2 0/0 0/0 2/2        
 24 h 3/3 0/0 0/1 2/1          
 48 h 3/3 0/1 0/1 2/1          
 72 h -/- -/- -/- -/-          
 8 d 3/- 0/2  0/0 2/0          

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Mean values over 24 and 48 h (72 h reading is missing).

Animal1: Opacity: 3, Iritis: 0, Erythema: 0, Chemosis: 2;

Animal2: Opacity: 3, Iritis: 1, Erythema: 1, Chemosis: 1;

The substance led to severe corneal opacity. After 5 days heavy purulent exsudate was noted. At the end of the observation period after 8 days, one animal developed iritis. Severe corneal opacity and iritis are considered to be irreversible effects to ophthalmic tissue.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under these experimental conditions, DMEA was found to be corrosive when administered by ocular route to rabbits.
Executive summary:

The potential of Dimethylethylamine (DMEA) to induce ocular irritation was evaluated in Vienna White rabbits according to a protocol comparable to the OECD No 405. 50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours. The animals were observed for 8 days.

At 24 and 48 h, the corneal score was 3, the iris score was 2, the chemosis score was 1.5 and the conjunctival score was 0.5. No reversibility was observed for crone and iris.

Under these experimental conditions, DMEA was found to be corrosive when administered by ocular route to rabbits.

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: study well documented, meets accepted scientific principles, acceptable for assessment
Qualifier:
according to
Guideline:
other: Journal Officiel Francais, arrêté du 5 avril 1971
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: To: no data
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
24, 48, 72, 96 hours and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize scoring scale
cornea: AxBx5
Iris: Ax5
Conjonctiva: (A+B+C)x2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: Not readable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.61
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Histology: DMEA induced an acute uveitis with acute keratitis

Reading

 

Rabbit

Mean

1

2

3

4

5

6

24hours

Cornea

4

4

4

4

4

4

84.3/100

4

3

4

4

3

4

Iris

-

-

-

-

-

-

Conjunctive

3

3

3

3

3

3

1

0

1

1

1

1

1

0

2

3

2

2

 

48hours

Cornea

4

4

4

4

4

4

95.3/100

4

4

4

4

4

4

Iris

-

-

-

-

-

-

Conjunctive

3

3

3

3

3

3

2

1

1

2

2

2

3

3

3

3

3

3

 

72hours

Cornea

4

4

4

4

4

4

96.7/100

4

4

4

4

4

4

Iris

-

-

-

-

-

-

Conjunctive

3

3

3

3

3

3

3

3

2

3

1

2

3

3

3

3

3

3

 

96hours

Cornea

4

4

4

4

4

4

96.7/100

4

4

4

4

4

4

Iris

-

-

-

-

-

-

Conjunctive

3

3

3

3

3

3

3

3

2

3

1

2

3

3

3

3

3

3

 

7days

Cornea

4

4

4

4

4

4

95.3/100

4

4

4

4

4

4

Iris

-

-

-

-

-

-

Conjunctive

3

3

2

3

3

3

3

3

1

3

1

2

3

3

1

3

3

3

 

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under these experimental conditions, the substance DMEA (dimethylethylamine) has to be considered as corrosive.
Executive summary:

The acute eye irritation of Dimethylethylamine (DMEA) was evaluated in rabbits according to the “Journal Officiel Français arrêté du 05 avril 1971”. 0,1mL of DMIPA was applied in the right eye and the reaction was observed 24, 48, 72, 96 hours and 7 days after administration.

Iris has never been examined because of the total corneal opacity from 24 hours. Maximal scores are recorded until the day7.

Under these experimental conditions, DMEA has to be classified as corrosive.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

The acute dermal irritation of Dimethylethylamine (DMEA) was evaluated in Vienna White rabbits (BASF 1973). 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.

The acute dermal irritation of Dimethyethylamine (DMEA) was also evaluated in rabbits according to the “Journal Officiel Français, arrêté du 05 avril 1971 ” (Truhaut, 1976). 0.5 mL of DMIPA was applied during 24 hours in 6 rabbits on intact or scarified skin. The cutaneous reaction was observed 24 or 72 hours after the beginning of the application.

After application of the substance during 24 hours, the calculated erythema and edema scores were 1 and 0.67 for intact skin and 2.75 and 2.75 for abraded skin, respectively. Under these experimental conditions, DMEA has to be classified as mild irritant.

Eye irritation

The acute eye irritation of Dimethylethylamine (DMEA) was evaluated in rabbits according to the "Journal Officiel Français arrêté du 05 avril 1971" (Truhaut 1976). Iris has never been examined because of the total corneal opacity from 24hours. Maximal scores are recorded until the day 7. Under these experimental conditions, DMEA has to be classified as corrosive.

The potential of Dimethylethylamine (DMEA) to induce ocular irritation was also evaluated in Vienna White rabbits according to a protocol comparable to the OECD No 405 (BASF 1973). 50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours. The animals were observed for 8 days.

At 24 and 48 h, the corneal score was 3, the iris score was 2, the chemosis score was 1.5 and the conjunctival score was 0.5. No reversibility was observed for crone and iris.

Under these experimental conditions, DMEA was found to be corrosive when administered by ocular route to rabbits.

Respiratory tract irritation

The nasal irritation produced by Dimethylethylamine was studied using male Swiss OF1mice. Groups of six mice each were exposed to concentrations of DMEA ranging from 84 to 216 ppm in air for 15 min to determine the concentration at which the respiratory rate was decreased by 50% (RD50) (Gagnaire et al., 1989). The head of each mouse was isolated in an inhalation chamber, and the breathing frequency was measured with a pressure transducer before and during the exposure period. The RD50for Diisopropylamine was 161 ppm, and maximal effects were observed within 0.5 to 1 min.The authors also exposed groups of mice to 251 to 610 ppm of DMEA via tracheal cannulation for 120 min. The concentration that caused a 50% decrease in respiratory rate via this route (RD50TC) was 691 ppm.

Justification for classification or non-classification

Regulation (EC) No 1272/2008, Annex VI Table 3.1

Corrosive (category 1B, Causes severe skin burns and eye damage)

Self-classification according to EC Regulation 1272/2008 and GHS criteria

Corrosive (category 1A, Causes severe skin burns and eye damage)

Eye Damage (category 1, Causes serious eye damage.)

Specific target organ toxicity after single exposure (category 3, May cause respiratory irritation)