Registration Dossier

Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Journal Officiel Francais, arrêté du 5 avril 1971
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-dimethylethylamine
- Physical state: liquid
- Analytical purity: 99.5%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: origin: UGINE KUHLMANN

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.