3-(dimethylamino)-N,N-dimethylpropionamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(dimethylamino)-N,N-dimethylpropionamide

EC Number:

241-304-5

EC Name:

3-(dimethylamino)-N,N-dimethylpropionamide

Cas Number:

17268-47-2

Molecular formula:

C7H16N2O

IUPAC Name:

3-(dimethylamino)-N,N-dimethylpropanamide

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Male or female Hew Zealand White rabbits

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid).

Duration of treatment / exposure:

One application

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored by the attached system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

7 d

Score:

0.8

Max. score:

1

Reversibility:

not specified

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

14 d

Score:

1.3

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

21 d

Score:

1

Max. score:

3

Reversibility:

not specified

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Max. score:

3

Reversibility:

not specified

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

7 d

Score:

1.2

Max. score:

2

Reversibility:

not specified

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

14 d

Score:

0.5

Max. score:

1

Reversibility:

not specified

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

21 d

Score:

0.5

Max. score:

1

Reversibility:

not specified

Results 9

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 10

Irritation parameter:

iris score

Basis:

mean

Time point:

14 d

Score:

0.3

Max. score:

1

Reversibility:

not specified

Results 11

Irritation parameter:

iris score

Basis:

mean

Time point:

21 d

Score:

0.2

Max. score:

1

Reversibility:

not specified

Results 12

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

0.5

Max. score:

1

Reversibility:

not specified

Results 13

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Results 14

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

7 d

Score:

1.5

Max. score:

2

Reversibility:

not specified

Results 15

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

14 d

Score:

0.7

Max. score:

2

Reversibility:

not specified

Results 16

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

21 d

Score:

0.8

Max. score:

2

Reversibility:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Persistent, minor, diffuse corneal opacity in 6 of 6 eyes, iritis in 6, moderate to severe conjunctival irritation in 6 from 0.005 ml; conjunctival necrosis, instances of corneal vascularization observed; 3 healed, 3 still injured at 21 days.