3-(dimethylamino)propylurea

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

This study was designed to comply with the standards set forth in OECD Guidelines For Testing Chemicals, Number 405, adopted February 24, 1987.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(dimethylamino)propylurea

EC Number:

401-950-2

EC Name:

3-(dimethylamino)propylurea

Cas Number:

31506-43-1

Molecular formula:

C6H15N3O

IUPAC Name:

[3-(dimethylamino)propyl]urea

Constituent 2

Reference substance name:

Oxydipropanol

EC Number:

246-770-3

EC Name:

Oxydipropanol

Cas Number:

25265-71-8

Molecular formula:

C6H14O3

IUPAC Name:

1,1'-oxydipropan-1-ol

Constituent 3

Reference substance name:

1,3-bis[3-(dimethylamino)propyl]urea

EC Number:

257-861-2

EC Name:

1,3-bis[3-(dimethylamino)propyl]urea

Cas Number:

52338-87-1

Molecular formula:

C11H26N4O

IUPAC Name:

1,3-bis[3-(dimethylamino)propyl]urea

Constituent 4

Reference substance name:

Urea

EC Number:

200-315-5

EC Name:

Urea

Cas Number:

57-13-6

Molecular formula:

CH4N2O

IUPAC Name:

urea

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand White rabbits were received from Ace Animals, Boyertown, PA on 12/21/99 and quarantined for at least five days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animal were examined according to the Draize technique for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva.
A Mini-Maglite flashlight equipped with a high intensity bulb was used to aid in the examination. Three rabbits (males), free from evidence of ocular irritation or abnormalities, were assigned to this study.
The animals were born the weeks of 10/10 through 10/24/99. The pretest body weight was 2.1 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed llcage in suspended cages. Bedding was placed beneath the cages and changed at least three times week. Fresh Purina Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour lightldark cycle and was kept clean and vermin free.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

One eye of each rabbit was dosed. The contralateral eye sewed as a control. The test article (0.1 ml) was placed by syringe into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test article.

Duration of treatment / exposure:

Using a Mini-Maglite flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48, and 72 hours post dose and on day 7.
Ocular reactions were graded according to the numerical Draize technique. Additional signs were described.

Observation period (in vivo):

1, 24, 48, and 72 hours post dose and on day 7

Number of animals or in vitro replicates:

Three healthy New Zealand White rabbits (males)

Details on study design:

Three healthy New Zealand White rabbits (males), free from evidence of ocular initation and corneal abnormalities, were dosed with NE 1060. The test article (0.1 ml) was placed into the conjunctival sac of one eye of each rabbit. The eyes were examined and scored by the Draize technique at 1,24,48 and 72 hours post dose and on day 7. The primary eye irritation score for each rabbit, each day, was calculated. Body weights were recorded pretest

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 65 - <= 85

Max. score:

85

Reversibility:

not reversible

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

24/48/72 h

Score:

63

Max. score:

63

Reversibility:

not reversible

Results 3

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 38 - <= 63

Max. score:

63

Reversibility:

not reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 40 - <= 60

Max. score:

60

Reversibility:

not reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

40

Max. score:

40

Reversibility:

not reversible

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 15 - <= 40

Max. score:

40

Reversibility:

not reversible

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

5

Max. score:

5

Reversibility:

not reversible

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

5

Max. score:

5

Reversibility:

not reversible

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

5

Max. score:

5

Reversibility:

not reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 18 - <= 20

Max. score:

20

Reversibility:

not reversible

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

18

Max. score:

18

Reversibility:

not reversible

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

18

Max. score:

18

Reversibility:

not reversible

Irritant / corrosive response data:

Corneal opacity, iritis and conjunctival irritation persisted through day 7.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

NE 1060 is corrosive

Executive summary:

Corneal opacity, intis and conjunctival irritation persisted through day 7. One instance of soiling of the anogenital area was noted during the observation period.

Conclusion: NE 1060 is corrosive.