Methylurea

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methylurea

EC Number:

209-935-0

EC Name:

Methylurea

Cas Number:

598-50-5

Molecular formula:

C2H6N2O

IUPAC Name:

methylurea

Details on test material:

- Name of test material (as cited in study report): Methylharnstoff, technisch (methylurea, technical grade)
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight / mean weight at study initiation: 3.12 kg for the male and 3.13 kg for the females
- Housing: 1 animal per cage, stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm.
- Diet (e.g. ad libitum): KLIBA 341, 4 mm, FA. KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, about 130 g per animal per day
- Water: TAP WATER, about 250 ml per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 57 mg of the comminuted test substance was placed into the conjunctival sac of the right eyelid of each animal.

Duration of treatment / exposure:

Single application, not washed out

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 (one male, two females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was not washed out.

READING
- 1, 24, 48, and 72 hour(s) after application.

SCORING SYSTEM:
- according to 83/467/EEC criteria (1983)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal 1 - 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48 , 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

The test substance was not irritating to the eye. Mean irritation scores were 0.44 (cornea), 0.0 (iris), 0.89 (conjunctivae redness), and 0.11 (conjunctivae swelling).
Further observations were small retractions in the eyelid of 2 rabbits.

Other effects:

No other effects.

Any other information on results incl. tables

Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out
Animal	Reading	Cornea Opacity	Iris	Conjunctiva		Additional findings
				Redness	Chemosis
1	1 h	0	0	1	0
2	1 h	0	0	2	1
3	1 h	0	0	2	2
1	24 h	0	0	0	0
2	24 h	1	0	2	0	small retractions in the eyelids
3	24 h	1	0	2	1	small retractions in the eyelids
1	48 h	0	0	0	0
2	48 h	1	0	2	0	small retractions in the eyelids
3	48 h	1	0	2	0	small retractions in the eyelids
1	72 h	0	0	0	0
2	72 h	0	0	0	0	small retractions in the eyelids
3	72 h	0	0	0	0	small retractions in the eyelids
mean animal 1	24 - 72 h	0.00	0.00	0.00	0.00
mean animal 2	24 - 72 h	0.67	0.00	1.33	0.00
mean animal 3	24 - 72 h	0.67	0.00	1.33	0.33
mean total	24 - 72 h	0.44	0.00	0.89	0.11

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information