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EC number: 200-315-5 | CAS number: 57-13-6
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 August to 14 September 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Proprietary guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Details on test material:
- "Harnstoff Techn." (urea)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- The animals were 1 male and 2 female Vienna White rabbits, obtained from Gaukler. The male rabbit weighed 2.45 kg and the mean weight of the females was 2.74 kg. They were housed individually in stainless steel cages with wire mesh floors. Individuals were identified by ear tattoo. The rabbits were housed in air conditioned rooms, the temperature was maintained at 20-24°C and relative humidity was 30-70%. Light was provided on a 12 hour light/dark cycle. The rabbits were fed approximately 130 g/day of Kliba 341. 4 MM (Firma Klingentalmuehle AG, Switzerland), and provided with approximately 250 ml tap water per day. The rabbits were acclimatised for 8 days.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL bulk volume (about 43 mg powdered substance).
- Duration of treatment / exposure:
- Single application, the substance was not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- 0.1 mL bulk volume of the substance was administered in a single application to the conjunctival sac of the right eye of each rabbit, the substance was not washed out. The left eye remained untreated to act as a negative control. Irritation readings were made at 1, 24, 48, 72 hours and 8 days after application. Reactions were scored according to OECD guidelines.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- At 1 hour after application all irritant effects were limited to the conjunctivae. At 24 hours there were corneal effects in 2 rabbits, and irritation of the iris and conjunctivae in all 3 rabbits; 2 rabbits displayed small retractions of the eyelids, 2 rabbits displayed contracted pupils and 2 rabbits exhibited a loss of corneal tissue. At 48 hours 1 rabbit was also exhibiting suppuration and bloody discharge from the eye. 8 days after treatment all rabbits were given scores of 0 for all irritative parameters, 1 rabbit was still displaying small retractions of the eyelids. Individual data are presented in Table 1.
- Other effects:
- None reported.
Any other information on results incl. tables
Table 1. Individual animal data.
Time |
Rabbit No. Sex |
Cornea |
Iris |
Conjunctivae |
Symptoms |
|||
OP |
AR |
RED |
CH |
DI |
||||
1 h |
1 F |
0 |
0 |
0 |
2 |
2 |
2 |
|
2 M |
0 |
0 |
0 |
2 |
2 |
1 |
|
|
3 F |
0 |
0 |
0 |
2 |
2 |
2 |
|
|
24 h |
1 F |
0 |
0 |
1 |
3 |
2 |
2 |
RE |
2 M |
1 |
2 |
1 |
2 |
2 |
2 |
RE/PC/LC |
|
3 F |
1 |
3 |
1 |
3 |
1 |
1 |
PC/LC |
|
48 h |
1 F |
1 |
1 |
0 |
2 |
1 |
1 |
RE |
2 M |
1 |
2 |
1 |
2 |
2 |
2 |
LC/PC/RE/S/DB |
|
3 F |
1 |
2 |
0 |
2 |
0 |
0 |
LC/PC |
|
72 h |
1 F |
1 |
1 |
0 |
2 |
0 |
0 |
RE |
2 M |
1 |
1 |
0 |
2 |
1 |
1 |
LC/PC/RE |
|
3 F |
1 |
1 |
0 |
2 |
0 |
0 |
LC |
|
8 d |
1 F |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 M |
0 |
0 |
0 |
0 |
0 |
0 |
RE |
|
3 F |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean |
1 F |
0.7 |
0.3 |
2.3 |
1.0 |
|
|
|
2 M |
1.0 |
0.7 |
2.0 |
1.7 |
|
|
||
3 F |
1.0 |
0.3 |
2.3 |
0.3 |
|
|
OP = Opacity, AR = Area involved
RED = Redness, CH = Chemosis, DI = Discharge
RE = small retractions in eyelids
PC = pupil contracted
LC = loss of corneal tissue
S = suppuration
DB = discharge of blood
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Urea is mildly irritating to eyes
- Executive summary:
The eye irritation potential of urea was determined in 3 Vienna White rabbits. The substance was administered in a single application to the right conjunctival sac of each rabbit; the substance was not washed out. The degree of corneal opacity, iris irritation and conjunctival irritation (redness, swelling and discharge) were scored at 1, 24, 48, 72 hours and 8 days after application. Well defined to severe redness and slight to well defined swelling of the conjunctivae was seen in all rabbits. Slight opacity of the cornea was seen in 2 rabbits at 24 hours and all rabbits at 48 and 72 hours. Other signs observed included small retractions in eyelids, contracted pupil and loss of corneal tissue. Circumcorneal injection was observed in all rabbits at 24 hours and remained in 1 rabbit at 48 hours. One rabbit (male) also exhibited suppination and bloody discharge 48 hours after application. All signs of irritation had disappeared 8 days after application. The test substance can be classified as mildly irritating to eyes.
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