Registration Dossier
Registration Dossier
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EC number: 296-665-1 | CAS number: 92908-36-6
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Urea, reaction products with formaldehyde, glyoxal and methanol
- EC Number:
- 296-665-1
- EC Name:
- Urea, reaction products with formaldehyde, glyoxal and methanol
- Cas Number:
- 92908-36-6
- Molecular formula:
- C2 H2 O2 .C H4 N2 O .C H4 O .C H2 O
- IUPAC Name:
- Urea, reaction products with formaldehyde, glyoxal and methanol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 000161MCA0
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A.; Vonnas, France
- Age at study initiation: 6 -7 months
- Weight at study initiation: 4.12 kg - 4.37 kg
- Housing: single housing
- Diet (e.g. ad libitum): Klinab-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP")
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- In addition injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
||||
1 h |
01 |
0 |
0 |
0 |
1 |
2 |
2 |
49 |
02 |
0 |
0 |
0 |
1 |
1 |
1 |
48 |
|
03 |
0 |
0 |
0 |
0 |
2 |
2 |
49 |
|
24 h |
01 |
0 |
0 |
0 |
1 |
0 |
0 |
48 |
02 |
0 |
0 |
0 |
1 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
0 |
0 |
1 |
48 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
1 |
0 |
0 |
48 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
|
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean 24 – 72 h |
01 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
02 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
|
03 |
0.0 |
|
0.0 |
1.0 |
0.0 |
|
|
|
Mean |
|
0.0 |
|
0.0 |
0.6 |
0.0 |
|
|
48 = scleral vessels injected, circumscribed area
49 = scleral vessels injected, circular
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, Fixapret CL, PBG = 10003635, after Concentration does not show an eye irritation potential under the test conditions chosen.
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