Registration Dossier
Registration Dossier
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EC number: 422-460-5 | CAS number: 137234-87-8 UK-103,442
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1996-06-03 to 1996-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- OJ No. L383A, 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-ethyl-5-fluoro-4(3H)-pyrimidone
- EC Number:
- 422-460-5
- EC Name:
- 6-ethyl-5-fluoro-4(3H)-pyrimidone
- Cas Number:
- 137234-87-8
- Molecular formula:
- C6 H7 F N2 O
- IUPAC Name:
- 6-ethyl-5-fluoro-3,4-dihydropyrimidin-4-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch No.: Chichibu Lot No. 950704
Purity: 95.7%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England.
- Age at study initiation: approximately 12 to 13 weeks
- Weight at study initiation: 2.8 to 3.0 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: A standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Ca 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TREATMENT PROCEDURE
One animal was treated in advance of the others, approximately 100 mg of the test substance, the weight occupying a volume of 0.1 mL, was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Dulling of the normal lustre of the cornea was seen in two animals one hour after instillation. Corneal opacification developed in one of these animals.
No iridial inflammation was seen.
A diffuse crimson to beefy red colouration was seen in all three animals, accompanied in two rabbits by considerable swelling with partial eversion of the eyelids or with the eyelids about half closed.
The reactions gradually ameliorated and the eyes were normal 4, 7 or 14 days after instillation. - Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Individual scores:
Animal No. |
Cornea opacity |
Iris |
Conjunctivae |
Chemosis |
||||||||||||
24 h |
48h |
72 h |
Mean |
24 h |
48 h |
72 h |
Mean |
24 h |
48h |
72 h |
Mean |
24 h |
48h |
72 h |
Mean |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
1.67 |
2 |
1 |
1 |
1.33 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
1.33 |
1 |
1 |
0 |
0.67 |
3 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
3 |
3 |
2 |
2.67 |
2 |
1 |
1 |
1.33 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of test item into the rabbit eye elicited corneal opacification and well-defined to moderate conjunctival irritation.
- Executive summary:
A study was performed to assess the eye irritation potential of test item to the rabbit following the method as described in EC B.5.
Three rabbits were each administered a single ocular dose of 100 mg of the test substance and observed for a maximum of 14 days after instillation.
A single instillation of test item into the eye of the rabbit elicited corneal opacification and well-defined to moderate to severe conjunctival irritation. Responses had resolved in all instances by 14 days after instillation.
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