Registration Dossier
Registration Dossier
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EC number: 700-726-4 | CAS number: 1369499-44-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Feb - 24 Jun 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione
- EC Number:
- 700-726-4
- Cas Number:
- 1369499-44-4
- Molecular formula:
- C7H10N2O2
- IUPAC Name:
- (5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 2.2 - 2.3 kg
- Housing: individually
- Diet: ad libitum (ssniff® K-H, ssniff Spezialdiäten GmbH, D-59494 Soest, Germany)
- Water: ad libitum (tap water)
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17.03.2003 To: 19.04.2003
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- 24 hours, single exposure, no washing
- Observation period (in vivo):
- prior to the administration and 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: ophthalmoscopically with a slit lamp
24 hours after administration the eyes were treated additionally with Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 0-79108 Freiburg)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Corneal opacity (grade 1) was observed in animal #3, 24 hours after instillation. Conjunctival redness (grade 1) was observed in animal #2, 1 hour after instillation. Conjunctival chemosis (grade 1) was observed in animal #2, 1 hour after instillation. The iris was not affected by the test item.
All effects were reversible within 48 hours. - Other effects:
- There were no systemic intolerance reactions observed throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test material caused no eye irritating/corrosive reactions. The individual mean values from gradings at 24, 48 and 72 h were 0 - 0.33 for corneal opacity, 0 for iritis, 0 - 0.33 for chemosis and 0 - 0.33 for conjunctival redness. The observed effects were fully reversible within 48 h post-instillation.
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