Registration Dossier
Registration Dossier
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EC number: 618-311-0 | CAS number: 898543-06-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one hydrochloride
- EC Number:
- 618-311-0
- Cas Number:
- 898543-06-1
- Molecular formula:
- C14 H17 N3 O4 . Cl H
- IUPAC Name:
- 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one hydrochloride
Constituent 1
- Specific details on test material used for the study:
- Batch BXR2B06
purity: 100%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 Kißlegg, Germany, 69592
- Age at study initiation: young adult animals
- Weight at study initiation: 3.085 kg — 3.530 kg
- Housing: The animals were housed individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): The animals received the standard diet “SsniffK-Z” 4mm (manufacturer: Ssniff Spezialdiäten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other:
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 1h
SCORING SYSTEM: According to DRAIZE
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: not reported
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Results of the study
| Irritant Effects (Score) | |||||
| Animal | 24 h | 48 h | 72 h | Mean scores | |
| 1 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iritis | 0 | 0 | 0 | 0.0 | |
| Redness conjunctivae | 1 | 0 | 0 | 0.3 | |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
| 2 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iritis | 0 | 0 | 0 | 0.0 | |
| Redness conjunctivae | 1 | 0 | 0 | 0.3 | |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
| 3 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iritis | 0 | 0 | 0 | 0.0 | |
| Redness conjunctivae | 0 | 0 | 0 | 0.0 | |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
All animals showed reddening of the conjunctivae (grade 2), chemosis (grade 1) and lacrimation (grade 1) 1 h after administration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is not an irritant to eyes
- Executive summary:
0.1 g of the test substance was administered into the conjunctival sac of in each case one rabbit eye of 3 females and after 1 h the treated eyes were washed.
Evaluation of eye irritation was made according to Draize.
According to the classification criteria (S)-Oxamin Hydrochlorid is not irritating to eyes.
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