Registration Dossier
Registration Dossier
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EC number: 605-254-1 | CAS number: 16142-27-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented Guideline-Study, but non-GLP. Only minor deviations or documentation lacks.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-amino-3-(morpholin-4-yl)-1,2,3-oxadiazolidin-3-ium chloride
- EC Number:
- 605-254-1
- Cas Number:
- 16142-27-1
- Molecular formula:
- C6 H11 N4 O2 . Cl
- IUPAC Name:
- 5-amino-3-(morpholin-4-yl)-1,2,3-oxadiazolidin-3-ium chloride
- Test material form:
- solid: crystalline
- Details on test material:
- Batch W003
Purity > 99 %
Molecular formular C6H11ClN4O2
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Germany
- Age at study initiation: no data
- Weight at study initiation: 1841 g +/- 32 g
- Housing: Semibarrier housing. Stainless steel cages with floor grates made of oval steel and feces-collecting pans, 50x55x40 cm. One animal per cage.
- Diet (e.g. ad libitum): Altromin 2123, ad libitum
- Water (e.g. ad libitum): Tab water, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Climate, 20°C +/- 2°C, clim
- Humidity (%): 30-40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours, Light-phase from 6:30 am - 6:30 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: As a control serves a similar, with distilled water. moistened pack (without test substance) on the other shaved area of the skin of the same animal.
- Amount / concentration applied:
- 100 mg/animal
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 6 d
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h - 6 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4-6 d
- Score:
- 0
- Max. score:
- 3
Any other information on results incl. tables
During the test, no animal died. Immediately after administration responded to Tier 1 with lacrimation, Tier 2 for a short time with sounds. One hour after administration all animals revealed lacrimation. In the further course, there were no clinical symptoms.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The single administration of the test substance in the conjunctival sac of albino rabbits, with an exposure time of 24 h led within three days to only a slight redness of the conjunctiva. One animal had a swelling in addition to which, however, declined within 24 h. In the course of examination no evidence of systemic effect of the substance were observed. According to the results of the present study, the test substance can thus be classified as non-irritating to eyes.
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