Registration Dossier
Registration Dossier
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EC number: 213-552-4 | CAS number: 976-70-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 28. Sep 2000 to 02. Oct 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-oxopregn-4-ene-21,17α-carbolactone
- EC Number:
- 213-552-4
- EC Name:
- 3-oxopregn-4-ene-21,17α-carbolactone
- Cas Number:
- 976-70-5
- Molecular formula:
- C22H30O3
- IUPAC Name:
- (1R,3aS,3bR,9aR,9bS,11aS)-9a,11a-dimethyl-2,3,3a,3b,4,5,7,8,9,9a,9b,10,11,11a-tetradecahydrospiro[cyclopenta[a]phenanthrene-1,2'-oxolane]-5',7-dione
- Details on test material:
- - Name of test material (as cited in study report): aldona (ZK 57564)
- Analytical purity: 95.5% HPLC
- Lot/batch No.: 59035042
- Expiration date of the lot/batch: Aug 2002
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Duration of treatment / exposure:
- 24 h, afterwards eyes were rinsed out with distilled water
- Observation period (in vivo):
- 1, 24, 48 and 72 h after application
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h after application
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no irritation observed
- Other effects:
- One hour after application in two animals slight redness and in one animal clear redness of the conjunctivae of the treated eyes was observed. One rabbit showed also slight swelling of the conjunctivae. 24 hours after instillation all animals were free of any symptoms.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Aldona is not irritating to rabbit eyes. Classifiaction is not required.
- Executive summary:
The acute eye irritation of aldona (ZK 57564) was tested in 3 Albino rabbits. None of the animals showed clinical signs or signs of systemic effects 24 h after instillation. Aldona is no eye irritant.
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