Registration Dossier
Registration Dossier
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EC number: 223-768-0 | CAS number: 4062-46-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate
- EC Number:
- 223-768-0
- EC Name:
- 17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate
- Cas Number:
- 4062-46-8
- Molecular formula:
- C22H34O3
- IUPAC Name:
- 1-methyl-3-oxoandrostan-17-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): 17beta-acetoxy-1alpha-methyl-5alpha-androstan-3-one
- Lot/batch No.: 21601607
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, untreated left eye
- Duration of treatment / exposure:
- substance was not removed from the eye
- Observation period (in vivo):
- Observation before application, 0.5, 1 and 2 hours thereafter an then every 24 hours until day 4 of test
- Number of animals or in vitro replicates:
- 2/sex
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- values of findings relevant for classification 24, 48 and 72 hours after application were 0 for cornea, iris and conjunctival swelling and 0.3 for conjunctival reddening.
- Time point:
- other: 24, 48 and 72 hours
- Reversibility:
- fully reversible
- Other effects:
- slight to moderatesecretion, reddening of teh outer eyelids and eye closure as well as slight to moderatre reddening, swelling and vascular injection of the conjuctivae mainy on the application day. From day 2 to 3 onwards, all animals were without findings.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- no eye irritant
- Executive summary:
Mesterolone acetate (ZK 5894) provoked slight to moderate transient irritations (secretion; reddening of outer eyelids and eyelid closure; reddening, swelling and vascular injection of the conjunctivae) in the rabbit eye after single conjunctival application on the day of administration. From day 3 onwards, all animals were without findings. Mesterolone acetate is not regarded as an eye irritant.
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