Registration Dossier
Registration Dossier
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EC number: 200-370-5 | CAS number: 58-22-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Androst-4-ene-3,17-dione
- EC Number:
- 200-554-5
- EC Name:
- Androst-4-ene-3,17-dione
- Cas Number:
- 63-05-8
- Molecular formula:
- C19H26O2
- IUPAC Name:
- androst-4-ene-3,17-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- substance was not flushed out, application of 0.1 ml substance only into the right eye
- Observation period (in vivo):
- 0.5, 1, 2, h after application and then every 24 h until day 4 of test
- Number of animals or in vitro replicates:
- 4 animals
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- ZK 5155 provoked slight to moderate transient irritations (vessel injection and secreation in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testosterone is not classified according to Directive 67/548/EEC and Regulation 1272/2008/EC (CLP) criteria, based on no irritating potential in vivo of read-across substance androstenedione.
- Executive summary:
There are no available eye irritation studies on testosterone. Results of a study conducted with a structurally similar compound (androstenedione, ZK5155) are reported and used for read-across.
ZK 5155 provoked slight to moderate transient irritations (vessel injection and secretion in 2/4 animals) on the rabbit eye after single interconjunctival application on the day of administration. ZK5155 is not regarded as an eye irritant.
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