Registration Dossier
Registration Dossier
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EC number: 200-370-5 | CAS number: 58-22-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 23. Feb to 22. March 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP study with acceptable restrictions
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:
- other: see principles of method
- Principles of method if other than guideline:
- Combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.3 ml) to male and female rats; occlusive conditions; exposure for 24 hours; values for reddening, scab formation and swelling obtained immediately after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- 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
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- physiological saline
- Controls:
- no
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30-60 min, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- none
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 the read-across substance, androstenedione
- Executive summary:
There are no available skin 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 did not show a skin irritating or corrosive potential in rats when administered semi-occlusively to the back for 24 hours.
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