Registration Dossier
Registration Dossier
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EC number: 259-701-7 | CAS number: 55542-27-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Dec 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported 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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- 3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one
- EC Number:
- 259-701-7
- EC Name:
- 17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one
- Cas Number:
- 55542-27-3
- Molecular formula:
- C22H34O3
- IUPAC Name:
- 17 beta-Hydroxy-17 alpha-(3-hydroxypropyl)-4-androsten-3-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 57797
- Batch No: 59012052, white powder
- Purity: approx. 91.2% (DC)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 0.5% (m/v) solution of Tylose MH 1000 in distilled water
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Applicant's summary and conclusion
- Executive summary:
The single dermal administration of the test substance (ZK 57797) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality, clinical signs, body weight changes or pathological findings.
The acute dermal toxicity of Hydroxypropyltesto in rats is therefore above 2000 mg/kg body weight.
Moreover, no compound-related local findings were observed. None of the animals showed alterations of the skin (edema and/or erytthema) on the administration area.
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