Registration Dossier
Registration Dossier
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EC number: 212-686-0 | CAS number: 846-48-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 27. Jan to 23. Feb 2010
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Boldenone
- EC Number:
- 212-686-0
- EC Name:
- Boldenone
- Cas Number:
- 846-48-0
- Molecular formula:
- C19H26O2
- IUPAC Name:
- 17-hydroxyandrosta-1,4-dien-3-one
- Details on test material:
- - Name of test material (as cited in study report): boldenone (ZK5320)
- Analytical purity: 99%
- Lot/batch No.: 8145-3/08
- Expiration date of the lot/batch: 11 Jul 2011
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3/sex
- 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
All rats were without any compound-related clinical or macroscopic pathological signs.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 of boldenone > 2000 mg/kg, therefore classification is not required.
- Executive summary:
The single dermal administration of boldenone to male and female rats in the doses of 2000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. LD50 > 2000 mg/kg
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