Registration Dossier
Registration Dossier
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EC number: 212-686-0 | CAS number: 846-48-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 20. Jan to 16. 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class 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
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- 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 female rats showed increased salivation on administration day. In addition decreased motility, digging and cleaning movements and piloerection were noted on day 1 in 2/3 female animals.
One animal was sacrificed in moribund status on day 6 of the test. The death of this animal was provoked by incidental misapplication.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 of boldenone is > 2000 mg/kg, classification is not required
- Executive summary:
The single oral administration of the boldenone (ZK 5320) to male and female rats at a dose of 2000 mg/kg resulted in increased salivation, decreased motility, digging, cleaning movements and piloerection in 2 out of 3 female animals. One rat was sacrificed in moribund status provoked by incidental misapplication. The acute oral toxicity of boldenome in rats is above 2000 mg/kg body weight.
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