Registration Dossier
Registration Dossier
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EC number: 207-355-2 | CAS number: 464-49-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
Test material
- Reference substance name:
- Bornan-2-one
- EC Number:
- 200-945-0
- EC Name:
- Bornan-2-one
- Cas Number:
- 76-22-2
- Molecular formula:
- C10H16O
- IUPAC Name:
- 1,7,7-trimethylbicyclo[2.2.1]heptan-2-one
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- 7 days/week, 13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600mg/kg/d, 120mg/kg/d, 25mg/kg/d, 0mg/kg/d
Basis:
nominal in diet
- No. of animals per sex per dose:
- 12 females, 12 males
Examinations
- Observations and examinations performed and frequency:
- observe the performances envey morning and afternoon
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- organ coefficient is increased in spleen, kidney and brain
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 3.2 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 9.9 mg/kg bw/day (nominal)
- System:
- hepatobiliary
- Organ:
- brain
- heart
- kidney
- liver
- spleen
- Treatment related:
- yes
- Dose response relationship:
- yes
Applicant's summary and conclusion
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