Registration Dossier
Registration Dossier
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EC number: 700-713-3 | CAS number: 83161-22-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
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
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
- EC Number:
- 700-713-3
- Cas Number:
- 83161-22-2
- Molecular formula:
- C11H22O5
- IUPAC Name:
- (2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
- Details on test material:
- For technical reason (solubility), APRC5 was diluted at 30% in a water/glycerol (1/5) mixture
This mixture corresponds to the industrial form.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water/glycerol mixture
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals per dose
- Control animals:
- no
- Details on study design:
- At the first step, a group of 3 animals was treated with the starting dose of 2000 mg.kg body weight, followed by an additionnal group of 3 animals at the same dose level.
General observation were performed twice on Day 1 (60 min ± 30 min post-dose and again between 3 and 4h post-dose), and then daily for 14 days after administration of the test item. Functional and neurobehavioural tests were performed on Day 1 (60 min ± 30 min post-dose), on Day 7 and on Day 14. Animals were weighted on Days 1, 7, 14 and 15 (day of necroscopy). - Statistics:
- All animals surviving ti the end of the 14-day monitoring period were submitted to gross necroscopy.
Results and discussion
- Preliminary study:
- No mortality was observed
Effect levels
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- No organ or tissue gross findings were seen at necroscopy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality is observed in experimental conditions
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