Registration Dossier
Registration Dossier
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EC number: 604-018-5 | CAS number: 137433-01-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientific and detailed study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- (2S,3S,5R)-2-hexyl-3-hydroxy-5-(phenylmethoxy)-Hexadecanoic acid compd. with (S)-α-methylbenzenemethanamine (1:1)
- EC Number:
- 604-018-5
- Cas Number:
- 137433-01-3
- Molecular formula:
- C29 H50 O4 . C8 H11 N
- IUPAC Name:
- (2S,3S,5R)-2-hexyl-3-hydroxy-5-(phenylmethoxy)-Hexadecanoic acid compd. with (S)-α-methylbenzenemethanamine (1:1)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Matota corn oil
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5
- 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.
- Mortality:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The Orlistat intermediate Ro 40 -8168/002 can be classified as a compound which does not present a significant acute toxic risk if swallowed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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