Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
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
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-Hexyl-4-hydroxy-6-undecyl-tetrahydro-pyran-2-one
EC Number:
603-981-9
Cas Number:
136890-12-5
Molecular formula:
C22 H42 O3
IUPAC Name:
3-Hexyl-4-hydroxy-6-undecyl-tetrahydro-pyran-2-one

Test animals

Species:
rat
Strain:
other: Fü-Albino Ibm:RORO
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Standard Solvent Vehicle
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The LD50 of the Orlistat intermediate Ro 18 -8642/000 is greater than 2000 mg/kg bw.