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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - June 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,5R,8aS)-3-phenyl-3,5,6,7,8,8a-hexahydro-2H-oxazolo[3,2-a]pyridine-5-carbonitrile
EC Number:
634-598-5
Cas Number:
106565-71-3
Molecular formula:
C14H16N2O1
IUPAC Name:
(3S,5R,8aS)-3-phenyl-3,5,6,7,8,8a-hexahydro-2H-oxazolo[3,2-a]pyridine-5-carbonitrile
Test material form:
solid: crystalline
Details on test material:
Identification:P AM -Oxazolopiperidine
CAS number:106565-71-3
Batch:BS12010625
Purity:99.8%
Expiry date:08 November 2013
Storage Conditions:room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted at a dose level of 300 mg/kg during the observation
period.

Hunched posture was noted in all animals treated at a dose level of 2000 mg/kg. Lethargy was
also noted in three animals treated at a dose level of 2000 mg/kg. Animals treated at a dose level
of 2000 mg/kg appeared normal 4 hours or 1 day after dosing.
4.3
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) of the PAM-Oxazolopiperidine in the female Wistar
strain rat was estimated to be greater than 2500 mg/kg body weight (Globally Harmonized
Classification System- Unclassified).
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of PAM-Oxazolopiperidine (CAS number 106565-71-3) in the Wistar strain rat according to OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity- Acute Toxic Class Method" (adopted 17 December 2001).

Methods

A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at a dose level of2000 mg/kg body weight. Dosing was performed sequentially. The test item was administered orally as a solution in dimethyl sulphoxide. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality. There were no deaths.

Clinical Observations. Lethargy and hunched posture were noted in animals treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity noted at a dose level of 300 mg/kg.

Body Weight. All animals showed expected gains in body weight.

Necropsy. No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD5o) of the PAM-Oxazolopiperidine in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

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