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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - July 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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (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:
Tert-butyl 3-oxoazetidine-1-carboxylate
EC Number:
627-725-0
Cas Number:
398489-26-4
Molecular formula:
C8H13NO3
IUPAC Name:
Tert-butyl 3-oxoazetidine-1-carboxylate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch Nr. : RC10050008
Purity : 99.44%
Retest date : 22 June 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:
LD50
Effect level:
ca. 2 500 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to OECD test guideline 423 the acute oral median lethal dose (LD50) of PAM-Azetidinone, CAS No. 398489-26-4 in the female Wistar rat
was estimated to be 2500 mg/kg body weight (Globally Harmonized Classification System - Category 5, > 2000 - 5000 mg/kg body weight).
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the PAM-Azetidinone in the Wistar strain rat.

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 of 2000 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.

One animal treated at a dose level of 2000 mg/kg was killed for humane reasons, during the day of dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths at a dose level of 300 mg/kg.

Clinical Observations.

Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, ataxia and pilo-erection. Additional signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were prostration, labored respiration, decreased respiratory rate and coma. There were no signs of systemic toxicity noted in the initial three animals treated at a dose level of 2000 mg/kg and animals treated at a dose level of 300 mg/kg.

Body Weight.

Surviving animals showed expected gains in body weight.

Necropsy.

Abnormalities noted at necropsy of the animal that was humanely killed were yellow colored liquid present in the stomach and haemorrhage and epithelial sloughing of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.