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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
March 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (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:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
EC Number:
610-201-0
Cas Number:
446292-08-6
Molecular formula:
C22 H19 N3 O6
IUPAC Name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
Details on test material:
Oxaphthalimid, off-white powder, Batch BXR34BR, content: 99.8%

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tap water with the aid of 2% Cremophor EL
Doses:
2000 mg/kg with an administration volume of 10 ml/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

A dose of 2000 mg/kg was tolerated by females without mortalities, toxicological effects on body weight and body weight gain and gross pathological findings. No clinical signs were observed.

 Dose mg/kg  Toxicological result*  Occurence of signs  Time of death  Mortality (%)
 (1st) 2000  0 / 0 / 3  --  --  0
 (2nd) 2000  0 / 0 / 3 --  --  0

* Number of animals which died spontaneously and/or were sacrificed in moribund state / Number of animals with signs of toxicity / Total number of animals used per group

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity to female Wistar rats of Oxaphthalimid was assessed. The test compound was formulated in tap water with the aid of 2% Cremophor EL, the administration volume was 10 ml/kg body weight.

According to the OECD guideline 423 the LD50 cut-off of Oxaphthalimid in female rats is 5000 mg/kg (Category 5 of the GHS System).