3-Morpholinone, 4-phenyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

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:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-phenylmorpholin-3-one

EC Number:

608-371-6

Cas Number:

29518-11-4

Molecular formula:

C10 H11 N O2

IUPAC Name:

4-phenylmorpholin-3-one

Details on test material:

4-Phenyl-3-morpholinon, white powder, Batch BXR2Z1A, purity 100.5%

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 weight gain and gross pathological findings.

The clinical signs were decreased motility, uncoordinated gait, narrowed palpebral fissure, closed eyelids, abdominal position, labored breathing, pallor, poor reflexes and decreased reactivity.

Dose mg/kg	Toxicological result*	Occurence of signs	Time of death	Mortality (%)
(1st) 2000	0 / 3 / 3	5 min - 6 h	--	0
(2nd) 2000	0 / 3 / 3	20 min - 6 h	--	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 4 -Phenyl-3 -morpholinon 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 4 -Phenyl-3 -morpholinon in female rats is 5000 mg/kg (Category 5 of the GHS System).