Ethanone, 2,2-dichloro-1-(2,3-dihydro-3-methyl-4H-1,4-benzoxazin-4-yl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 February 1986 to 20 February 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one

EC Number:

619-372-6

Cas Number:

98730-04-2

Molecular formula:

C11H11Cl2NO2

IUPAC Name:

2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Groups of 5 male and 5 female young adult Sprague Dawley rats.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The test article was dissolved in 1% carboxy methylcellulose and a volume of 50 ml/kg was administered.

Doses:

0, 100, 500, 1000, 2500, or 5000 mg/kg CGA154281

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The animals were observed for 14 days and deaths, clinical signs and body weights were recorded.

Statistics:

Not reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: based on 20% mortality in males (only) at 5000 mg/kg

Mortality:

One male dosed with 5000 mg/kg died on day 4.

Clinical signs:

other: Signs of systemic toxicity were observed at dose levels > 500 mg/kg and included hypoactivity, perineal staining, soft feces, and squinting. At dose levels > 2500 mg/kg, chromodacryorrhea, staining around the mouth and few feces were noted additionally. A

Gross pathology:

At necropsy, no treatment-related findings were observed.

Any other information on results incl. tables

There were no clinical findings at 100 mg/kg. Clinical signs of toxicity were apparent at doses of 500 mg/kg or greater. At the high dose 5000 mg/kg one of five males died (20% mortality). There were no other deaths.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the LD50 was determined to be greater than 5000 mg/kg.

Executive summary:

Single oral doses of 100, 500, 1000, 2500 or 5000 mg/kg of benoxacor (CGA154281) were administered by gavage to groups of 5 male and 5 female rats. There were no clinical signs at 100 mg/kg. Signs of toxicity were apparent at doses of 500 mg/kg or greater. One of five males died at the 5000 mg/kg dose level. There were no other mortalities. The median lethal dose was greater than 5000 mg/kg in both sexes. Benoxacor was considered to be of low toxicity when given as a single oral dose to rats.