3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione;famoxadone (ISO)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Test material

Test material information

Constituent 1

Reference substance name:

5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione

EC Number:

603-520-1

Cas Number:

131807-57-3

Molecular formula:

C22H18N2O4

IUPAC Name:

5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione

Test material form:

solid

Specific details on test material used for the study:

Substance ID: DPX-JE874-498
Batch #: JEGX150811
Purity: 98.8%

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 10-11 weeks
- Weight at study initiation: 213.1 to 239.2 g
- Fasting period before study: Yes (approximately 17-17.5 hours prior to dosing)
- Housing: Animals were housed individually in solid-bottom caging with bedding and appropriate species-specific enrichment.
- Diet: ad libitum except during fasting
- Water: ad libitum except during fasting
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-26ºC
- Humidity: 30-70%
- Photoperiod: 12-hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.1% Tween 80 (V/V) in 0.5% methylcellulose

Details on oral exposure:

A single oral dose of test substance, suspended in 0.1% Tween 80 (V/V) in 0.5% methylcellulose, was administered by oral gavage to fasted female rats at a dose level of 5000 mg/kg. The rats were dosed one at a time.

Doses:

5000 mg/kg

No. of animals per sex per dose:

03

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical signs: Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, or abnormal behavior.
- Frequency of observations and weighing: Animals were weighed on test days -1, 1, 8, and 15, and were observed for clinical signs at the beginning of fasting, just before dosing (test day 1), once during the first 30 minutes after dosing and 3 more times on the day of dosing, and once each day thereafter.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: Discolored feces was noted in one animal on the day of dosing (test day 1), which resolved by test day 2.

Gross pathology:

No gross lesions were present in the rats at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Oral LD50 (Female Rat): >5000 mg/Kg body weight

Executive summary:

The acute oral toxicity study was performed according to the Up-and-Down Procedure (OECD 425) and OPPTS 870.1100.

A single dose of test substance was administered by oral gavage to fasted female rats at a dose level of 5000 mg/kg. The rats were dosed one at a time. All rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. The rats were necropsied to detect grossly observable evidence of organ or tissue damage.

There were no instances of mortality and no overall (test day 1-15) body weight losses. Discolored feces was noted in one animal on the day of dosing (test day 1), which resolved by test day 2.

No gross lesions were present in the rats at necropsy.

Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.