Acetamide, N-(4-fluorophenyl)-2-hydroxy-N-(1-methylethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - April 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

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:

N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide

EC Number:

611-084-9

Cas Number:

54041-17-7

Molecular formula:

C11H14FN

IUPAC Name:

N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide

Specific details on test material used for the study:

Purity: 99.2 %
Stability in formulation not tested

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

with 2% Cremophor EL (v/v)

Doses:

male: 1000, 800 and 500 mg/kg bw
female: 500, 400 and 200 mg/kg bw

No. of animals per sex per dose:

5 anmials per sex and dose

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

726 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

474 mg/kg bw

Based on:

test mat.

Mortality:

male: 1000 mg/kg group: 4 animals died, 800 mg/kg group: 3 animals died, 500 mg/kg group: no animal died
female: 500 mg/kg group: 3 animals died, 400 mg/kg group: 1 animal died, 200 mg/kg group: no animal died

Clinical signs:

other: The following signs were observed in males at 500 mg/kg body weight and in females at 200 mg/kg body weight: piloerection, reduced or increased activity, dyspnea, spasmodic state, lateral recumbency, and spastic or staggering gait. In the males, letharg

Gross pathology:

Animals that died during the recovery period:
In a few cases, lungs pale, distended; in a few cases, liver dark, pale, mottled, lobular pattern; kidneys pale and mottled; spleen somewhat pale; in one animal, ulcer-like foci in the glandular stomach; in one animal, stomach with clear fluid or yellowish fluid content; in one animal, small intestine slightly reddened, empty; in a few cases, intestinal tract empty, reddened; mesenteric vessels severely injected; in a few cases, abdominal organs not assessable.


Animals sacrificed while moribund:
One animal: liver pale, mottled, lobular pattern; stomach with brown fluid content; glandular stomach reddened; intestinal tract reddened, partially empty.


Animals sacrificed at the end of the recovery period:
For males, no evidence of test substance-related, gross organ damage.
For females, at 500 mg/kg body weight: in a few cases, lungs slightly distended; liver with slight lobular pattern (one animal).

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The substance is harmful if swallowed.

Executive summary:

Tests were performed to determine the acute oral toxicity to male and female rats. The study was performed in accordance with the OECD Guideline for Testing of Chemicals; Section 4: Health Effects, No. 401 - "Acute Oral Toxicity," adopted February 24, 1987 (1) and in accordance with the Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Series 81-1 Acute Oral Toxicity Study (Revised Edition, November 1984) (2).

LD50: Rat male: 726 mg/kg body weight (approximate)

LD50: Rat female: 474 mg/kg body weight (approximate).

Some of the signs that were observed occurred immediately after administration and continued until day 5 maximum. Essentially, the following signs were observed: impaired activity and dyspnea, lethargy, piloerection, spastic or staggering gait, lateral recumbency, increased salivation, atony, convulsions, spasmodic state, no reflexes. Mortalities occurred starting at a dose of 400 mg/kg body weight. The test substance is moderately toxic to rats following acute oral administration.