1-(2,4,6-trichlorophenyl)acetone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-10-22 until 2013-11-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was carried out following OECD guideline 425 and in compliance with GLP. The method description is well documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(2,4,6-trichlorophenyl)acetone

EC Number:

810-702-6

Cas Number:

1228284-86-3

Molecular formula:

C9H7Cl3O

IUPAC Name:

1-(2,4,6-trichlorophenyl)acetone

Test material form:

solid: crystalline

Details on test material:

- Physical state: Yellowish crystals
- Purity test date: 19 September 2013
- Expiration date of the lot/batch: End September 2015
- Stability under test conditions: Stable until end September 2015
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S.Pietro al Natisone (UD), Zona Industriale Azzida, 57, 33040, Italy
- Strain: RccHan:WIST
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 184-193 g
- Fasting period before study: Yes (overnight)
- Housing: Individually in Type II. polypropylene/polycarbonate cages
- Diet: Ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" ad libitum (except for overnight pre-dose fast and for 3 hours post dose) - Ssniff Spezialdiäten GmbH, D-59494 Soest Germany
- Water: Municipal tap water ad libitum
- Acclimation period: At least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 October 2013 To: 14 November 2013

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% CMC in distilled water

Details on oral exposure:

DOSE VOLUME: 10 mL/kg body weight

Doses:

2000 and 550 mg/kg bw

No. of animals per sex per dose:

1 female at 550 mg/kg bw, 3 females at 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed individually after dosing at 30 minutes, 1, 2, 3, 4, and 6 hours and once each day for 14 days thereafter. Body weights were recorded on Days -1 (prior to the removal of food), 0 (prior to administration), 7 and 14.
- Necropsy of survivors performed: Yes

Statistics:

Data was evaluated using the Acute Oral Toxicity (OECD Test Guidelines 425) Statistical Programme (AOT 425 Stat Pgm).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities

Clinical signs:

There were no treatment-related clinical signs.

Body weight:

There were no treatment related body weight changes.

Gross pathology:

There was no treatment related macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the acute oral median lethal dose LD50 of the test item was greater than 2000 mg/kg bw in RccHan:WIST female rats.

Executive summary:

An acute oral toxicity (up and down procedure) study was conducted with 4 animals (female RccHan:WIST rats). Animals were treated with a single oral (gavage) dose of the test item at a dose level of 550 (1 animal) or 2000 (3 animals) mg/kg body weight (bw) followed by a 14 day observation period. The animals were fasted overnight prior to treatment and food was returned 3 hours after dosing. All animals were observed individually after dosing at 30 minutes, 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured on Day -1 (prior to removal of food), Day 0 (prior to administration) and weekly thereafter. All animals were examined macroscopically at the end of the study.

No deaths occurred during the study. Treatment with at 550 or 2000 mg/kg bw did not cause any test item related adverse effects during the 14 days observation period. There was no evidence of the macroscopic observations in animals terminated on Day 14. There were no treatment related changes in the body weights. The body weights of the animals were within the range commonly recorded for this strain and age.

Under the conditions of this study, the acute oral median lethal dose LD50 of the test item was greater than 2000 mg/kg bw in RccHan:WIST female rats.