ACETIC ACID, 2-(3-CHLORO-5-CYANOPHENOXY)-, ETHYL ESTER

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9th September 2013 to 11th November 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

ethyl 2-(3-chloro-5-cyanophenoxy)acetate

EC Number:

815-596-5

Cas Number:

1613307-27-9

Molecular formula:

C11H11CINO3

IUPAC Name:

ethyl 2-(3-chloro-5-cyanophenoxy)acetate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Animals were received from Charles River, Raleigh NC and Portage MI, on 10 Sep 2013 and 17 Sep 2013. Following an acclimation period of at least five days, six healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The animals were Identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was available ad libitum.
The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.
The pretest body weight range was 200 - 230 grams. The weight variation of the animals used did not exceed ±20% of the mean body weight of the previously dosed animals.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test article was mixed with distilled water to make dosing by gavage possible. The dose was based on the dry weight of the test article. A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to six female rats.

Doses:

One dose of 2000 mg/kg test material

No. of animals per sex per dose:

Initially three healthy female Sprague Dawley rats were dosed orally with L-005183690-000F003 at 2000 mg/kg. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg.

Control animals:

no

Details on study design:

Dosing
The test article was mixed with distilled water to make dosing by gavage possible. The dose was based on the dry weight of the test article. A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to six female rats.

Type and Frequency of Observations
In Vivo - Animals were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination
Post Mortem - All animals were humanely sacrificed using CO2 and were examined for gross pathology following study termination.

Analysis of Data
The test article was assigned to a toxic category and an estimate of the LD50 was made based on the mortality results.
The test article was assigned to a toxic category according to the current Globally Harmonized System of Classification and Labeling of Chemicals (GHS). United Nations - New York and Geneva.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All six female animals survived the 2000 mg/kg oral dose.

Clinical signs:

other: There were no abnormal physical signs observed.

Gross pathology:

The gross necropsy of all animals revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

L-005183690-000F003 is considered to be in Acute Toxic Category 5, or unclassified. The oral LD50 is greater than 2000 mg/kg in female rats.

Executive summary:

Objective: To determine the potential for oral toxicity using the Acute Toxic Class Determination. This study was designed to comply with the standards set forth in the current OECD Guidelines for the Testing of Chemicals, Guideline 423. Guideline 423 is referred to in OPPTS 870.1000 as an acceptable method to assess lethality within a dose range. The test article was assigned to a toxic category based on the
mortality results and significant clinical signs of toxicity up to the Category 4 value tested according to the current Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
Method Synopsis: Initially three healthy female Sprague Dawley rats were dosed orally with L-005183690-000F003 at 2000 mg/kg. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology.
The test article was assigned to a toxic category based on the mortality response noted.
Summary:
All six female animals survived the 2000 mg/kg oral dose.
There were no abnormal physical signs observed.
All animals gained body weight by study termination; one animal lost weight between Days 7 and 14.
The gross necropsy of all animals revealed no observable abnormalities.
Conclusion: L-005183690-000F003 is considered to be in Acute Toxic Category 5, or unclassified The oral LD50 is greater than 2000 mg/kg in female rats.