9-Octadecenoic acid (Z)-, sulfonated, potassium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 03, 1985 to December 17, 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, sulfonated, potassium salts

EC Number:

271-843-1

EC Name:

9-Octadecenoic acid (Z)-, sulfonated, potassium salts

Cas Number:

68609-93-8

Molecular formula:

A generic formula cannot be provided for this UVCB substance. The alkyl chain length of the sulfonated fatty acids range from C12-C22, however the major alkyl chain is C18.

IUPAC Name:

9-Octadecenoic acid (Z)-, sulfonated, potassium salts

Test material form:

other: liquid

Details on test material:

-- Name of test material (as cited in study report) and in the signed statement on substance identity provided by the data holder: Lankropol OPA
- Physical state: Dark amber liquid containing 55% oleic acid, sulfonated, potassium salts and 45% water
- Received: November 15 1985
-- Storage: Ambient temperature
- Stability and absorption: Not determined

Test animals

Species:

rat

Strain:

other: Sprague-Dawley derived strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charres River U.K. Limited, Margate, Kent, England
- Age at study initiation: Four to six weeks
- Weight at study initiation: 105 to 140 g
- Fasting period: Access to food only was prevented overnight prior to and approximately 4 h after dosing
- Housing: Metal cages with wire mesh floors
- Diet: Standard laboratory rodent diet (i.e., Labsure LAD 1) ad libitum
- Water: ad libitum
- Acclimation period: minimum period of 6 d
- Identification: Each animal was identified by cage number and ear punching

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C and 22°C minimum and maximum temperatures respectively
- Humidity (%): 63%
- Air changes (per hr): 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 4.4 mL/kg
5.0 g/kg bw based on a specific gravity of 1.125

Doses:

5.0 g/kg bw, equivalent to 2,723 mg/kg bw active ingredient

No. of animals per sex per dose:

Five/sex/dose (main study)
Two/sex/dose (preliminary study)

Control animals:

not specified

Details on study design:

Preliminary study
A trial test was carried out by dosing two male and two female rats at 2,723 mg/kg bw active ingredient.

Main study
A group of ten rats (i.e., five males and five females) was treated at 5.0 g/kg bw

Treatment procedure
The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter.

Observation period
5 and 14 d for preliminary and main studies respectively

Observation
Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation.

The following were recorded on the main study:

-The nature, severity, approximate time of onset and duration of each toxic sign.
-Individual bodyweights of rats on Days 1 (day of dosing), 8 and 15.

-All animals on the main study were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 723 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths occurred during the whole study

Clinical signs:

other: Signs of reaction to treatment observed shortly after dosing in all rats were pilo-erection, abnormal body carriage (i.e., hunched posture), abnormal gait (i.e., waddling) and diarrhea. Recovery as judged by external appearance and behaviour was apparent

Gross pathology:

Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Under the study conditions, the oral LD50 was found to be >2,723 mg/kg bw active ingredient in rats.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in CD rats of the Sprague-Dawley derived strain according to OECD Guideline 401. Group of five female and three male fasted rats received a single oral (gavage) dose of 2,723 mg/kg bw active ingredient. Undiluted test substance was administered at a volume of 4.4 mL/kg bw. No mortality occurred and no significant macroscopic abnormalities were seen at necropsy. However, clinical signs were observed (pilo-erection, hunched posture, waddling and diarrhea) in all rats for up to 3 days after treatment. Under the study conditions, the oral LD50 was found to be >2,723 mg/kg bw active ingredient in rats (Kynoch, 1986).