N,N-dimethyl-3-(octadecyloxy)propylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25 July 2007 to 20 August 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyl-3-(octadecyloxy)propylamine

EC Number:

241-516-8

EC Name:

N,N-dimethyl-3-(octadecyloxy)propylamine

Cas Number:

17517-01-0

Molecular formula:

C23H49NO

IUPAC Name:

dimethyl[3-(octadecyloxy)propyl]amine

impurity 1

Reference substance name:

Unknown impurities

IUPAC Name:

Unknown impurities

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Females: nulliparous and non-pregnant
- Age at study initiation: 8-12 weeks
- Housing: in groups of up to four in suspended solid-floor
- Diet: free access
- Water: free access
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

EXPERIMENTAL PREPARATION
The test material was freshly prepared, as required, as a solution in arachis oil BP. It was used because the test material did not dissolve/suspend in distilled water.

PROCEDURE
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg

No. of animals per sex per dose:

five animals

Control animals:

not specified

Details on study design:

PROCEDURE
In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was treated at a dose level of 2000 mg/kg.

In the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals was treated at a dose level of 2000 mg/kg.

A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.

Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily.

Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.

At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg.

Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, diarrhoea, pilo-erection, diuresis, and red/brown staining around the ano-genital region and eyes. One animal in this dose group appeared normal throughout the observation period and the remaining animals appeared normal four, five or six days after dosing.

Body weight:

All animals showed expected gains in bodyweight

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female rat was estimated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Spraghe-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guideline 420 Fix Dose Method and Method B1 bis.

 

Following a sighting test in which there were no mortalities at dose levels of 300 and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

The acute oral median lethal dose (LD50) of the test material in the female rat was estimated to be greater than 2000 mg/kg bodyweight.