1-Hexanaminium, 6-bromo-N,N,N-trimethyl-, bromide (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP. Only a range finding study with few animals was performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Few animals were used.

GLP compliance:

yes (incl. QA statement)

Test type:

other: range-finding study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(6-Bromohexyl)trimethylammonium bromide

IUPAC Name:

(6-Bromohexyl)trimethylammonium bromide

Test material form:

other: solid

Details on test material:

Name: (6-Bromohexyl)trimethylammonium bromide:
Batch No.: NEU 2592
Appearance: white solid
Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Three male and three female Sprague-Dawley CD strain rats supplied by Charles River (UK) Ltd., were used. At the start of the study the males weighed 150 to 160g, and the females 140 to 146g, and were five to eight weeks of age.
After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on-a cage card.
The animals were housed in groups of up to three by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 19 to 21 °C and relative humidity of 50 to 56%. The rate of air exchange was approximately fifteen changes per hour and the fighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The animals were fasted overnight before dosing.
Dose volume: 10 mL/kg bw.

Doses:

25 - 200 - 2000 mg/kg bw

No. of animals per sex per dose:

1 m + 1 f.

Control animals:

no

Details on study design:

The test material was freshly prepared, as required, as a solution at the appropriate concentration in distilled water.

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One high dosed male died within 30 min p.a.

Clinical signs:

other: Clinical signs of toxicity noted in animals treated with 2000 or 200 mg/kg were hunched posture, lethargy and decreased respiratory rate. No clinical signs of toxicity were noted in animals treated with 25 mg/kg.

Gross pathology:

Abnormalities noted at necropsy of the male treated with 2000 mg/kg which was found dead 30 minutes after dosing were haemorrhagic lungs, dark liver and dark kidneys.
No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LDS0) of the test material, (6-Bromohexyl) trimethylammonium bromide, in the Sprague-Dawley CD strain rat was found to be approximately 2000 mg/kg bodyweight.

Executive summary:

A range finding study was performed. The acute oral median lethal dose (LDS0) of the test material, (6-Bromohexyl) trimethylammonium bromide, in the Sprague-Dawley CD strain rat was found to be approximately 2000 mg/kg bodyweight.