Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14-28 November 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

purity of test item, environmental conditions not reported

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

purity of test item, environmental conditions not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides

EC Number:

948-061-0

Molecular formula:

C18 H40 NO+ Cl- ; C20 H44 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H48 NO+ Cl-

IUPAC Name:

Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Chimex / M 303- Physical state: Yellowish limpid liquid- Date received: October 9, 1995- Purity test date: July 27, 1995STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Stored at room temperature, away from the light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

OFA

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: IFFA-CREDO (69210 - L'ARBRESLE, FRANCE).- Age at study initiation: 6 weeks- Weight at study initiation: 190-206 g (males); 162-178 g (females)- Fasting period before study: Animals have been fasted prior to test substance administration by withholding food overnight.- Housing: 5 animals by sex in polypropylene cages (310 x 465 x 190)- Diet: Complete pelleted rat maintenance diet UAR A04-10 (91360 - EPINAY SUR ORGE, FRANCE), ad libitum- Acclimation period: 5 days IN-LIFE DATES: 14-28 November 1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

VEHICLE - Concentration in vehicle: 400 mg/L MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw DOSAGE PREPARATION Test substance was diluted in distilled water and the preparation was kept under magnet stirring during the treatments.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: The animals were observed daily for 14 days after the treatment. A clinical observation was carried out at least once a day in order to evaluate the general appearance, the behaviour and vegetative functions of the animals. An individual clinical observation was realized one hour after treatment. The continuous observations during the five following hours were renewed each following day. Body weight was taken just prior to the test substance administration (Day 1) and on Days 3, 7 and 14 after the treatment. - Necropsy of survivors performed: Yes; all the animals dead during the test were autopsied. On Day 14, the rats were sacrificed after lethal barbituric anaesthesia, then autopsied. All abnormalities were recorded. No tissues are saved

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was observed in 40 % females and no mortality was observed in males.

Clinical signs:

- One hour after treatment slight piloerection was noticed in all animals, lasting for the 5 following hours.- 24 hours after treatment all animals show toxic signs: important piloerection, diarrhea, hollow flanks, noisy breathing, porphyrin around the eyes. The next morning (Day 3) one female animal was found dead, another lost weight, this latter was found dead 24 hours later. On Day 4 all other surviving animals were appeared to be normal, until the end of the study.

Body weight:

The individual growth weight of all surviving animals (males and females) was normal and regular. All animals showed expected gains in body weight over the 14 day study period.

Gross pathology:

The post mortem examination of 2 female animals died during the test revealed lesions at stomach level (very distended wall, presence of coagulated blood).No macroscopic abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the LD50 of test substance is higher than 2000 mg/kg bw and not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, Sprague-Dawley OFA rats (5/sex/dose) were administered a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

Mortality was observed in 40 % females and no mortality was observed in males. Toxic signs were observed in all animals between the 6th and 24th hours after treatment: piloerection, diarrhea, noisy breathing and hollow flank. All animals showed expected gains in body weight over the 14 day study period. No macroscopic abnormalities were noted at necropsy. Some stomach lesions (distension and haemorrhage) were noticed in animals died during the study.

 

Rat Oral LD50 (combined) > 2000 mg/kg bw

Under the experimental conditions of this study, the LD50 of test substance is higher than 2000 mg/kg bw and not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.