Tributylethylammonium ethyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1999 - January 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tributylethylammonium ethyl sulphate

EC Number:

268-329-4

EC Name:

Tributylethylammonium ethyl sulphate

Cas Number:

68052-51-7

Molecular formula:

C14H32N . C2H5O4S (or C16H37NO4S)

IUPAC Name:

tributyl(ethyl)azanium ethyl sulfate

Details on test material:

- Name of test material (as cited in study report): TBEAES
- Substance type: organic
- Physical state: Paste
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

other: Crl:(WI) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 7 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males 260 - 277 grams, females 172-188 grams).
- Fasting period before study: Food was witheld overnight (for maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labeled polycarbonate cages containing purified sawdust as bedding material.
- Diet: Free access to pelleted rodent diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 21
- Humidity (%): 30 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12

Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.

IN-LIFE DATES: From: 28 December 1999 tot 13 January 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

GAVAGE METHOD: stainless steel stomach tubes.

Frequency: single dosage, on Day 1.

- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 mL/kg) body weight.

DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. The test substance was heated up to 70°C immediately prior to formulation. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females and 3 males in a stepwise manner

Control animals:

no

Details on study design:

Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period. Descriptions of all internal macroscopic abnormalities were recorded
- Other examinations performed: none.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

other: In one female, uncoordinated movements were noted on day 1. No clinical signs were noted in the remaining two females. Among males, tremors and/or uncoordinated movements were noted on day 1.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 >2000 mg/kg bw was determined.

Executive summary:

Assessment of acute oral toxicity of TBEAES was performed in Wistar rats according to OECD/EC guidelines and GLP principles. TBEAES was administired in a single dose to rats of both sexes at 2000 mg/kg body weight. No mortality occured. In one female, uncoordinated movements were noted on day 1. No clinical signs were noted in the remaining two females. Among males, tremors and/or uncoordinated movements were noted on day 1. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. the oral LD50 value of TBEAES in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results TBEAES does not have to be classified and has no obligatory labelling requirements for oral toxicity according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC).