Tributylethylammonium ethyl sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August to October 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 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute 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: Wistar strain, Crl:(WI) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charkes River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males 315-370 grams and females 202-233 grams).
- Housing: Individually housed in polycarbonate cages.
- Diet: Free access to pelleted rodent diet (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 (%): 50
- 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 9 August 2000 to 23 August 2000

Administration / exposure

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

VEHICLE
- 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.

Dose volume: 10 mL/kg body weight.

DOSAGE PREPARATION
To facilitate preparation, the test substance and test substance formulation (w/w) were heated up to 70°C within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle. The temperature of the formulation at time of dosing was 30-40°C.

One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.

The formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The formulation was held in contact with the skin with a dressing. A piece of Micropore tape was additionally used for fixation of the bandage in females only.

Frequency: Single dosage, on Day 1.

Washing: tap water.

Duration of exposure:

24 hours.

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:
- 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 end of the observation period. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none.

Statistics:

None.

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: Chromodacryorrhoea was noted in two males and one female on days 1 and/or 2. Focal erythema was seen in the treated skin-aera of two males and two females during the observation period.

Gross pathology:

No abnormalities were found at macroscopic post mortem examinations of animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

Assessment of acute dermal toxicity with TBEAES in the rat was performed according to OECD/ EC guidelines and according to GLP principles. TBEAES was administired to five Wistar rats of each sex by dermal application at 2000 mg/kg bw for 24 hours. No mortality occured. Chromodacryorrhoea was noted in two males and one female on days 1 and/or 2. Focal erythema was seen in the treated skin-area of two males and two females during the observation period. The changes noted in body weight gain in males and females were considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals.The dermal LD50 value of TBEAES in Wistar rats was established to exceed 2000 mg/kg bw. Based on these results, TBEAES does not have to be classified and has no obligatory labelling requirement for dermal toxicity according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC).