Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-01-29 until 2003-02-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-860-6

EC Name:

-

Cas Number:

302776-68-7

Molecular formula:

C24 H31 N O4

IUPAC Name:

hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld; Germany
- Age at study initiation: Young adult animals - approx. 14- 18 weeks
- Weight at study initiation: 195 g mean weight in the first experiment and 201g in the following experiment
- Fasting: Feed was withdrawn from the animals at least 16 hours before administration of the test substance.
- Housing: Single housing in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation for at least 5 days

ENVIRONMENTAL CONDITIONS
-The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range of 20 - 24°C and of 30- 70% relative humidity.
- Photoperiod (hrs dark / hrs light): 12 h /12 h

IN-LIFE DATES: From: 2003-01-30 (first administration) To: 2003-02-19

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE- Olive oil Ph.Eur./DAB
- Concentration in vehicle: 40 g test substance / 100 mL
- Amount of vehicle: 5 mL/kg
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION:
The test substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer. For a better handling the test substance was melted at about 60°C. The preparation was cooled down to body temperature.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The selection of dose was based on the physical and chemical characteristics of the test substance and its composition. As no pronounced acute oral toxicity was expected, a starting dose of 2,000 mg/kg body weight has been chosen to be given to 3 animals of a single sex per step (as instructed by the OECD 423 guideline for a acute toxic class method).
Regarding the use of the class method in the study: As none of those animals died, 2,000 mg/kg body weight were administered to another group of 3 female animals in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

In total: 6 female animals at 2000 mg/kg.
3 female animals in the first step (first experiment)
3 female animals in the second step (second experiment)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms were done at least once a day. Individual body weights was measured shortly before administration (day 0), after one week and at the end of the study. A check for any dead or moribund animal was made twice a day.
- Necropsy with gross-pathology examination was done on the last day of the observation period after killing the animals with CO2.

Statistics:

Not indicated (regarding body weight)

Results and discussion

Preliminary study:

There was no need of a preliminary study. The study was performed according to the Acute Toxic Class method

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical observations were noticed during the clinical examinations.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the 6 examined animals.

Other findings:

No other findings.

Any other information on results incl. tables

No remarks.