Benzoic acid, 4-nitro-, 2-ethylhexyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-Nitrobenzoic acid-2-ethylhexylester

EC Number:

605-350-3

Cas Number:

16397-70-9

Molecular formula:

C15 H21 N O4

IUPAC Name:

p-Nitrobenzoic acid-2-ethylhexylester

Details on test material:

Name of the test substance used in the study report: p-Nitrobenzoesaeure-2-ethylhexylester
Purity: 99.5% (GC)
- Physical state: LIQUID, LIGHT YELLOW
- Lot/batch No.: 22 170/85
- Stability under test conditions: WAS CONFIRMED BY ANALYSIS
- Storage condition of test material: ROOM TEMPERATURE

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were housed in stainless steel wire mesh cages with no bedding in the cages (sawdust in the waste trays). Identification of the rats via cage cards and tail marking. The animals were housed in fully air-conditioned rooms with central air-conditioning in a range of 20 - 24°C for temperature and 30 - 70% for relative humidity. The day/night rhythm was 12 h dark and 12 h light. A standardized laboratory diet was offered; drinking water (tap water) was available ad libitum.
Young adult rats of a comparable weight were used: males 190-199g; females 170-181g
ANIMAL BREEDER: DR. K. THOMAE GMBH, Germany
ACCLIMATIZATION PERIOD: AT LEAST 1 WEEK
FASTING PERIOD: ABOUT 16 HOURS BEFORE ADMINISTRATION (WATER WAS AVAILABLE AD LIBIDUM)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg

Doses:

681, 1470, 2200 mg/kg

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:
RECORDING OF SIGNS AND SYMPTOMS SEVERAL TIMES ON THE DAY OF ADMINISTRATION. AT LEAST ONCE EACH WORKDAY. CHECK FOR MORIBUND AND DEAD ANIMALS TWICE EACH WORKDAY AND ONCE ON HOLIDAYS.
Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Mortality:

Male animals: no mortalities
Female animals: 1 animal died within day1

Clinical signs:

Male animals: poor general state, dyspnoea, apathy, staggering, piloerection.
Female animals: poor general state, dyspnoea, apathy, abdominal position, paresis, piloerection.
All findings declined after day 2.

Body weight:

Male animals - before application: 199 g (low dose); 190 g (mid dose); 198 g (high dose).
Male animals - after 13 days: 303 g (low dose); 295 g (mid dose); 297 g (high dose).
Female animals - before application: 170 g (low dose); 181 g (mid dose); 178 g (high dose).
Female animals - after 13 days: 213 g (low dose); 226 g (mid dose); 220 g (high dose).

Gross pathology:

Animal that died (2200 mg/kg): general congestion; liver: gray-brown coloured.
Sacrificed animals: No pathologic findings noted.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information