Benzoic acid, 2-([1,1'-biphenyl]-4-ylcarbonyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 6 - May 15 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD Guideline and EU Method on testing and assessment in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

same as guideline

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

2-(4Phenylbenzoyl)benzoic acid

IUPAC Name:

2-(4Phenylbenzoyl)benzoic acid

Constituent 2

Reference substance name:

2-{[1,1'-biphenyl]-4-carbonyl}benzoic acid

EC Number:

700-862-4

Cas Number:

42797-18-2

Molecular formula:

C20 H14 O3

IUPAC Name:

2-{[1,1'-biphenyl]-4-carbonyl}benzoic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): 2-(4Phenylbenzoyl)benzoic acid
- Physical state: white powder
- Analytical purity: 99.9%
- Lot/batch No.: 5307
- Expiration date of the lot/batch: 01 May 2015
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK, Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 161 - 180 g
- Fasting period before study: overnight
- Housing: in groups in suspended solid floor polypropylene cages
- Diet: ad libitum (2014C Teklad Global Rodent)
- Water: ad libitum
- Acclimatation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours cycle

IN-LIFE DATES: From: April 1 2014 To: April 29 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 - 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: the substance was not soluble in water or arachis oil BP
-
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In absence of data regarding the toxicity of the test item, 300mg/kg was chosen as the starting dose.

Doses:

300 - 2000 - 2000mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: after 1/2 hour, 1 hour, 2 hours, 4 hours after adminstration and once daily afterwards
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Clinical signs:

other: hunched posture observed for all animals

Gross pathology:

No abnormalities were noted

Any other information on results incl. tables

see attached document with all tables.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category V

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500mg/kg body weight.

Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Methods

A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at a dose level of 2000 mg/kg body weight. Dosing was performed sequentially. The test item was administered orally as a solution in dimethyl sulphoxide. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality.

There were no deaths.

Clinical Observations.

Hunched posture was noted in all animals treated at a dose level of 300 mg/kg and three animals treated at a dose level of 2000 mg/kg. Ataxia and/or pilo-erection were also noted in three animals treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity noted in three animals treated at a dose level of 2000 mg/kg.

Body Weight.

All animals showed expected gains in body weight.

Necropsy.

No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight (Globally Harmonized Classification System - Category 5, >2000 - 5000 mg/kg body weight).