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:

From February 06, 2014 to May 15, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

yes

Remarks:

see 'Any other information on materials and methods'

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

yes

Remarks:

see 'Any other information on materials and methods'

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

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

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

Specific details on test material used for the study:

Batch No.: 5307; Purity: 99.9%

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 furnished with wood flakes
- Diet: ad libitum (2014C Teklad Global Rodent)
- Water: ad libitum
- Acclimatation period: at least 5 d
ENVIRONMENTAL CONDITIONS

- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark

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

- Preparation: the test substance was formulated within two hours of beeing applied to the test system. It is auumed that the formulation was stable for this duration
- Rationale for the selection of the starting dose: In absence of data regarding the toxicity of the test substance, 300 mg/kg was chosen as the starting dose
- Analysis: No analysis was conducted to determine homogeneity, concentration or stability of the test substance formulation

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: after 1/2 h, 1 h, 2 h and 4 h after adminstration and once daily afterwards
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - recorded prior to dosing and seven ad fourteen days after treatment

A group of three fasted females was treated with the test substance at a dose level of 300 mg/kg bw. Based on the results from this dose level, further groups of fasted females were treated at dose level of 2000 mg/kg bw. Dosing was performed sequntially. The test substance was administrated orally as a solution in dimethyl sulphxide. All animals were dosed once only by gavage, using a metal canulla attached to a graduated syringe. Clinical signs and body weight development were monitored during the study. All animals were subject of the gross necropsy.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

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

Gross pathology:

No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the study conditions, the LD50 of the test substance in female Wistar rats was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance PBBA to Wistar rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP. A group of three fasted females was treated with the test substance at a dose level of 300 mg/kg bw. Based on the results from this dose level, further groups of fasted females were treated at a dose level of 2000 mg/kg bw. Dosing was performed sequentially. The test substance 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. There was no mortality. There were no signs of systemic toxicity at any of the doses. No abnormalities were noted at necropsy. Under the study conditions, the LD50 of the test substance in female Wistar rats was determined to be >2000 mg/kg bw (Pooles, 2014).