[1,1':3',1''-Terphenyl]-2'-ol, 5',5''''-(2,2,2-trifluoro-1-methylethylidene)bis-

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: study according to guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol

EC Number:

610-104-3

Cas Number:

43100-47-6

Molecular formula:

C39 H29 F3 O2

IUPAC Name:

3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol

Details on test material:

- Name of the test substance used in the study report: Ligand TFME-DPP
- Purity: 94.8 g/100 g
- Test substance No.: 08/0260-1
- Homogeneity: homogeneous by visual inspection
- Physical state: white solid
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 10 – 11 weeks
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 20 – 80%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 3 and 20 g/100 ml
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg (gavage)

DOSAGE PREPARATION:
The test-substance preparation was produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

300 mg/kg: 3 animals; 2000 mg/kg: 6 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Individual body weight determination shortly before administration (day 0), weekly thereafter and on the last day of observation.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination on the last day of the observation period after sacrificed by CO2-inhalation in a chamber with increasing concentrations over time.
- No histological examinations were performed.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Clinical observation - 2000 mg/kg test group: reduced feces was observed on study day 1 after administration - 300 mg/kg test group: impaired general state, dyspnoea, and piloerection Findings were observed from hour 2 through to hour 5 after administrat

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.