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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay

Test type:

standard acute method

Limit test:

yes

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 test material (as cited in study report): Ligand TFME-DPP
- Physical state: solid/white
- Analytical purity: 97.5% (HPLC, 236 nm) and 97.2% (HPLC, 300 nm)
- Batch No.: 01829-00216
- Expiration date of the lot/batch: June 2016
- 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:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: males approx. 8 weeks, females approx. 12 weeks
- Weight at study initiation: males 227.2g, females 204.2 g
- Housing: single
- Diet: VRF1(P) diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: at least 10
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: at removal of the dressing (24h after application)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (4.44 ml/kg bw)
- Concentration (if solution): 45g/100ml

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

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: individual body weights were determined shortly after application, weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, assessment of skin reactions

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

No macroscopic pathologic abnormalities