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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP, test method is under validation

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:

other: OECD (2014a) Draft Proposal for a New Test Guideline: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

The study method is based on the assumption that chemicals inducing serious eye damage or eye irritation will induce cytotoxicity in the corneal epithelium. 3D models of human corneal epithelium are treated with test substance, followed by a recovery period and measurement of tissue viability. Relative viability (test substance vs. negative control) is used to predict whether a substance requires classification or not.
Study guideline is available at: http://www.oecd.org/chemicalsafety/testing/RhCE-Test-Method-for-Identifying-Chemicals-Not-Requiring%20Classification-Labelling-for-Eye-Irritation-Draft-New-TG-2014-07-25.pdf

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab

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

Test material form:

other: solid, white

Details on test material:

- Name of test material (as cited in study report): Ligand TFME-DPP
- Physical state: solid, white
- Test substance No.: 08/0260-2
- Batch No.: 01829-00216
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:

other: not applicable (in vitro)

Strain:

other: not applicable (in vitro)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

- treated tissues: bulk volume of 50 µl of test material (about 16 mg)
- negative control: 50 µl sterile de-ionized water
- positive control: 50 µl methyl acetate (98+%)

Duration of treatment / exposure:

After application of test substances or controls, the tissues were incubated for 6 hours at 37°C. They were subsequently washed with sterile PBS and immersed in pre-warmed medium to remove residual chemical.

Observation period (in vivo):

After washing, the tissues were returned into the incubator for 18 hours prior to MTT testing.

Number of animals or in vitro replicates:

not applicable (in vitro)

Results and discussion

Any other information on results incl. tables

Due to the ability of the test substance to directly reduce MTT in pre-tests, killed controls were applied in parallel. However, the result of the killed control did not indicate an increased MTT reduction, thus it was not used for viability calculation.

The data obtained is conformant with the above-mentioned acceptance criteria.

Findings:

		tissue 1	tissue 2	mean KC	mean	inter-tissue variability (%)
NC	mean OD(570)	1.775	1.652	0.043	1.714
	viability (% of NC)	103.6	96.4		100	7.2
08/0260-2	mean OD(570)	1.832	1.753	0.034	1.793
	viability (% of NC)	106 .9	102.3		105	4.6
PC	mean OD(570)	0.398	0.363		0.381
	viability (% of NC)	23.2	21.2		22	2.0