[1,1'-Biphenyl]-2,2'-diol, 3,3'-bis(1,1-dimethylethyl)-5,5'-dimethoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidlines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The EPISKIN model

Deviations:

no

Principles of method if other than guideline:

The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKIN TM reconstituted human epidermis model after a treatment period of 15 min. followed by a post-exposure incubation period of 42 h. The principle of the assay is based on the measurement of cytotoxicity in recostituted human epidermal cultures following topical exposure to the test material by means of colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue frozen salt (with the mitochondria of viable cells) in the test material treated tissues relative to the negativ controls. The concentration of the inflammatory mediator IL-1a in the culture medium retained following the 42 hour post exposure incubation period is also determined for test materials which are found to be borderline non irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the non-irritant result.
The EPISKIN model is a three dimensional reconstituted human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of collagene type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after 13 day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

6,6'-di-tert-butyl-4,4'-dimethoxy-[1,1'-biphenyl]-2,2'-diol

EC Number:

604-200-4

Cas Number:

14078-41-2

Molecular formula:

C22 H30 O4

IUPAC Name:

6,6'-di-tert-butyl-4,4'-dimethoxy-[1,1'-biphenyl]-2,2'-diol

Test animals

Species:

other: EPISKIN TM human epidermis model

Strain:

other: EPISKIN TM human epidermis model

Details on test animals or test system and environmental conditions:

Not applicable. No animals used in this study.

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

10 +/- 2 mg

Duration of treatment / exposure:

15 min.

Observation period:

approx. 42 h

Number of animals:

not applicable

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: MTT uptake

Value:

0

Remarks on result:

other:

Remarks:

Basis: other: visual evaluation -EPISKIN TM Model Kit. Time point: 15 min. Max. score: 0.0. Reversibility: no data. Remarks: = blue tissue (viable). (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: OD540 values

Value:

0

Remarks on result:

other:

Remarks:

Basis: other: EPISKIN TM model kit. Time point: 15. Max. score: 0.0. Reversibility: no data. Remarks: The relative mean viability of the test material tissues was 103,3% after 15 minutes exposure.. (migrated information)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test material was considered to be non-irritant.