4,4'-dihydroxybenzophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1h exposure on the surface of the EpiDermTM reconstructed human epidermis and a 42h post-exposure incubation time.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-dihydroxybenzophenone

EC Number:

210-288-1

EC Name:

4,4'-dihydroxybenzophenone

Cas Number:

611-99-4

Molecular formula:

C13H10O3

IUPAC Name:

4,4'-dihydroxybenzophenone

Test material form:

solid: particulate/powder

Details on test material:

Purity >99.5%w/w

Specific details on test material used for the study:

Batch number: 20160804
Purity: 100%

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: cultured

Justification for test system used:

The reconstructed human epidermal model EpiDermTM (EPI-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Solid test item - single application of nominal 25mg on top of each tissue (tissues pre-wetted with 25μl PBS (Sterile Dulbecco’s Phosphate Buffered Saline).
Liquid reference items – single application 30 μl of neat test item, negative control PBS (Sterile Dulbecco’s Phosphate Buffered Saline) or positive control SDS 5% ((Sodium Dodecyl Sulphate).

Duration of treatment / exposure:

Exposure times of test and reference items: 60 ±1 minutes to the surface of the EpiDermTM skin models.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

97.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the skin irritation potential of DHB- 4,4'-dihydroxybenzone phenone was assessed in vitro according to OECD Test Guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method.
After a 1h exposure on the surface of the EpiDermTM reconstructed human epidermis and a 42h post-exposure incubation time, viability of the tissues was assessed and compared to the negative control.
The percentage viability obtained was 97.3% and therefore: DHB - 4,4’-dihydroxybenzone phenone was classified as Non-Irritant to human skin.