4,4'-bis(diethylamino)benzophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 February 2018 - 23 February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

adopted 29 July 2016

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-bis(diethylamino)benzophenone

EC Number:

202-025-4

EC Name:

4,4'-bis(diethylamino)benzophenone

Cas Number:

90-93-7

Molecular formula:

C21H28N2O

IUPAC Name:

4-[4-(diethylamino)benzoyl]-N,N-diethylaniline

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 171116
- Expiration date of the lot/batch: 16 November 2019

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Recommended test system in international guidelines (OECD and EC).

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg

Duration of treatment / exposure:

3-minutes and 1-hour

Number of replicates:

Total of 4 tissues

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3-minutes

Value:

101

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1-hour

Value:

97

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The substance was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the substance to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the substance did not interfere with the MTT endpoint.

The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit less than 2.8) and the laboratory historical control data range. The mean relative tissue viability following the 1-hour exposure to the positive control was 6.0%.

Any other information on results incl. tables

Mean Tissue Viability in the in vitro Skin Corrosion Test

	3-minute application viability (% of control)	1-hour application viability (% of control)
Negative control	100	100
Positive control	7.5	6.0
Substance	101	97

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the substance is not corrosive in the in vitro skin corrosion test.

Executive summary:

The substance was evaluated for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). Human skin tissue (eipdermis keratinocytes) was exposed to the undiluted substance for 3-minutes or 1-hour according to the procedures described in the most recent OECD and EC guidelines. Skin corrosion is expressed as the remaining cell viability after exposure to the substance. The relative mean tissue viability obtained after 3-minute and 1-hour exposure with the substance compared to the negative control tissues was 101% and 97%, respectively. Resultantly, the substance is considered to be non-corrosive to skin.