Pentaerythritol tetrabenzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.02.2018 - 22.02.2018

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: Human Skin Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol tetrabenzoate

EC Number:

224-079-8

EC Name:

Pentaerythritol tetrabenzoate

Cas Number:

4196-86-5

Molecular formula:

C33H28O8

IUPAC Name:

3-(benzoyloxy)-2,2-bis[(benzoyloxy)methyl]propyl benzoate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Name: Pentaerythritol tetrabenzoate
Appearance: off-white solid
Composition: Pentaerythritol tetrabenzoate >96%
CAS No.: 4196-86-5
EINECS-No.: 224-079-8
Molecular formula: C33H28O8
Molecular weight: 552.576 g/mol
Purity: >96%
Homogeneity: homogeneous
Expiry date: Nov. 2018
Storage: Room Temperature (20 ± 5°C)

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: See details on test system

Cell source:

other: See details on test system

Source strain:

other: See details on test system

Details on animal used as source of test system:

n.a.

Vehicle:

water

Details on test system:

The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized 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. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.

EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia.
Designation of the kit: EPI-200-SCT
Day of delivery: 20. Feb. 2018
Batch: 25882

Control samples:

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

Tissue 1: 26.5 mg (3 minutes), 25.9 mg (1 hour)
Tissue 2: 26.4 mg (3 minutes), 25.6 mg (1 hour)

Duration of treatment / exposure:

3 min and 1 hour

Duration of post-treatment incubation (if applicable):

3 hours

Number of replicates:

3 replicates per group

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

>= 94.4 - <= 102.3

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Other effects / acceptance of results:

The mean value of relative tissue viability of the test item was increased to 102.3% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1 hour treatment, the mean value of relative tissue viability of the test item was reduced to 94.4%, lying above the threshold for corrosivity (15%). Therefore, the test item is considered as non-corrosive to skin.

The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.8 (3 minutes) resp. 1.9 (1 hour). The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 6.6% Values for negative control and for positive control were within the range of historical data of the test facility. Therefore the experiment is considered valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Pentaerythritol tetrabenzoate is considered non-corrosive to skin. After 3 minutes treatment, the mean value of relative tissue viability of the test item was increased to 102.3%. This value is well above the threshold for corrosivity according to OECD TG 431 (50%). After 1 hour treatment the mean value of relative tissue viability of the test item was reduced to 94.4%. This value is well above the threshold for corrosivity (15%) according to OECD TG 431.

Executive summary:

A skin corrosion study in the Reconstructed Human Epidermis (RHE) Test Method following OECD Guideline 431 was conducted in order to determine the skin corrosive properties of Pentaerythritol tetrabenzoate.

After 3 minutes treatment with the test item, the mean value of relative tissue viability was increased to 102.3%. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, the mean value of relative tissue viability was reduced to 94.4%. This value is also above the threshold for corrosion potential (15%).

Values for negative control and for positive control were within the range of historical data of the test facility confirming the validity of the experiment.

Pentaerythritol tetrabenzoate is considered non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method.