Pentaerythritol tetrabenzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.02.2018 - 15-02-2018

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

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)

Test animals / tissue source

Species:

cattle

Strain:

other: Bos primigenius Taurus (fresh bovine corneas)

Details on test animals or tissues and environmental conditions:

Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 μg/mL) in a suitable cooled container within 1 hour.

Test system

Vehicle:

Hank's balanced salt solution

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

20% in Hank’s Balanced Salt Solution (HBSS) 10-fold concentrated, diluted in demin. water (1:10).

Duration of treatment / exposure:

4 h

Duration of post- treatment incubation (in vitro):

90 min

Number of animals or in vitro replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

ca. 0.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

2

Value:

ca. 1.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

3

Value:

ca. -0.25

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:

The test item Pentaerythritol tetrabenzoate was tested as a 20% suspension in HBSS. Under the conditions of this test, the test item Pentaerythritol tetrabenzoate showed no effects on the cornea of the bovine eye and can be considered not to be eye damaging. The calculated IVIS is 0.48. According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for serious eye damage (UN GHS No Category) The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria. No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

Executive summary:

This in vitro BCOP study following OECD 437 was performed to assess corneal damage potential of Pentaerythritol tetrabenzoate by quantitative measurements of changes in opacity and permeability in a bovine cornea. Two experiments were performed. The first experiment was discontinued after the second opacity measurement, because the opacity values of two replicates of the negative control were too high. Therefore the first experiment was declared invalid and was discontinued.

The results and data of the invalid experiment are not included in this final report but will be archived with the raw data in the GLP Archive of the Test Facility. The second experiment was valid and reported. The test item Pentaerythritol tetrabenzoate was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured. The test item was tested as a 20% suspension in HBSS. Under the conditions of this test, the test item Pentaerythritol tetrabenzoate showed no effects on the cornea of the bovine eye and can be considered not to be eye damaging. The calculated IVIS is 0.48. According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for serious eye damage (UN GHS No Category). The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria. No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.