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EC number: 224-079-8 | CAS number: 4196-86-5
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
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%). Pentaerythritol tetrabenzoate is considered non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method.
An in vitro study following OECD 439 was performed in order to evaluate the potential of Pentaerythritol tetrabenzoate to evoke skin irritation in a reconstructed human epidermis (RhE) test method.
The test item Pentaerythritol tetrabenzoate is considered as non-irritant to skin. After the treatment, the mean value of relative tissue viability was reduced to 96.9%. This value is above the threshold for skin irritation (50%) according to OECD 439. The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
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.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 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
- 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. - 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.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.02.2018 - 23.02.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 system:
- human skin model
- Remarks:
- 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.
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia.
- Vehicle:
- other: The tissues were wetted with 25 μL DPBS buffer before applying the test item and spreading it to match the tissue size.
- Details on test system:
- DPBS-buffer: Solution for the rinsing of the tissues and solvent for MTT concentrate, also used as negative control. A subset was procured by MatTek In Vitro Life Science Laboratories; the other subset was prepared by LAUS GmbH.
Composition of the subset from MatTek In Vitro Life Science Laboratories (batch no.: 092817MGKA):
KCl 0.2 g
KH2PO4 0.2 g
NaCl 8.0 g
Na2HPO4 * 7H2O 2.16 g
H2O ad 1 L
Composition of the subset from LAUS GmbH (batch no.: 20171114):
KCl 0.2 g
KH2PO4 0.2 g
NaCl 8.0 g
Na2HPO4 * 2H2O 1.44 g
H2O ad 1 L - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Tissue 1: 25.5 mg
Tissue 2: 26.0 mg
Tissue 3: 25.3 mg - Duration of treatment / exposure:
- Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were transferred into the incubator for 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2. hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
- Duration of post-treatment incubation (if applicable):
- After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL). Then, the tissues were set in the incubator for 23 hours and 25 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1
- Value:
- ca. 96.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2
- Value:
- ca. 97
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 3
- Value:
- ca. 97.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Pentaerythritol tetrabenzoate is considered as non-irritant to skin. After the treatment, the mean value of relative tissue viability was reduced to 96.9%. This value is above the threshold for skin irritation (50%) according to OECD 439. The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%). For these reasons, the result of the test is considered valid. - Executive summary:
This in vitro study following OECD 439 was performed in order to evaluate the potential of Pentaerythritol tetrabenzoate to evoke skin irritation in a reconstructed human epidermis (RhE) test method.
The test item Pentaerythritol tetrabenzoate is considered as non-irritant to skin. After the treatment, the mean value of relative tissue viability was reduced to 96.9%. This value is above the threshold for skin irritation (50%) according to OECD 439. The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.
Referenceopen allclose all
The mean value of relative tissue viability of the test item was reduced to 96.9% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.
All validity criteria were met. Values for negative control and for positive control were within the range of historical data
of the test facility.
Eye irritation
Link to relevant study records
- 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
- 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
- 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)
- 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) - 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.
- 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
- 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
- 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
- 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
- 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.
Reference
Additional information
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