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EC number: 224-079-8 | CAS number: 4196-86-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- 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
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:
- 2 018
- 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
- 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
Constituent 1
- 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.
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