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EC number: 276-940-2 | CAS number: 72846-00-5
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-03-02 - 2018-03-14
- 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 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-benzyl-5-phenylbarbituric acid
- EC Number:
- 276-940-2
- EC Name:
- 1-benzyl-5-phenylbarbituric acid
- Cas Number:
- 72846-00-5
- Molecular formula:
- C17H14N2O3
- IUPAC Name:
- 1-benzyl-5-phenylpyrimidine-2,4,6(1H,3H,5H)-trione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Molecular Formula:
C17H14N2O3
Molecular Weight:
294.31
Physical Appearance:
White powder
CAS No.:
72846-00-5
Batch Number:
170240
Purity:
99.5%
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- Wistar
- Details on animal used as source of test system:
- Species:
Rat (Rattus norvegicus)
Strain:
Wistar
Justification of selection:
Rat is the rodent species and Wistar is the strain recommended by the test guideline.
Source:
Bred and reared at INTOX PVT. LTD.
Age at start of study:
22 days
No. of animals and sex:
5 males
Environmental conditions:
The experimental animal room was supplied with fresh and filtered air, with 10 to 15 air changes per hour. The room was air conditioned with temperature between 19 to 25 oC, relative humidity 30 to 70% and illumination cycle set to 12 hours light and 12 hours dark. - Vehicle:
- water
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 150 mg + 150 μL analytical Grade Water
- Duration of treatment / exposure:
- 24 hours
- Number of replicates:
- 3
Test system
- Amount / concentration applied:
- 150 mg + 150 μL analytical Grade Water
- Duration of treatment / exposure:
- 24 hours
- Number of animals:
- three skin discs
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- test item
- Value:
- 6.99
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions of this study, it is concluded that the test item 1-Benzyl-5-Phenylbarbituric acid (BPBA) is considered non-corrosive to skin of the rat.
- Executive summary:
1-Benzyl-5-Phenylbarbituric acid (BPBA), was evaluated for its corrosive potential by its ability to produce a loss of normal stratum corneum integrity and barrier function, which was measured as a reduction in the TER below the threshold level (cut-off value) of 5 k Ω for rat skin, and from any increase in the ionic permeability for sulforhodamine B dye.
The skin discs were taken from humanely sacrificed rats aged 28 days and were applied with 150 μL of test item, in triplicate. Concurrent triplicate sets of skin discs were applied either with analytical grade water (150 μl) as negative control or with 10M hydrochloric acid (150 μl) as positive control.
The test and control items were applied for up to 24 hours at 22 °C to the epidermal surfaces of skin discs in a two compartment test system in which the skin disc functioned as the separation between the compartments. The test / control items were then removed by washing with a jet of tap water until no further material could be removed. The skin impedance was measured as TER by using Aplab Autocompute LCR-Q meter 4910. The electrodes of LCR-Q meter were placed on either side of the skin disc to measure the resistance of skin disc at a frequency of 100 Hz and using series values. Following TER measurement, the skin was carefully examined for obvious damage. After visual examination, 10% (w/v) sulforhodamine B was applied to the epidermal surface of each skin disc for 2 hours, which was followed by the measurement of dye content in each skin disc.
The mean resistance of the skin in the negative control group was found to be 10.23 K Ω which was within the acceptable range of 10 to 25 k Ω and the mean dye content of skin disc was 39.13 μg/disc which was closer to the acceptable range of 15 to 35 μg/disc.
The mean resistance of the skin in the positive control group was found to be 1.00 K Ω which was within the acceptable range of 0.5 to 1.0 k Ω while the mean dye content of skin disc was 92.38 μg/disc, which was within the acceptable range of 40 to 100 μg/disc, thereby validating the experimental procedure.
The mean TER value obtained for 1-Benzyl-5-Phenylbarbituric acid (BPBA) was 6.99 K Ω which was greater than 5 k Ω, the skin discs showed no obvious damage (e.g. perforation) and mean disc dye content was found to be 29.84 μg/disc which was lesser than that observed in skin discs treated with the positive control item.
Under the given experimental conditions of this study, it is concluded that the test item 1-Benzyl-5-Phenylbarbituric acid (BPBA) is considered non-corrosive to skin of the rat.
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