Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 816-326-9 | CAS number: 15517-46-1
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 September 2017 - 13 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study has been performed according to OECD and/or EC guidelines and acc ording to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test".
- Version / remarks:
- Official Journal of the European Union No. L142, 31 May 2008.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate dated 3 November 2015. Dates of the inspection: 7 - 11, 14 and 16 September 2015.
Test material
- Reference substance name:
- 4-[4-(4-hydroxybenzoyl)benzoyl]phenol
- EC Number:
- 816-326-9
- Cas Number:
- 15517-46-1
- Molecular formula:
- C20H14O4
- IUPAC Name:
- 4-[4-(4-hydroxybenzoyl)benzoyl]phenol
- Test material form:
- solid: crystalline
- Details on test material:
- - Identification: 1,4-Bis (4-hydroxy benzoyl) benzene
- Appearance: Off white crystalline powder
- Test item storage: At room temperature
- Stable under storage conditions until: 15 May 2018 (expiry date)
Constituent 1
- Specific details on test material used for the study:
- - Appearance: Off white crystalline powder
- Test item storage: At room temperature
- Stable under storage conditions until: 15 May 2018 (expiry date)
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model
- Source species:
- human
- Cell type:
- other: normal, human-derived epidermal keratinocytes
- Cell source:
- other: MatTek Corporation, Ashland MA, U.S.A.
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model, EPI-200
- Tissue batch number(s): 27144 Kit I and Kit J
TEMPERATURE USED FOR TEST SYSTEM
- Temperature of pre-incubation: 37°C
- Temperature used during treatment / exposure: 3 minutes or 1 hour at room temperature (26.4-27.6°C)
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Volume of phosphate buffered saline and number of washing steps not specified
- Observable damage in the tissue due to washing: None
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/ml) diluted (1:5) with MTT diluent (supplemented DMEM)
- Incubation time: 3 hours at 37°C in air containing 5% CO2
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: MTT QC assay, 4 hours, n=3: OD (540-570 nm)= 1.989+/-0.122 [Acceptance criteria: 1.0-3.0]
- Barrier function: ET-50 assay, 100 µL 1% Triton X-100, 4 time-points, n=3, MTT assay: ET-50= 6.21 hrs [Acceptance criteria: 4.77-8.72 hrs]
- Morphology: Presence of a functional stratum corneum, a viable basal cell layer, and intermediate spinous and granular layers
- Contamination: No contamination
NUMBER OF REPLICATE TISSUES: 4 (Two tissues were used for a 3-minute exposure to the test item and two for a 1-hour exposure) or 2 (2 tissues for negative control and 2 tissues for positive control)
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- None, the test item did not interfere with the MTT endpoint.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- A test item is considered corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability >= 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
- A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25.3 to 31.2 mg of the solid test item directly applied on top of the skin tissue after moisture with 25 µl Milli-Q water.
VEHICLE
- No vehicle
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8.0 N - Duration of treatment / exposure:
- 3 minutes or 1 hour
- Number of replicates:
- 4 (two tissues for a 3-minute exposure to the test item and two for a 1-hour exposure) or 2 (two tissues for negative control and two tissues for positive control)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute exposure
- Value:
- 116
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 11%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1-hour exposure
- Value:
- 98
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 7.6%
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes [mean OD570 of the two tissues within the laboratory historical control data range: 1.324-2.615 (3-minute exposure) or 1.361-2.352 (1-hour exposure)]
- Acceptance criteria met for positive control: Yes [mean relative viability following 1-hour exposure < 15%]
- Acceptance criteria met for variability between replicate measurements: Yes [in the range 20 - 100% viability, CV =< 30%]
- Range of historical values if different from the ones specified in the test guideline:
Negative control (3-minute treatment, OD570): 1.324 - 2.615
Negative control (1-hour treatment, OD570): 1.361 - 2.352
Positive control (3-minute treatment, OD570): 0.0172 - 0.56
Positive control (1-hour treatment, OD570): 0.046 - 0.339
Historical data range obtained by collecting all data over the period of November 2013 to November 2016.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance, 1,4-Bis (4-hydroxy benzoyl) benzene, is not corrosive to the skin.
- Executive summary:
The assessment of the corrosive potential to skin of 1,4-Bis (4-hydroxy benzoyl) benzene was carried out, under GLP compliance, using an in vitro skin corrosive test based on the guidelines described in: OECD No. 431 (adopted 29 July 2016) and EU Method B.40 BIS.
The test consisted of topical application of 1,4-Bis (4-hydroxy benzoyl) benzene (25.3 to 31.2 mg of the solid test item with 25 µl Milli-Q water) on the skin tissue for 3-minute and 1 -hour exposure. After exposure the skin tissue was thoroughly rinsed to remove the test item followed by immediate determination of the cytotoxic (corrosive) effect.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment.
The test item did not interfere with the MTT endpoint. The positive control (Potassium hydroxide) had a mean relative tissue viability of 7.6% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control (Milli-Q water) tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit =<2.8) and the laboratory historical control data range (actual range 1.4955 – 1.8957). In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was =< 5.7%, indicating that the test system functioned properly.
The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with 1,4-Bis (4 -hydroxy benzoyl) benzene compared to the negative control tissues was 116% and 98% respectively.
Because the mean relative tissue viability for 1,4-Bis (4 -hydroxy benzoyl) benzene was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, 1,4-Bis (4-hydroxy benzoyl) benzene is considered to be non-corrosive in the performed experiment. The substance is not classified as corrosive to skin according to UN-GHS criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.