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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- From 29 January 2019 to 6 February 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- OECD Test Guideline 431 (reconstructed human epidermis
(RHE) Test Method) - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid
- Molecular formula:
- not applicable - the substance is an UVCB
- IUPAC Name:
- 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- N/A
- Justification for test system used:
- The EpiDerm TM skin model and assay for skin corrosion testing is endorsed by OECD TG 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM (EPI-200) Reconstructed Human Epidermis
- Tissue batch number(s): 28682
- Delivery date: 05/02/2019
- Date of initiation of testing: 05/02/2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: not specified
- Incubation time: pre-incubated at 37°C for 1 hour
- Spectrophotometer: BMG LabTech FluoStar Optima
- Wavelength: 570 nm (no reference filter)
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 2.049 ± 0.023 OD. PASS.
- Barrier function: 5.3hrs. PASS.
- Morphology: 12 layers present, 101.2 µm tissue thickness. PASS.
- Contamination: No contamination. PASS.
NUMBER OF REPLICATE TISSUES: n=3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Prior to the assay, the test item was checked for interference (water colouration or MTT interference) and found not to interfere.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430: In accordance with TG 431. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
- Concentration (if solution): neat
- Application: push-pin applicator
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl
- Concentration (if solution): neat
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl
- Concentration (if solution): 8.0N - Duration of treatment / exposure:
- 3 and 60 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 111.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 95.24
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Colour interference with MTT: Checked, no interference.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: mean OD570 must be >0.8. - PASSED
- Acceptance criteria met for positive control: mean of the positive control relative percentage viability, after 1hour exposure must be < 15% of the mean of the negative control. - PASSED
- Acceptance criteria met for variability between replicate measurements: In the range between 20% and 100% viability, the coefficient of variation (CV) is an additional acceptance criterion. It should not exceed 0.3 (30%). - PASSED
Any other information on results incl. tables
see attached background documents.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid was evaluated for skin corrosion. The substance did not meet the criteria for classification as corrosive to the skin.
- Executive summary:
A GLP-compliant in-vitro skin corrosion study was carried out on 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid using the EpiDermTM Reconstructed Human Epidermis (RHE) tissue model. The study was performed following OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test). The aim of the test was establish whether 4,4’-isopropylidenediphenol, reaction products with 1-chloro-2,3-epoxypropane, mono, di and triesters with acrylic acid has or does not have a corrosive effect on skin, and to what extent. This was done for the purposes of providing a rational basis for a risk assessment.
A single topical application of 25mg of neat test item and 50µl of each reference item were applied to the surface of the EpiDermTM skin models using push-pin applicators. This was left for 3 and 60 minutes under the following conditions: 37°C, 5% CO2, ≥95% Relative Humidity. Three tissues were used per condition.
The results were that the mean tissue viability of the reconstructed human epidermis remained above 50% at 3 minutes (111.30%) and 15% at 60 minutes (95.24%). The substance did not meet the criteria for classification as corrosive to the skin in accordance with Regulation (EC) No.1272/2008.
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