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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 834-970-9 | CAS number: 130111-95-4
- 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:
- supporting study
- Study period:
- 03-12-2018 to 07-12-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- propan-2-yl 3-oxocyclobutane-1-carboxylate
- EC Number:
- 834-970-9
- Cas Number:
- 130111-95-4
- Molecular formula:
- C8H12O3
- IUPAC Name:
- propan-2-yl 3-oxocyclobutane-1-carboxylate
- Test material form:
- liquid
- Details on test material:
- Batch (Lot) Number: GR13224
Expiry date: 31 January 2020 (expiry date)
Physical Description: Colourless to pale yellow liquid
Purity/Composition: 99.6%
Storage Conditions: At room temperature
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Source strain:
- not specified
- Details on animal used as source of test system:
- All cells used to produce EpiDerm are purchased or derived from tissue obtained by Matiek Corporation from accredited institutions. In all cases, consent was obtained by these institutions from the donor or the donor's legal next of kin, for use of the tissues or derivatives of the tissue for research purposes.
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm Skin Model (EPI-200, Lot no.: 29642, kit J and K, Appendix 4).
The model consists of normal, human-derived epidermal keratinocytes which have been
cultured to form a multilayered, 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 EpiDerm tissues (surface 0.6 cm2) were cultured on polycarbonate
membranes of 10 mm cell culture inserts.
Source
MatTek Corporation, Ashland MA, U.S.A. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- The liquid test item was applied undiluted (50 µL) directly on top of the tissue.
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- duplicate (two)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- experiment 1 3minute exposure
- Value:
- 84
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- experiment 1: 1 hour exposure
- Value:
- 75
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570
of the two tissues of the negative control should reasonably be
within the laboratory historical control data range.
b) The mean relative tissue viability following 1-hour exposure to the positive control
should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue
replicates should be <= 30%.
The absolute mean OD570 (optical density at 570 nm) of the negative control 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. The mean
relative tissue viability following the 1-hour exposure to the positive control was 4.2%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was
<=11%, indicating that the test system functioned properly
Any other information on results incl. tables
PF-06328566 was checked for color interference in aqueous conditions and possible direct
MTT reduction by adding the test item to MTT medium. Because the solutions did not turn
blue / purple nor a blue / purple precipitate was observed it was concluded that the test item
did not interfere with the MTT endpoint.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability
obtained after the 3-minute and 1-hour treatments with PF-06328566 compared to the
negative control tissues was 84% and 75% respectively. Because the mean relative tissue
viability for PF-06328566 was not below 50% after 3 minutes treatment and not below 15%
after 1 hour treatment PF-06328566 is considered to be not corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, PF-06328566 is not corrosive in the in vitro skin corrosion test under the
experimental conditions described in this report. - Executive summary:
The objective of this study was to evaluate PF-06328566 for its ability to induce skin
corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The
possible corrosive potential of PF-06328566 was tested through topical application for
3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC
guidelines.
Batch GR13224 of PF-06328566 was a colourless to pale yellow liquid. PF-06328566 was
applied undiluted (50 µL) directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 4.2% after the 1-hour exposure.
The absolute mean OD570
(optical density at 570 nm) of the negative control 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. In the range of 20 - 100%
viability the Coefficient of Variation between tissue replicates was <_ 11%, indicating that the
test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The
relative mean tissue viability obtained after 3-minute and 1-hour treatments with
PF-06328566 compared to the negative control tissues was 84% and 75%, respectively.
Because the mean relative tissue viability for PF-06328566 was not below 50% after the
3-minute treatment and not below 15% after the 1-hour treatment PF-06328566 is considered
to be not corrosive.
In conclusion, PF-06328566 is not corrosive in the in vitro skin corrosion test under the
experimental conditions described in this report.
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.