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Diss Factsheets
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EC number: 243-500-6 | CAS number: 20073-51-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March to April 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
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
- EC Number:
- 243-500-6
- EC Name:
- 2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
- Cas Number:
- 20073-51-2
- Molecular formula:
- C25H46N2O5
- IUPAC Name:
- 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-nonylphenol
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This study addresses the human health endpoint skin irritation. It makes use of reconstructed
human epidermis (RhE) (obtained from human derived non-transformed epidermal keratinocytes)
which closely mimics the histological, morphological, biochemical and physiological properties
of the upper parts of the human skin, i.e., the epidermis. The use of reconstructed human
epidermis (RhE) is also recommended by the OECD and other regulatory authorities. SkinEthic
RHE model has been validated and is part of OECD validated reference methods (VRMs) and is
also a recommended model for conducting in vitro skin irritation studies. The results of the study
are believed to be of value in predicting the potential of inducing skin irritation by the test item in
humans.
- Details on test system:
- The test system used for the in vitro skin irritation test was reconstructed human epidermis RHE model
consists of normal human keratinocytes cultured for 17-days on an insert of 0.5 cm
polycarbonate filter at the air-liquid interface in a chemically defined growth medium. The cells
form a multilayered, highly differentiated and stratified epidermis model of the human epidermis
that consists of main basal, supra basal, spinous and granular layers and a functional stratum
corneum.
RHE model, were procured from SkinEthic Laboratories, Episkin 4, Rue Alexander Fleming, 69366 Lyon
Cedex 07, France; were used in the study (Lot N°19-RHE-027, APPENDIX 5). - Control samples:
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 16 µL/0.5 cm2
- Duration of treatment / exposure:
- 42 min.
- Duration of post-treatment incubation (if applicable):
- 42 min.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 1.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results of this study, the classification for POLIOL MB 600 is as mentioned below:
Globally Harmonized System of Classification and Labelling of Chemicals: Category 2 (Skin Irritant)
- Executive summary:
This study was performed to evaluate the non-irritant and irritant potential of
POLIOL MB 600 using reconstructed human epidermis (RHE) tissue in accordance with the United Nations
Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).
Tissues were exposed to the negative control (Dulbecco’s Phosphate Buffered Saline (DPBS), positive
control (sodium dodecyl sulfate, 5% aqueous (SDS)) and POLIOL MB 600 in triplicate for 42 minutes at
room temperature.
The mean cell viability in tissues treated with the test item was 1.9% after 42 minutes exposure. A
significant reduction in percent cell viability was observed in treated tissues when compared with that of the
concurrent negative control.
The Optical density (OD) values for the negative control replicates were between 1.633 and 1.853, against
the guideline requirement of ≥ 0.8 and ≤ 3.0 (≥ 1.2 as per SkinEthic SOP). The OD of the blank was
between 0.040 and 0.044 which met the guideline requirement of OD < 0.1. The positive control showed
a 1% cell viability, against the acceptance criteria of <40% for the SkinEthic RHE model, when compared
with that of the concurrent negative control. Variation between tissue replicates (i.e., CV% value) was
17.00% for positive control and 6.46% for negative control against the guideline requirement of ≤ 18%,
which demonstrate the efficiency of the test system, SkinEthic
replicates (i.e., CV% value) was 20.21% for the test item group. All criteria for a valid study were met as
describe in the study plan.
Based on results of this study, the classification for POLIOL MB 600 is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals :
Category 2 (Skin Irritant)
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.
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