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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted in according to OECD guideline and GLP without deviation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: B.40 BIS (In vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: oil
- Details on test material:
- - Name of test material : TRIMETILOLPROPANO TRIPELARGONATO
- Molecular formula : C33H62O6
- Molecular weight :554.85 g/mol
- Analytical purity: > 99%
- Composition of test material, percentage of components: Nonanoic acid, 1,1'-[2-ethyl-2-[[(1-oxononyl)oxy]methyl]- 1,3-propanediyl] ester
- Lot/batch No.:P_F54 + P_MAGGIO 2013
- Expiration date of the lot/batch: Nov. 2014
- Storage condition of test material: The test item was stored in a closed vessel at room temperature, protected from light.
- Appearance: clear light-yellowish oil
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: Commercially available Epi-200-Kit.
- Details on test animals or test system and environmental conditions:
- Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories.
Day of delivery: 08. Oct. 2013
Batch EPI-200-CORR: 18381
Chemicals and Media:
- MTT reagent: Contains 1mg/mL 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide, which can be reduced to a blue formazan. Prepared as concentrate (5mg/mL in DPBS buffer, stored at -20 °C).
For the pre-test, the concentration was thawed and diluted with serum-free MEM medium directly before use.
For the main study, the concentrate was thawed and diluted with assay medium directly before use.
Isopropanol 99,9%, batch 3100602 used as exctracting solvent for formazan
Test system
- Details on study design:
- The EpiDerm tissu consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epiderms. It consists of organised 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 are cultured on specially prepared cell cultures inserts. Negative control: Deionised H2O Positive control: KOH, solution in deionised H2O containing 8.0 mol/L
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- dye content (µg/disc)
- Value:
- ca. 98.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The photometric absorption of the negative controls was considered as 100 %. For the mean of the three replicates of test item and positive control. formazan production was calculated as % photometric absorption compared with the negative control.
See table below for assessment
Any other information on results incl. tables
Assessment:
% Formazan productionafter 3 min. incubation time | % Formazan productionafter 1 h incubation time | Assessment |
< 50% of negative control | irrelevant | Corrosive! |
> = 50% of negative control | < 15% of negative control | Corrosive! |
>= 50% of negative control | >= 15% of negative control | not corrosive |
Results:
The absorption values of negative control, test item and positive control are given in the following table:
Negative Control | Test Item | Positive Control | Incubation time | |||||
Tissue 1 | Tissue 2 | Tissue 1 | Tissue 2 | Tissue 1 | Tissue 2 | |||
2.202 | 1.956 | 2.067 | 2.075 | 0.443 | 0.472 | 3 min | ||
2.199 | 1.975 | 2.048 | 2.026 | 0.452 | 0.465 | 3 min | ||
2.166 | 2.074 | 2.038 | 2.079 | 0.452 | 0.459 | 3 min | ||
1.948 | 2.014 | 1.716 | 1.875 | 0.199 | 0.205 | 1 hour | ||
1.986 | 1.924 | 1.750 | 1.916 | 0.198 | 0.203 | 1 hour | ||
1.986 | 2.016 | 1.756 | 1.909 | 0.194 | 0.204 | 1 hour | ||
Mean | Mean | Mean | ||||||
2.095 | 2.056 | 0.457 | 3 min | |||||
1.979 | 1.820 | 0.201 | 1 hour |
Validity:
The criterion for optical density of the negative control (> 0.8) was fulfilled: optical density was 2.095 (3 minutes) resp. 1.979 (1 hour). The positive control showed a clear corrosive effect: the value of the three-minuteexperiment was 21.8 % and the value of the one-hour-experiment was 10.1 %. Values for negative control and for positive control were within the range of historical data of the test facility (see Annex 2: Comparison with Historical Data, page 17). Therefore, the experiment is considered valid.
Discussion:
The test item is considered not corrosive. After three minutes treatment, the relative absorbance values were decreased to 98.1 %. This value is well above the threshold for corrosivity (50 %). After one hour treatment relative absorbance values were reduced to 92.0 %. This value is well above the threshold for corrosivity (15 %). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”. The values of the negative control were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control induced a decrease in the relative absorbance as compared to the negative control to 21.8 % for the three minutes treatment interval and 10.1 % for the one hour treatment interval thus ensuring the validity of the test system. For these reasons, the result of the test is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Trimetilolpropano tripelargonato is considered as "not corrosive in the human Skin Model Test"
- Executive summary:
The study was followed in according to OECD guideline and GLP without significate deviations.
Two tissues of the human skin model EpiDermTM were treated with TRIMETILOLPROPANO TRIPELARGONATO for three minutes and one hour, respectively. 50 μL of the liquid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8M KOH was used as positive control. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution. After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were reduced to 98.1 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 92.0 %. This value, too, is well above the threshold for corrosion potential (15 %). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”.
In according to the OECD guideline 431, TRIMETILOLPROPANO TRIPELARGONATO is considered as “not corrosive in the Human Skin Model Test”.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Aunque la ECHA ofrece una gran cantidad de material en su idioma, una parte de esta página está solo disponible en inglés. Más información sobre la política de multilingüismo de la ECHA.
Bienvenido a la página web de la ECHA. Este sitio no es plenamente compatible con Explorer 7 (y versiones anteriores). Por favor, actualice su Internet Explorer a una versión más reciente.
Esta web utiliza cookies para mejorar su experiencia de navegación en nuestros sitios web.
Más información sobre el uso de cookies.