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EC number: 904-155-3 | 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3rd July - 19th November 2012.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant and conducted in accordance with testing guidelines.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Scientific Advisory Committee (ESAC) Statement on the Validity of In Vitro Tests for Skin Irritation (2007)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Skin Irritation Validation Study. Validation of the EpiSkin® Irritation Test – 42 Hours Assay for the Prediction of Acute Skin Irritation of Chemicals,
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Skin Irritation Validation Study (SIVS). Performance Standards for Applying Human Skin Models to In Vitro Skin Irritation Testing (2007).
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6-diethyl-2,6-bis(hydroxymethyl)heptane-1,3,5,7-tetrol; 2-ethyl-2-(hydroxymethyl)propane-1,3-diol; 2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol
- EC Number:
- 904-155-3
- Molecular formula:
- C12H28O6 C12H26O5 C6H14O3
- IUPAC Name:
- 2,6-diethyl-2,6-bis(hydroxymethyl)heptane-1,3,5,7-tetrol; 2-ethyl-2-(hydroxymethyl)propane-1,3-diol; 2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): HB TMP
- Analytical purity: 69%
- Composition of test material, percentage of components: 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol] (CAS: 23235-61-2, EC No.: 245-509-0), Propylidynetrimethanol (CAS: 77-99-6, EC No.: 201- 074-9) and 2,2'-[methylenebis(oxymethylene)]bis[2-ethylpropane-1,3-diol] (CAS: 93983-16-5, EC No.: 301-304-9).
- Lot/batch No.: 7LTQA002
- Expiration date of the lot/batch: 8th May 2014
- Storage condition of test material: Stored at ambient temperature in the dark when not in use.
Constituent 1
Test animals
- Species:
- human
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Not applicable as no test animals were used.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: ultra pure water.
- Controls:
- other: Control substances were used.
- Amount / concentration applied:
- Approximately 12mg HB TMP was applied.
- Duration of treatment / exposure:
- 15 minutes.
- Observation period:
- Not applicable.
- Number of animals:
- Not applicable as study was conducted using EpiSkin Irritation test.
- Details on study design:
- Prior to conducting the irritation assay, a preliminary test was conducted to assess the intrinsic ability of the test item to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan. HB TMP did not reduce MTT to formazan.
12mg HB TMP was loaded onto the underside of 3 cylindrical metal weights using a microspatula. The HB TMP was applied to the cylindrical weights so that the entire underside was covered with the test item. After loading, the total weight of the HB TMP and cylindrical weight was recorded. Triplicate EpiSkin® units were dosed by applying the weights (HB TMP side down) onto the EpiSkin® surface. Prior to dosing, the EpiSkin surface was moistened by applying 5 μL of water. The weights were gently massaged onto the EpiSkin® surface over the course of the exposure (every 2 min) to ensure good contact between the HB TMP and the exposed EpiSkin® tissues. During the exposure period, most of the test item was transferred from the underside of the cylindrical weight onto the EpiSkin® surface, forming a homogenous liquid that was evenly distributed over the entire exposed area. The cylindrical weights were reweighed after dosing to confirm the dose transferred to the EpiSkin®. For all units the applied dose within the defined limits (10 mg ± 2 mg).
The surface area of the EpiSkin® was ca 0.38 cm2. Therefore, the mean application rate was 26.3 μL/cm2 for the controls and ca 26.3 mg/cm2 for HB TMP.
After the 15 min exposure period, the test item was washed from the surface of the EpiSkin® using Dulbecco’s phosphate-buffered saline (PBS).
The EpiSkin® was then incubated for a recovery period of 41.5 h in a humidified incubator, set to maintain temperature and CO2 levels of 37°C and 5%, respectively. Following incubation, the EpiSkin® units were transferred to assay medium containing MTT (0.3 mg/mL) and returned to the incubator for 3 h. Biopsies of the EpiSkin® membranes were removed, added to acidified isopropanol, and refrigerated for approximately 75 h in order to extract the formazan. The formazan production (cell viability) was assessed by measuring the optical density of the extracts at a wavelength of 550 nm. Three replicates of the positive control, aqueous sodium dodecyl sulphate (SDS) solution (5%, w/v), and the negative control, PBS were tested in parallel to demonstrate the efficacy of the assay. The viability of each
individual EpiSkin® tissue was calculated as a percentage of the mean negative control viability (defined as 100%).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- For the HB TMP test, the results were similar for the three viable EpiSkin® units dosed with HB TMP. Exposure to HB TMP resulted in a mean EpiSkin® viability of 100.57% ± 3.17% of the negative control value.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Evaluation of Direct Reduction of MTT (Prelimiary Assay).
Treatment |
Replicate ID |
Weight/volume Applied |
Colour change observed |
Treatment reduces MTT? |
HB TMP |
Rep 1 Rep 2 Rep 3 |
10mg |
No colour change |
No |
Water (negative control) |
Rep 1 Rep 2 Rep 3 |
10µL |
No colour change |
No |
Eugenol (positive control) |
Rep 1 Rep 2 Rep 3 |
10µL |
Purple colour change |
Yes |
|
|
|
|
|
Percentage Viability of EpiSkin® Tissues After 41.5 h Recovery Time
Treatment |
Replicate ID |
Relative Viability (%) |
Mean Relative Viability per Tissue (%) |
Mean Relative Viability per Test item (%) |
SD (%) |
PBS Solution (Negative Control) |
Rep 1 |
96.13 |
95.78 |
100.0 |
3.83 |
95.44 |
|||||
Rep 2 |
105.21 |
103.26 |
|||
101.30 |
|||||
Rep 3 |
103.03 |
100.96 |
|||
98.89 |
|||||
Aqueous SDS Solution (5%, w/v) (Positive Control) |
Rep 1 |
13.57 |
13.80 |
14.22 |
3.01 |
14.03 |
|||||
Rep 2 |
11.15 |
11.44 |
|||
11.73 |
|||||
Rep 3 |
17.82 |
17.42 |
|||
17.02 |
|||||
HB TMP |
Rep 1 |
102.91 |
104.06 |
100.57 |
3.17 |
105.21 |
|||||
Rep 2 |
99.92 |
99.81 |
|||
99.69 |
|||||
Rep 3 |
102.11 |
97.85 |
|||
93.60 |
|||||
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this study, HB TMP was determined to be a non-irritating to skin in accordance with GHS classification when tested in the EpiSkin in vitro irritation assay.
- Executive summary:
The skin irritation potential of HB TMP was evaluated using the EpiSkin® in vitro irritation test in accordance with OECD Guideline 439 and ECVAM guidance and GLP compliance.
A preliminary test was conducted to assess the intrinsic ability of the test item to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan. HB TMP did not reduce MTT to formazan.
The dermal irritation potential was assessed by applying 10 mg ± 2 mg of the solid HB TMP to the exposed surface of three EpiSkin® reconstructed human epidermis (RhE) units for 15 min. Prior to applying the test item, the EpiSkin® surface was pre-moistened with sterile, ultra-pure water (5 μL). The surface area of the EpiSkin® was 0.38 cm2, therefore the application rate was ca 26.3 mg/cm2. After the 15 min exposure period, the test item was washed from the surface of the EpiSkin® using Dulbecco’s phosphate-buffered saline (PBS).
The EpiSkin® was then incubated for a recovery period of 41.5 h in a humidified incubator, set to maintain temperature and CO2 levels of 37°C and 5%, respectively. Following incubation, the EpiSkin® units were transferred to assay medium containing MTT (0.3 mg/mL) and returned to the incubator for 3 h. Biopsies of the EpiSkin® membranes were removed, added to acidified isopropanol, and refrigerated for ca 75 h in order to extract the formazan. The formazan production (cell viability) was assessed by measuring the optical
density of the extracts at a wavelength of 550 nm. Three replicates of the positive control, aqueous sodium dodecyl sulphate (SDS) solution (5%, w/v), and the negative control, PBS were tested in parallel to demonstrate the efficacy of the assay. The viability of each
individual EpiSkin® tissue was calculated as a percentage of the mean negative control viability (defined as 100%).
Exposure to HB TMP resulted in a mean EpiSkin® viability of 100.57% ± 3.17% of the negative control value. Exposure to the positive control, aqueous SDS solution (5%, w/v), resulted in a mean EpiSkin® viability of 14.22% ± 3.01% of the negative control value.
In conclusion, HB TMP was demonstrated to be non-irritant in accordance with GHS classification when tested in the EpiSkin® in vitro irritation assay.
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