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Diss Factsheets
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EC number: 460-230-6 | 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:
- 10 July 2012 - 28 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Operating Procedure, In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009), supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): EP-4000S, Chemical name: Phenol,4-4’-(1-methylethylidene)bis-,polymer with 2-(chloromethyl)oxirane and 2-methyloxirane
- Physical state: Light yellow liquid
- Analytical purity: 100%
- Lot/batch No.: 902Y1
- Expiration date of the lot/batch: 7 December 2012
- Storage condition of test material: Room temperature, in the dark
Test animals
- Species:
- other: EPISKIN three-dimensional human skin model.
- Details on test animals or test system and environmental conditions:
- The test involves the application of the test substance for 15 minutes to the EPISKIN three dimensional human skin model. The model consists of normal,
human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen.
After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum
has formed. The epidermis surface area supplied is 0.38cm2.
The EPISKIN kits include
assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar.
Test system
- Controls:
- other: Please refer to above entry
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL applied over each tissue using a positive displacement pipette - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Observation period:
- After 15 ± 0.5 minutes of exposure of the test substance, each tissue was rinsed and the inserts were blotted on absorbent paper to remove remaining sterile Dulbeccos Phosphate Buffered Saline (DPBS), rinsing agent. Each insert was then transferred to a well containing 2 mL maintenance medium and incubated for 42 ± 1 hour at 37°C ± 2 °C in a humidified atmosphere of 5% CO2 in air.
After 42 ± 1 hour, each insert was transferred to a well containing 2 mL of 0.3 mg/mL MTT and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. - Number of animals:
- The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium.
The positive control was 5% Sodium Dodecyl Sulphate (SDS) in distilled water. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):each tissue was rinsed with 25 mL sterile Dulbeccos Phosphate Buffered Saline (DPBS)
- Time after start of exposure: 15 ± 0.5 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Mean tissue viability
- Value:
- 56.4
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: Predicted as non-irritant. (migrated information)
In vivo
- Irritant / corrosive response data:
- The test substance, EP-4000S/water solution and water control were colourless after the 15 minute shaking period. The test substance, EP-4000S, had not shown any potential for colouring water.
- Other effects:
- There was no change in the test substance, EP-4000S/MTT solution or the water control/MTT solution after three hours incubation in the dark at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. The test substance had not interacted with the MTT.
Any other information on results incl. tables
The results of the assay are summarised below:
Sample | Tissue viability as percentage of mean OD negative control | Prediction MTT endpoint | |||
Replicate Tissues |
Mean +/- SD | ||||
a | b | c | |||
Negative control | 102.1 | 98.0 | 99.9 | 100.0 ± 2.0 | Not applicable |
Positive control | 13.8 | 16.5 | 34.5 | 21.6 ± 11.3 | Irritant |
EP-4000S | 60.8 | 60.7 | 47.7 | 56.4 ± 7.5 | Non-irritant |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded that the test substance, EP-4000S, with a mean tissue viability of 56.4 ± 7.5%, was predicted as non-irritant to the skin.
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