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EC number: 500-740-9 | CAS number: 162492-07-1
- 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:
- From January 16, 2017 to January 20, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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: Commission Regulation (EU) No. 1152/2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hexamethylene diisocyanate, oligomers, reaction products with 3-methoxypropylamine
- EC Number:
- 500-740-9
- EC Name:
- Hexamethylene diisocyanate, oligomers, reaction products with 3-methoxypropylamine
- Cas Number:
- 162492-07-1
- Molecular formula:
- C38H69N9O9
- IUPAC Name:
- Hexamethylene diisocyanate, oligomers, reaction products with 3-methoxypropylamine
Constituent 1
- Specific details on test material used for the study:
- CAS No. 162492-07-1; EINECS No:. 500-740-9; Batch No.: 1591ZG-101; Purity >98 %; Appearance: homogeneous white powder
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDermTM tissues
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, 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 representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Origin:
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-212-SIT - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- One plate was used as negative control; each tissue was treated with 30 μL DPBS buffer, a nylon mesh was added in order to ensure sufficient contact with the tissue surface. One plate was used as positive control; each tissue was treated with 30 μL 5% SDS solution, a nylon mesh was added in order to ensure sufficient contact with the tissue surface.
One plate was used for treatment with the test substance:
For each plate, 3 tissues were used. The tissues were wetted with 25 μL DPBS buffer before applying the test substance and spreading it to match the tissue size.
The following amounts were applied to the tissues:
Replicate 1: 25.3 mg
Replicate 2: 25.1 mg
Replicate 3: 25.6 mg - Duration of treatment / exposure:
- 1 h
- Duration of post-treatment incubation (if applicable):
- 23 h and 30 min
- Number of replicates:
- 3 replicates
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 99.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Results:
% Tissue viability (tissue 1): 99.9%
% Tissue viability (tissue 2): 99.9%
% Tissue viability (tissue 3): 98.4%
% Tissue viability (mean) 99.4%
Tissue Viability
The photometric absorbance of the negative controls is considered as 100%. For each replicate of test substance and positive control, tissue viability is calculated as % photometric absorbance compared with the mean of the negative controls:
% Tissue Viability = (OD replicate test substance resp. positive control x 100%) / OD negative controls
Acceptance of the results:
- The test substance is considered as non-irritant to skin.
- After the treatment, the relative absorbance values were reduced to 99.4%. This value is above the threshold for skin irritation (50%).
- The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
- The positive control has met the acceptance criterion too, demonstrating the validity of the test system.
- Variation within replicates was within the accepted range for negative control, positive control and test substance (required: ≤ 18%).
Validity:
OD of negative control: 2.0 (Required: ≥ 0.8 and ≤ 2.8)
% Tissue viability of positive control SDS: 1.8% (Required: ≤ 20% of negative control)
SD of mean viability of the tissue replicates (%):
0.6% (negative control)
0.2% (positive control)
0.8% (test substance)
(Required: ≤ 18%)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, after the treatment with the test substance, the relative absorbance values were reduced to 99.4 %. This value is above the threshold for skin irritation potential (50%). Therefore, the test substance is considered as non-irritant to skin in the Reconstructed Human Epidermis (RhE) test method.
- Executive summary:
A study was conducted to determine the skin corrosion potential of the test substance using the Reconstructed Human Epidermis (RHE) test method according to OECD Guideline 439, in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated with the test substance for 60 min. The substance was applied directly to each tissue and spread to match the tissue size (0.63 cm2). DPBS-buffer was used as negative control, 5% SDS solution as positive control. After treatment with the test substance or the positive / negative control, cell viability of the tissues was evaluated by addition of MTT. The absorbance values for the negative control were within the required acceptability range (OD = 2.0). The positive control showed clear irritating effects (elative absorbance was reduced to 1.8%). Variation within the tissue replicates was acceptable. Under the study conditions, after the treatment with the test substance, the relative absorbance values were reduced to 99.4 %. This value is above the threshold for skin irritation potential (50%). Therefore, the test substance is considered as non-irritant to skin in the Reconstructed Human Epidermis (RhE) test method (Andres, 2017).
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