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EC number: 700-772-5 | CAS number: 1190961-28-4
- 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:
- between 08 November 2011 and 11 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Principles of method if other than guideline:
- The principle of the assay is based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-la and IL-8 in the culture medium retained following the incubation period could be measure to determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the non-irritant result.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- EC Number:
- 700-772-5
- Cas Number:
- 1190961-28-4
- Molecular formula:
- N/A - too complex
- IUPAC Name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- Test material form:
- other: liquid
- Details on test material:
- - Substance type: UVCB
- Physical state: clear extremely pale straw coloured viscous liquid
- Analytical purity:100% UVCB
- Lot/batch No.: 010154379
- Expiration date of the lot/batch: 06/17/2012
- Storage condition of test material: room temperature in the dark
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- The SkinEthic RHE model incorporates several features which make it advantageous in the study of skin irritancy potential. The model consists of an airlifted, living, multi-layered epidermal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium, featuring normal ultra-structure and functionally equivalent to human epidermis in vivo. Test items are applied directly to the culture surface, at air interface, so that undiluted and/or end use dilutions can be tested directly.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE Model by SkinEthic Laboratories, Nice, France
- Tissue batch number(s): 11 022A 1006
- Delivery date: 08 November 2011
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37C
- Temperature of post-treatment incubation (if applicable): 37C
REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the relevant exposure period, each tissue insert was removed from the well using forceps and rinsed using a wash bottle containing DPBS. Rinsing was achieved by filling and emptying each tissue insert, over approximately 40 seconds, using a constant soft stream of DPBS to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the insert with absorbent paper. Each tissue was placed into a pre-labelled 24-well plate designated 'holding plate' containing 300 pl of maintenance medium until all the tissues were rinsed (including the duplicate negative and positive control tissues).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.5mg/ml
- Incubation time: 3 hours at 30C, 5% CO2 in air
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 540nm
NUMBER OF REPLICATE TISSUES:
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
50 pl of the test item was added to 1 ml of a 0.5 mg/ml MTT solution freshly prepared in maintenance medium and incubated at 370C, 5% C02 in air for 3 hours. Untreated MTT solution was used as a control. If the MTT solution colour turned blue relative to the control, the test item was presumed to have reduced the MTT. Water insoluble test items may show direct reduction (darkening) only at the interface between the test item and the medium.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
The mean tissue viabilities obtained after the 4-hour and 24-hour exposure periods were compared to the respective negative control and classified according to the following:
Mean tissue Viability Prediction
4hrs: <60 Irritant
4 hours: 60-90 Mild-moderate Irritant
24 hours: >60 Mild-moderate Irritant
24 hours >90 Mild-moderate Irritant - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 4 hours/24 hours
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 3
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control and Triton X-100 (0.1% w/v) was used as the positive control (this is an in vitro test)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 ul test material
VEHICLE: none - Duration of treatment / exposure:
- 4 and 24 hours
- Number of animals:
- Triplicate tissues for test material;
Duplicate tissues for positive and negative control groups. - Details on study design:
- TEST Tissue was cultured in a 6 well plate.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 4 an d24 hours after applications
SCORING SYSTEM: MTT assay
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4 hour
- Value:
- 98.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 24 hour
- Value:
- 91.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Assessment of Direct Test Item Reduction of MTT
The solution did not turn blue. This was taken to indicate that the test item was not able to directly reduce MTT.
Assessment of Skin Irritation Potential
The relative mean viability of the test item treated tissues was 98.1 % after the 4-Hour exposure period and 91.6 % after the 24-Hour exposure period.
It was considered unnecessary to proceed with tissue histology or analysis of inflammatory mediator levels.
Assay Acceptance Criterion
The positive control induced a response of <60% (mild-moderate irritation) after the 24- Hour exposure period relative to the negative control treated tissues and therefore the results of the study were considered acceptable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was considered to be Non-Irritant.
- Executive summary:
Introduction
The purpose of this study was to determine the skin irritation potential of the test item using the SkinEthic Reconstructed Human Epidermal model (RHE, SkinEthic Laboratories, Nice, France) following exposure periods of 4 and 24 hours. The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic RHE model and are sufficiently cytotoxic to cause cell death in the underlying cell layers.
Methods
The experimental design of the study consists of a test for direct reduction of MTT by the test item, followed by the main test.
For the main test, triplicate SkinEthic tissues were treated with approximately 50ul of test item and exposed for 4 hours and 24 hours. The tissues were incubated at 37°C in a humidified atmosphere of 5% C02 in air for the appropriate exposure times.
Duplicate tissues treated with sterile water were used for each exposure period to serve as negative controls. Duplicate tissues treated with 50 I of Triton X-100 (0.1% w/v) were used for the 24-Hour exposure period to serve as a positive control.
At the end of the 4-Hour exposure period each SkinEthic tissue was rinsed using Dulbecco's Phosphate Buffered Saline (DPBS) and placed into a 'holding plate' until all the tissues had been rinsed. The rinsed tissues (2 per group) were then transferred to an MTT 'loading plate' and incubated at 37°C for 3 hours in a humidified atmosphere of 5% C02 in air. At the end of this time, each SkinEthic tissue was blotted dry and placed into an MTT 'extraction plate' in order to extract all of the reduced MTT from the tissues. The remaining test item treated tissue was retained for possible histology. The same rinsing, loading, extraction and retention procedures were repeated for the 24-Hour tissues once the 24-Hour exposure period was complete. The maintenance medium in each well of the 4 and 24-Hour exposure period treatment plates were retained for possible analysis of inflammatory mediator levels of IL-1a and IL-8.
At the end of the extraction period, the extracted MTT solution was mixed for each SkinEthic tissue and 3 x 200 !JI samples representing each tissue were transferred to the appropriate wells of a 96 well plate. The optical density at 540nm (00540) of each well was measured. Data are presented in the form of percentage viability (MTT conversion relative to negative controls) for each of the two exposure periods.
The results were used in order to make a prediction of skin irritation potential.
Results
The relative mean viability of the test item treated tissues was 98.1 % after the 4-Hour exposure period and 91.6% after the 24-Hour exposure period.
It was considered unnecessary to proceed with tissue histology or analysis of inflammatory mediators.
Conclusion
The test item was considered to be a Non-Irritant.
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