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Diss Factsheets
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EC number: 943-330-9 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 19 Jan 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- yes
- Remarks:
- no historical data of positive and negative controls
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROlJPE lNTERMlNISTERIEL DES PRODUITS CHIMIQUES, 67, rue Barbes, 94201 Ivry-sur-Seine CEDEX, France
Test material
- Reference substance name:
- Reaction mass of bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl]adipate and 2-[2-(2-butoxyethoxy)ethoxy]ethyl(3,6,9,12-tetraoxahexadecyl)adipate
- Molecular formula:
- C26H50O10 C28H54O11
- IUPAC Name:
- Reaction mass of bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl]adipate and 2-[2-(2-butoxyethoxy)ethoxy]ethyl(3,6,9,12-tetraoxahexadecyl)adipate
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: EpiOcular™
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- in duplicates for each treatment and contol group
- Details on study design:
- - RhCE tissue construct used, including batch number: EpiOcular™ (OCL-212-ver2.0, supplied by MatTek Corporation), batch No. 23759
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: 30 min exposure (37 °C), 12 min post-exposure immersion (room temperature), 2 h post-exposure (37 °C)
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals: The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water or isopropanol did not lead to a change in colour. Therefore, an additional test with viable tissues without MTT addition was not necessary. Optical evaluation of the MTT-reducing capacity of the test item with MTT-reagent did not show blue colour. Therefore, an additional test with freeze-killed tissues was not necessary.
- Description of the method used to quantify MTT formazan: The absorbance at 570 nm of each well was measured with a microplate reader (model ELx800, BioTek) and the software Gen5 ELISA V1.05.11 (BioTek). No reference wavelength measurement was used.
- Acceptability criteria: 1) Negative control: OD values of the two replicates in the range> 0.8 and< 2.5; 2) Tissues treated with the positive control substance should show a mean tissue viability < 50%; 3) The difference of viability between two tissue replicates should be less than 20% (or the SD between three replicates should not exceed 18%).
- Decision criteria/Prediction model: If the test item-treated tissue viability is > 60% relative to the negative control treated tissue viability, the test item is identified as not requiring classification and labelling for skin irritation. If the test item-treated tissue viability is ≤ 60% relative to negative control treated tissue viability, the test item is identified as potentially requring classification and labelling for skin irritation.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % mean relative absorbance of 2 tissues
- Run / experiment:
- 30 min exposure
- Value:
- 100.32
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria for negative control: The negative control mean OD values (0.684 and 0.585) were not in the range of > 0.8 and < 2.5. Considering the results obtained, this deviation is considered to have no impact on the conclusion of the study.
- Acceptance criteria met for positive control: The mean relative viability of the positive control is below 50% of the negative control viability (5.04%).
- Deviations from acceptability criteria: The difference of viability between 2 tissues for the test item was 34.52%, instead of 20% as initially scheduled. Considering the results obtained, this deviation is considered to have no impact on the conclusion of the study.
Any other information on results incl. tables
Table 1: Results after 30 min incubation time
|
Tissue |
OD |
Mean OD/ disc (#) |
Mean OD/ product |
Viability % |
Meanviability % |
Differenceofviability % |
Conclusion |
|
|
0.758 |
|
|
|
|
|
|
|
I |
0.635 |
0.684 |
|
107.80 |
|
|
|
Negativecontrol |
|
0.659 |
|
0.635 |
|
100.00 |
15.60 |
|
|
0.558 |
|
|
|||||
|
2 |
0.607 |
0.585 |
|
92.20 |
|
|
|
|
|
0.590 |
|
|
|
|
|
|
|
|
0.032 |
|
|
|
|
|
|
|
3 |
0.032 |
0.032 |
|
5.04 |
|
|
|
Positivecontrol |
|
0.033 |
|
0.032 |
|
5.04 |
0.00 |
UN GHS Category 2 or I |
|
0.039 |
|
|
|||||
|
4 |
0.029 |
0.032 |
|
5.04 |
|
|
|
|
|
0.029 |
|
|
|
|
|
|
|
|
0.622 |
|
|
|
|
|
|
|
5 |
0.811 |
0.746 |
|
117.57 |
|
|
|
Test item |
|
0.805 |
|
0.637 |
|
100.32 |
34.52 |
No Category |
|
0.519 |
|
|
|||||
|
6 |
0.517 |
0.527 |
|
83.06 |
|
|
|
|
|
0.545 |
|
|
|
|
|
|
Note: the optical density was measured after a 1:2 dilution of the formazan extracts in isopropanol.
viab > 60% = No Category
viab </= 60% = Irritant
#: :mean of 3 values (triplicate of the same extract)
OD: opticaldensity
Acceptability criteria:
- Negative control: OD values of the two replicates in the range > 0.8 and < 2.5;
- Tissues treated with the positive control substance should show a mean tissue viability < 50%;
- The difference of viability between two tissue replicates should be less than 20% (or the SD between three replicates should not exceed 18%).
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Under the conditions of the conducted test, the test substance is non irritating towards human-derived epidermal keratinocytes in the EpiOcular™ model.
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