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EC number: 949-812-5 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date: 24 October 2018 and Experimental Completion Date: 25 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- yes
- Remarks:
- see below (deviation was considered to have not affected the integrity or validity of the study)
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.40bis of Commission Regulation (EC) No 440/2008, of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006, 18 December 2006, of the European Parliament and of the Council on the REACH.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated, ethoxylated
- EC Number:
- 949-812-5
- Molecular formula:
- C12H27N(C3H6O)n(C2H4O)m, C14H31N(C3H6O)n(C2H4O)m
- IUPAC Name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated, ethoxylated
- Test material form:
- liquid
- Details on test material:
- Name: XTJ-785, experimental
Lot No.: 9570-2-6738
CAS No.: Not listed
Purity: >92% C1214 alcohol, propoxylated, aminated, ethyoxylated
Expiry Date: No date established
Constituent 1
In vitro test system
- Test system:
- other: EpiDerm™ Reconstructed Human Epidermis Model
- Source species:
- human
- Cell type:
- other: Epithelial, derived from human skin and fromed into a stratified, cornified epithelium
- Cell source:
- other: not available
- Source strain:
- not specified
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- This model incorporates several features, which make it advantageous in the study of potential dermal corrosivity. The target cells are epithelial, derived from human skin, and formed into a stratified, cornified epithelium. Test items are applied to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- used as supplied
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received :23 October 2018
EpiDermTM Tissues (0.63cm2) lot number : 28685
Assay Medium lot number : 1018188MSA
Upon receipt of the EpidermTM tissues, the sealed 24 well plate was stored in a refrigerator until use.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds, to gently remove any residual test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/L MTT solution
- Incubation time: 60 minutes
- Wavelength: 570 nm
- Labtech LT-4500 microplate reader and LT-com analysis software.
NUMBER OF REPLICATE TISSUES: duplicate for test item, duplicate for positive and duplicate for negative control
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: The test item was found to directly reduce MTT and therefore additional non-viable tissues were incorporated into testing for correction purposes..
Qualitity criteria:
The results of the assay are considered acceptable if the following assay acceptance criteria are achieved:
Negative Control
- The absolute OD570 of the negative control treated tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. The mean OD570 of the two negative control tissues should be ≥ 0.8 and ≤ 2.8 for each exposure time, which ensures that the tissue viability meets the acceptance criteria.
Positive Control
- Potassium Hydroxide 8.0N solution is used as a positive control. An assay meets the acceptance criterion if mean relative tissue viability of the 60 Minute positive control is < 15%.
Coefficient of Variation
- In the range 20 and 100% viability, the Coefficient of Variation between tissue replicates should be ≤ 30%.
DECISION CRITERIA:
STEP 1
< 50% after 3 min exposure Corrosive
≥ 50% after 3 min exposure AND < 15% after 60 min exposure Corrosive
≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure Non-corrosive
STEP 2 for test items identified as corrosive in step 1
< 25% after 3 min exposure H314
Sub-category 1A
≥ 25% after 3 min exposure H314
Combination of sub-categories 1B-and-1C - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 60 minutes
3 minutes - Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- duplicate for test item
duplicate for negative control
duplicate for positive control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: relative mean viability
- Run / experiment:
- exposure period 3 minutes
- Value:
- 91.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non corrosive to the skin
- Irritation / corrosion parameter:
- other: relative mean viability
- Run / experiment:
- exposure period 60 minutes
- Value:
- 89.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive to the skin
- Other effects / acceptance of results:
- Results:
An assessment found the test item was able to directly reduce MTT. Therefore, an additional procedure using freeze killed tissues was performed. However, the results obtained showed that negligible interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the freeze killed tissues for quantitative correction of results or for reporting purposes.
Assessment of Color Interference with the MTT endpoint
The solution containing the test item did not become colored.
This was taken to indicate the test item did not have the potential to cause color interference.
Test Item, Positive Control Item and Negative Control Item.
Exposure Period Percentage Viability
Negative Control Positive Control Test Item
3 minute 100* 3.7 91.6
60 minute 100* 2.9 89.2
*The mean viability of the negative control tissues is set at 100%
Quality Criteria:
- The mean OD570 for the negative control treated tissues was 1.931 for the 3 Minute exposure period and 1.923 for the 60 Minute exposure period. The negative control acceptance criteria were therefore satisfied.
- The relative mean tissue viability for the positive control treated tissues was 0.055% relative to the negative control following the 60 Minute exposure period. The positive control acceptance criterion was therefore satisfied.
- In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Calcul:
Relaive mean viability (%) = (mean OD570 of test item / mean OD570 of negative control) x 100
The relative mean viabilities for each treatment group were as follows:
Exposure Period |
Percentage Viability |
||
Negative Control |
Positive Control |
Test Item |
|
3 minute |
100* |
3.7 |
91.6 |
60 minute |
100* |
2.9 |
89.2 |
*The mean viability of the negative control tissues is et at 100%
Mean OD570Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Tissue |
Exposure Period |
MeanOD570of individual tissues |
Mean OD570of duplicate tissues |
Standard Deviation |
Coefficient of Variation |
Relative Mean Viability (%) |
Negative Control |
3 Minutes |
1.985 |
1.931 |
0.077 |
4.0 |
100* |
1.876 |
||||||
60 Minutes |
1.822 |
1.923 |
0.142 |
7.4 |
||
2.023 |
||||||
Positive Control |
3 Minutes |
0.076 |
0.071 |
0.007 |
na |
3.7 |
0.066 |
||||||
60 Minutes |
0.056 |
0.055 |
0.001 |
na |
2.9 |
|
0.054 |
||||||
Test Item |
3 Minutes |
1.691 |
1.769 |
0.110 |
6.2 |
91.6 |
1.846 |
||||||
60 Minutes |
1.650 |
1.716 |
0.093 |
5.4 |
89.2 |
|
1.781 |
OD=Optical density
*= The mean percentage viability of the negative control tissue is set at 100%
na= Not applicable
Relative mean % tissue viability = (Mean OD570 of test item / mean OD570 of negative conrol) x 100
Coefficient of variation = (standard deviation / mean OD570 of duplicate tissues) x 100
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be non-corrosive to the skin.
- Executive summary:
The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. The test item was found to directly reduce MTT and therefore additional non-viable tissues were incorporated into the testing for correction purposes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT‑loading. After MTT-loading each tissue was placed in 2 mL of Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 mL samples were transferred to the appropriate wells of a pre-labeled 96‑well plate. The optical density (OD) was measured at 570 nm (OD570).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viabilities for each treatment group were as follows:
Exposure Period
Percentage Viability
Negative Control
Positive Control
Test Item
3 minute
100*
3.7
91.6
60 minute
100*
2.9
89.2
*The mean viability of the negative control tissues is set at 100%
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion
The test item was considered to be non-corrosive to the skin.
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