Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 245-327-1 | CAS number: 22919-56-8
- 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:
- Feb 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The is a OECD 431 guideline study conducted in accordance with GLP on the substance Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1), which has been a Klimisch rating of 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- EC Number:
- 245-327-1
- EC Name:
- Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- Cas Number:
- 22919-56-8
- Molecular formula:
- C8H16O2.C6H15NO3
- IUPAC Name:
- 2-[bis(2-hydroxyethyl)amino]ethan-1-ol; octanoic acid
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Batch 1115-80.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDermTM skin model and assay for skin corrosion testing is endorsed by OECD TG 431.
- Details on test system:
- The reconstructed human epidermal model EpidermTM (EPI-200 MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differential model of the human epidermis. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Single topical application of 50µl of test item, negative control (water) or positive control (potassium hydroxide) was applied to the surface of the EpiDerm(TM) skin models.
- Duration of treatment / exposure:
- 3 and 60 minutes at 37°C, 5% CO2, ≥95% RH (Relative Humidity).
- Number of replicates:
- Three tissues per condition (n=3).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Viability after 3 minutes
- Value:
- ca. 84.23
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Viability after 1 hour
- Value:
- ca. 5.37
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Cell viability measurements after 3 minutes of application.
3 Minute Endpoint |
NC |
PC |
TA1 |
|
Tissue 1 |
Aliquot 1 OD |
2.38 |
0.14 |
2.23 |
Aliquot 2 OD |
2.38 |
0.13 |
2.18 |
|
Tissue 2 |
Aliquot 1 OD |
2.50 |
0.22 |
1.69 |
Aliquot 2 OD |
2.57 |
0.22 |
1.64 |
|
Tissue 3 |
Aliquot 1 OD |
2.31 |
0.06 |
2.21 |
Aliquot 2 OD |
2.30 |
0.07 |
2.22 |
|
All tissues |
Average OD |
2.41 |
0.14 |
2.03 |
Average % Viability |
100.00 |
5.82 |
84.23 |
|
Average % SD |
4.01 |
2.63 |
10.71 |
|
Average % CV |
4.01 |
45.10 |
12.71 |
NC: negative control (H2O), PC: Positive control (KOH 8N), TA1: Octanoic Acid Triethanolamine Salt. *CV value of the PC is above 30% (45.10%) however, as the percentage of viability is below 20% (5.82%) acceptance criterion 3 is met.
Cell viability measurements after 1 hour of application.
1 Hour Endpoint |
NC |
PC |
TA1 |
|
Tissue 1 |
Aliquot 1 OD |
2.18 |
0.12 |
0.15 |
Aliquot 2 OD |
2.20 |
0.11 |
0.14 |
|
Tissue 2 |
Aliquot 1 OD |
2.08 |
0.21 |
0.09 |
Aliquot 2 OD |
2.03 |
0.23 |
0.08 |
|
Tissue 3 |
Aliquot 1 OD |
1.95 |
0.02 |
0.10 |
Aliquot 2 OD |
2.04 |
0.03 |
0.10 |
|
All tissues |
Average OD |
2.08 |
0.12 |
0.11 |
Average % Viability |
100.00 |
5.75 |
5.37 |
|
Average % SD |
4.01 |
3.76 |
1.18 |
|
Average % CV |
4.01 |
65.52* |
22.06 |
NC: negative control (H2O), PC: Positive control (KOH 8N), TA1: Octanoic Acid Triethanolamine Salt. *CV value of the PC is above 30% (65.52%) however, as the percentage of viability is below 20% (5.75%) acceptance criterion 3 is met (as per OECD TG431).
Evalutation of the results - Results were checked against the following acceptance criteria:
|
|
Actual values |
Pass/Fail |
||||||||||||
Acceptance criterion 1 |
The mean OD570of the negative control tissues must be ≥0.8.
|
3 min = 2.41 1 hr = 2.08 |
Pass |
||||||||||||
Acceptance criterion 2 |
The mean relative percentage viability of the positive control, after 1hour exposure must be < 15% of the mean of the negative control.
|
5.75 |
Pass |
||||||||||||
Acceptance criterion 3 |
In the range between 20% and 100% viability, the coefficient of variation (CV) is an additional acceptance criterion.It should not exceed 0.3(30%).
|
|
Pass |
*Note that the CV values of the PC after 3 min and 1hr were above 30% (45.10% and 65.52% respectively). However, as the percentage of cell viability was below 20% (5.82% and 5.75% respectively), acceptance criterion 3 was met (as per OECD TG431).
Results Summary
Test item |
Test Item ID |
Viability after (% to negative control) |
Viability ≥ 50% after 3 minutes (Yes/No) |
Viability after 1h application (% to negative control) |
Viability ≥ 15% after 1 hour (Yes/No) |
Corrosive (C) / Non corrosive |
Octanoic Acid Triethanolamine Salt |
TA1 |
84.23 |
Yes |
5.37 |
No |
Corrosive |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- After a 3 minute and 1 hour exposure on the surface of EpiDermTM reconstructed human epidermis, the viability of the tissues was assessed and compared to a negative control. The percentage viabilities obtained after 3 minutes and 1hr were 84.23% and 5.37% respectively and therefore Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) is classified as Corrosive to human skin, and can be sub-categorised as 1B/1C.
- Executive summary:
The skin corrosion potential of Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) was assessed in vitro according to OECD Test Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method). This study was conducted in accordance with GLP and assigned a Klimisch score of 1 using the criteria for assessing data quality set forth by Klimisch et al. (1997)
This in vitro assay predicts the skin corrosion potential of a chemical by measurement of its cytotoxic effect on the EpiDerm™ tissue model. The test item is applied directly to the skin surface, cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from the skin tissues.
Prior to the execution of the study, the required compatibility checks confirmed that the test item did not interfere with MTT, and following the study results were checked and validated against acceptance criteria.
A test item is classified "corrosive", if the relative mean of tissue viability after 3 minute treatment with a test material is decreased below 50%. In addition, those materials classified "non-corrosive" after 3 minute treatment (viability ≥ 50%) are classified "corrosive" if the relative mean of tissue viability after 1 hour treatment with a test material is decreased below 15%.
The classification can be then further sub-categorized to 1 A or B/ C. A test item is classified "corrosive, optional Sub-Category 1A", if the relative tissue viability after 3 minute treatment with a test material is decreased below 25%. A test item is classified "corrosive, optional Sub-Category 1B/1C", if the relative tissue viability after 3 minute treatment with a test material is ≥25%.
In this study, the percentage viabilities obtained after 3 minutes and 1hr were 84.23% and 5.37% respectively therefore Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) is classified as Corrosive to human skin, and can be sub-categorised as 1B/1C.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.