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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- April 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This is an OECD 492 guideline study conducted in accordance with GLP using substance Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1).
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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- 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
Test animals / tissue source
- Species:
- human
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- After pre-wetting tissues with 20µl PBS (sterile Dulbecco’s Phosphate Buffered Saline) for 30 minutes ± 2 minutes, a single, topical application of 50µl of neat test item or of reference items was applied to the surface of the EpiOcular(TM) models for 30 minutes ± 2 minutes.
- Duration of treatment / exposure:
- 30 minutes ± 2 minutes
- Duration of post- treatment incubation (in vitro):
- 12 minutes ± 2 minutes post-treatment immersion, and 2 hours ± 15 minutes post-treatment incubation, prior to the MTT endpoint
- Number of animals or in vitro replicates:
- Three tissues per condition (n=3).
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % Tissue Viability
- Run / experiment:
- 1
- Value:
- ca. 5.537
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No predication can be made as the viability was below 60%.
Any other information on results incl. tables
Results Summary
Test Item |
Percentage of viability
|
Classification (No category/No prediction) |
Octanoic Acid Triethanolamine Salt |
5.537%
|
No Prediction |
Viability measurements after 30 minutes (± 2 minutes) of application and 2 hours (± 15 minutes) post-incubation of test and reference items.
Condition |
Tissue # |
Raw Data |
Blank Corrected Data |
Mean OD |
% Viability |
||
Aliquot 1 |
Aliquot 2 |
Aliquot 1 |
Aliquot 2 |
||||
NC |
Tissue 1 |
1.933 |
1.937 |
1.778 |
1.782 |
1.780 |
98.234 |
Tissue 2 |
1.843 |
1.864 |
1.688 |
1.709 |
1.699 |
93.736 |
|
Tissue 3 |
2.106 |
2.119 |
1.951 |
1.964 |
1.958 |
108.030 |
|
PC |
Tissue 1 |
0.973 |
0.94 |
0.818 |
0.785 |
0.802 |
44.233 |
Tissue 2 |
0.848 |
0.852 |
0.693 |
0.697 |
0.695 |
38.355 |
|
Tissue 3 |
0.806 |
0.798 |
0.651 |
0.643 |
0.647 |
35.706 |
|
TA1 |
Tissue 1 |
0.293 |
0.279 |
0.138 |
0.124 |
0.131 |
7.230 |
Tissue 2 |
0.261 |
0.259 |
0.106 |
0.104 |
0.105 |
5.795 |
|
Tissue 3 |
0.222 |
0.218 |
0.067 |
0.063 |
0.065 |
3.587 |
Mean and SD of viability measurements and of viability percentages after 30 minutes (± 2 minutes) of application and 2 hours (± 15 minutes) post-incubation.
Name |
Code |
Mean of OD |
SD of OD |
Mean of viability |
SD of viability (%) |
CV % |
Classification |
Sterile water |
NC |
1.812 |
0.132 |
100.000 |
7.31 |
7.309 |
No-Category |
Methyl Acetate |
PC |
0.715 |
0.079 |
39.432 |
4.364 |
11.067 |
No Prediction |
Octanoic Acid Triethanolamine Salt |
TA1 |
0.100 |
0.033 |
5.537 |
1.835 |
33.136 |
No Prediction |
Evaluation of the Results - Results were checked against the following acceptance criteria.
|
Description |
Actual values |
PASS/FAIL |
Acceptance criterion 1 |
The mean OD570of the negative control(treated with sterile water) tissues is > 0.8 and < 2.5.
|
1.812 |
PASS |
Acceptance criterion 2 |
The mean of the positive control relative percentage viabilityis below 50% of negative control viability after 30 minutes± 2 minutes exposure. |
39.432% |
PASS |
Acceptance criterion 3 |
The SD of % viability between three tissue replicates should not exceed 18%in the same run (for negative and positive control tissues and tissues of test items). |
NC: 7.31% PC: 4.364% TA1: 1.835% |
PASS |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The percentage of viability obtained with test item Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) was 5.537%, therefore no prediction can be made.
- Executive summary:
The eye irritation potential of Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) was assessed in vitro according to OECD Test 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).
Prior to this study the required compatibility checks confirmed that the test item, Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) did not interfere with MTT, and following the study all results were checked and met the acceptance criteria.
· A test item is considered as “No Category”, i.e. not requiring a warning label in the European chemical classification systems for eye irritation or serious eye damage (UN GHS No Category), if the eye model viability after exposure and post-treatment incubation is >60%.
· If the mean percent tissue viability after exposure and post-exposure incubation is ≤60%, no prediction can be made.
After 30 ± 2 minutes exposure on the surface of EpiOcular™reconstructed ocular epithelium and 2 hours ± 15mins post-incubation time, the viability of the tissues was assessed and compared to a negative control.The percentage of viability obtained with test itemOctanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)was 5.537%, therefore no prediction can be made.
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