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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 620-539-0 | CAS number: 1218787-30-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 22 June 2010 and 25 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The protocol followed was considered to be a reliable alternative to the in vivo rabbit Draize eye irritation test in a pre-validation study. This study, using human derived keratinocytes which form a corneal epithelial tissue reconstruct, has been recommended by ECVAM for inclusion in a formal international validation study designed to offer a stand alone replacement to the in vivo test. Validation is expected to commence in 2010.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 15-09-2009 Date of Signature: 26-11-2009
Test material
- Reference substance name:
- 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC Number:
- 620-539-0
- Cas Number:
- 1218787-30-4
- Molecular formula:
- No molecular formula
- IUPAC Name:
- 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- Test material form:
- other: liquid/paste
- Details on test material:
- - Chemical name: 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC number: 620-539-0
To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.
Constituent 1
Test animals / tissue source
- Species:
- other: Reconstructed Human Corneal Model
- Strain:
- other: Reconstructed Human Corneal Model
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- other: No vehicle used
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
-The test Material was applied neat.
-Amounts(s) applied (volume or weight with unit):
Triplicate tissues were treated with 30 mg of the test material. To improve test material tissue contact 30 µl of PBS was applied to the tissue surface and aspirated prior to the application of the test material.
-Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used. - Duration of treatment / exposure:
- 60 Minutes and 16 post exposure incubation.
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- TEST SITE
-Area of exposure:
Triplicate tissues were treated with 30 mg of the test material for an exposure period of 60 minutes. To improve test material tissue contact 30 µl of PBS was applied to the tissue surface and aspirated prior to the application of the test material.
-% coverage:
The test material was applied topically to ensure uniform covering of the tissues.
-Type of wrap used:
None used.
REMOVAL OF TEST SUBSTANCE
-Washing (if done):
At the end of the exposure period, each tissue insert was removed from the well using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) without Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert at least ten times using a constant stream of PBS.
-Time after start of exposure:
60 Minutes post exposure.
SCORING SYSTEM:
The relative mean tissue viability (percentage of the negative control) was calculated as follows:
The mean tissue viability for the test material was compared to the respective untreated negative control and classified according to the following:
Tissue viability ≤ 50 = Irritant
Tissue viability > 50 = Non-Irritant
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Viability of tissue %
- Value:
- 50.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
RESULTS
Assessment of Direct Test Material Reduction of MTT
An assessment found the test material was able to directly reduce MTT. Therefore, an additional procedure using freeze-killed tissues was performed during the determination of ocular irritation potential. However the results obtained showed that no degree of interference due to direct reduction of MTT occurred indicating the test material was adequately rinsed from the tissues. 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 Eye Irritation Potential
The mean OD540 values and the relative mean tissue viability of the test material, and negative and positive control treatment groups are given in Table 1.
The relative mean viability of the test material treated tissues after the 60 -Minute exposure period and a 16-Hour post exposure incubation period was 50.2
Qualitative Evaluation of Tissue Viability (MTT Uptake Visual Assessment)
The qualitative evaluation of tissue viability is presented in Table 2.
The test material treated tissues appeared blue/white which was considered to be indicative of semi-viable tissue. The negative control material treated tissues appeared blue which was considered to be indicative of viable tissue and the positive control material treated tissues appeared white which was considered to be indicative of dead tissue.Assay Acceptance Criterion
The quality criterion required for the acceptance of results in the test was satisfied.Table 1 Assessment of Eye Irritation Potential – Viability of RHC Tissues
Material |
Mean Tissue Viability |
Mean OD 540 |
Viability (%) |
Negative Control |
0.917 |
0.934 |
100* |
0.944 |
|||
0.942 |
|||
Positive Control |
0.028 |
0.023 |
2.5 |
0.020 |
|||
0.022 |
|||
Test Material |
0.457 |
0.469 |
50.2 |
0.507 |
|||
0.442 |
*= The mean viability of the negative control tissues is set at 100%
Table 2 Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Score |
||
Tissue 1 |
Tissue 2 |
Tissue 2 |
|
Negative Control |
- |
- |
- |
Positive Control |
++ |
++ |
++ |
Test Material |
+ |
+ |
+ |
MTT Visual Scoring Scheme of SkinEthic Tissues
- = Blue tissue (viable)
+ = Blue/White tissue (semi viable)
++ = Tissue completely white (dead)
Applicant's summary and conclusion
- Conclusions:
- According to the protocol followed the test material was considered to be a Non-Irritant (NI). However the viability of 50.2 is extremely close to the classification cut off of 50% for eye irritation and the in-vitro skin irritation the data indicates less sensitivity for this chemistry than in-vivo. Therefore Ethanol, 2,2’-iminobis-,N-(hydrogenated tallow alkyl) derivs. CAS No 90367-28-5 (registered as 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4) will be classified as EU CLP(GHS) Category 2 for eye irritation with Hazard statement H319 Causes serious eye irritation.
- Executive summary:
Introduction.
The purpose of this study was to determine the eye irritation potential of the test material, using the SkinEthic Reconstituted Human Corneal Epithelial (HCE) model. The principle of the assay is based on the measurement of cytotoxicity in reconstituted human corneal epithelium cultures after topical exposure to the test material by means of the colourimetric MTT reduction assay.
The endpoint, cytotoxicity in the MTT assay, expressed as percent viability of treated cultures in comparison to negative controls, was evaluated.
The test material was classified based on MTT viability analysis according to the following prediction model after a 60-Minute exposure period and 16-Hour post exposure incubation period:
i) The test material was considered to be non-irritant to the eye if the tissue viability was >50%
ii) The test material was considered to be irritant to the eye if the tissue viability was ≤50%.Results.
The relative mean viability of the test material treated tissues after the 60‑Minute exposure period and a 16‑Hour post exposure incubation period was 50.2%.
Conclusion. According to the protocol followed the test material was considered to be a Non-Irritant (NI).
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)