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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 263-179-6 | CAS number: 61791-46-6
- 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:
- weight of evidence
- Study period:
- April - May, 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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- EC Number:
- 263-179-6
- EC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Cas Number:
- 61791-46-6
- Molecular formula:
- n.a
- IUPAC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: poultry slaughterhouse
- Number of animals: 7
- Characteristics of donor animals: 6 to 7 weeks old and weighing around 1.5 to 2.5 kg
- Storage, temperature and transport conditions of ocular tissue. Heads were removed immediately after sedation of the chickens, by electric shock and incision of the neck for bleeding. The intact heads were transported from the slaughterhouse at ambient temperature (typically between 18 °C and 25 °C) in plastic boxes humidified with tissues moistened with isotonic saline.
- Time interval prior to initiating testing: The procedure involving the collection of chicken heads and placing the eyes in the superfusion chamber following enucleation was completed within two hours to minimize deterioration and/or bacterial contamination.
- indication of any existing defects or lesions in ocular tissue samples: The eyelids of chicken heads were carefully excised, without damaging the cornea. Corneal integrity was quickly assessed with a drop of 2% (w/v) sodium fluorescein applied to the corneal surface for few seconds and then rinsed with isotonic saline. Fluorescein – treated eyes were then examined with a slit-lamp microscope to ensure that the cornea is undamaged (i.e., fluorescein retention and corneal opacity scores ≤ 0.5).
- Indication of any antibiotics used: not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 mg - Duration of treatment / exposure:
- 10 s
- Duration of post- treatment incubation (in vitro):
- 30, 75, 120, 180 and 240 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
The eyelids of chicken heads were carefully excised, without damaging the cornea. Corneal integrity was quickly assessed with drop a of 2% (w/v) sodium fluorescein applied to the corneal surface for few seconds and then rinsed with isotonic saline. Fluorescein – treated eyes were then examined with a slit-lamp microscope to ensure that the cornea is undamaged (i.e., fluorescein retention and corneal opacity scores ≤ 0.5).
EQUILIBRATION AND BASELINE RECORDINGS
After confirming that the eyes were undamaged, the eyes were further dissected from the skull, taking care not to damage the cornea. The eyeball was pulled from the orbit by holding the nictitating membrane firmly with surgical forceps, and the eye muscles was cut with a bent, blunt-tipped scissor. All necessary precautions were taken to avoid any corneal damage due to excessive pressure (i.e, compression artifacts). The visible portion of the optic nerve was left attached to the eye when it was removed from the orbit. Immediately after removing the eye from the orbit, the eye was placed on an absorbent pad and the nictitating membrane and other connective tissue were removed. The enucleated eye was mounted in a stainless steel clamp with the cornea positioned vertically. The clamp was then transferred to a chamber of the superfusion apparatus. The entire cornea was supplied with the isotonic saline drip (3 to 4 drops per minute or 0.1 to 0.15 mL/min) by positioning the clamps in the superfusion apparatus. The temperature of the chambers of the superfusion apparatus was maintained at 32 ± 1.5 °C. After being placed in the superfusion apparatus, the eyes were again examined with a slitp-lamp microscope to ensure that there were no damage during the dissection procedure. Corneal thickness was measured at this time using the depth measuring device (Pachymeter). Eyes with (i), a fluorescein retention score of >0.5, (ii) corneal opacity >0.5 or (iii) any additional signs of damage were not selected for the study.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL (NC) USED
Yes, sodium chloride (0.9 % w/v)
POSITIVE CONTROL (PC) USED
Yes, imidazole
APPLICATION DOSE AND EXPOSURE TIME
Test item: 30 mg, 10 s
PC: 30 mg, 10 s
NC: 30 µL, 10s
OBSERVATION PERIOD
30, 75, 120, 180 and 240 minutes
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: isotonic saline (approximately 20 mL) at ambient temperature.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was evaluated by using the area of the cornea that was most densely opacified for scoring. The mean corneal opacity value for all test eyes was calculated for all observation time points. Based on the highest mean score for corneal opacity, as observed at any time point, an overall category score was provided for test item, negative control and positive control group.
- Damage to epithelium based on fluorescein retention: Fluorescein retention was evaluated at the 30 minute observation time point only. The mean fluorescein retention value of all test eyes was calculated for the 30 minute observation time point and used for the overall category score given for test item.
- Swelling: measured with optical pachymeter on a slit-lamp microscope; slit-width setting: Corneal swelling was determined from corneal thickness measurements made with a pachymeter and was expressed as a percentage and is calculated from corneal thickness measurements according to the following formula:
[(Corneal thickness at time t – Corneal thickness at time t = 0) / Corneal thickness at time t = 0] ×100
The mean percentage of corneal swelling for all test eyes was calculated for all observation time points. Based on the highest mean score for corneal swelling, as observed at any time point, an overall category score was provided for test item, negative and positive control group.
- Macroscopic morphological damage to the surface: Post treatment, the control and test eyes were evaluated for morphological effects, if any such as “pitting” of corneal epithelial cells, “loosening” of epithelium, “roughening” of the corneal surface and “sticking” of the test item to the cornea. The morphological effects were evaluated and recorded individually for all the eyes.
SCORING SYSTEM:
- Mean corneal swelling (%)
- Mean maximum opacity score
- Mean fluorescein retention score at 30 minutes post-treatment
DECISION CRITERIA: The decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Value:
- <= 5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- fluorescein retention score
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Any other information on results incl. tables
Table 7: Data of corneal sweling/thickness and ICE classification
Treatment |
Eye No. and Sw% |
Corneal Thickness (µm) at t (minutes) |
|||||||
Selection |
0 |
30 |
75 |
120 |
180 |
240 |
ICE Class |
||
Negative Control |
1 |
306 |
303 |
288 |
301 |
304 |
298 |
280 |
I |
Sw% |
NA |
NA |
-4.95 |
-0.66 |
0.33 |
-1.65 |
-7.59 |
||
Positive control |
2 |
309 |
297 |
383 |
464 |
487 |
481 |
550 |
IV |
Sw% |
NA |
NA |
28.96 |
56.23 |
63.97 |
61.95 |
85.19 |
||
3 |
306 |
302 |
377 |
461 |
467 |
486 |
546 |
||
Sw% |
NA |
NA |
24.83 |
52.65 |
54.64 |
60.93 |
80.79 |
||
4 |
305 |
301 |
384 |
468 |
488 |
482 |
544 |
||
Sw% |
NA |
NA |
27.57 |
55.48 |
62.13 |
60.13 |
80.73 |
||
Mean sw% ±SD |
NA |
NA |
27.12 2.10 |
54.79 1.89 |
60.25 4.94 |
61.00 0.91 |
82.24 2.55 |
||
Test Item (Trial 1) |
5 |
302 |
294 |
288 |
297 |
301 |
292 |
299 |
I |
Sw% |
NA |
NA |
-2.04 |
1.02 |
2.38 |
-0.68 |
1.70 |
||
6 |
298 |
300 |
285 |
299 |
290 |
294 |
297 |
||
Sw% |
NA |
NA |
-5.00 |
-0.33 |
-3.33 |
-2.00 |
-1.00 |
||
7 |
298 |
307 |
298 |
285 |
286 |
290 |
284 |
||
Sw% |
NA |
NA |
-2.93 |
-7.17 |
-6.84 |
-5.54 |
-7.49 |
||
|
Mean Sw% ±SD |
NA |
NA |
-3.32 1.52 |
-2.16 4.39 |
-2.60 4.65 |
-2.74 2.51 |
-2.26 4.72 |
|
Test Item (Trial 2) |
1 |
302 |
281 |
286 |
286 |
282 |
285 |
292 |
I |
Sw% |
NA |
NA |
1.78 |
1.78 |
0.36 |
1.42 |
3.91 |
||
2 |
276 |
286 |
295 |
292 |
295 |
288 |
285 |
||
Sw% |
NA |
NA |
3.15 |
2.10 |
3.15 |
0.70 |
-0.35 |
||
3 |
279 |
281 |
287 |
287 |
292 |
281 |
286 |
||
Sw% |
NA |
NA |
2.14 |
2.14 |
3.91 |
0.00 |
1.78 |
||
Mean Sw% ±SD |
NA |
NA |
2.35 0.71 |
2.00 0.20 |
2.47 1.87 |
0.71 0.71 |
1.78 2.13 |
||
Sw%: Corneal Swelling percentage, SD: Standard deviation, t: time. |
Table 8: Data of corneal opacity and ICE classification
Treatment |
Eye No. |
Corneal Opacity Scores at t (Minutes) |
|||||||
Selection |
0 |
30 |
75 |
120 |
180 |
240 |
ICE Class |
||
Negative Control |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
I |
Positive Control |
2 |
0 |
0 |
2 |
3 |
4 |
4 |
4 |
IV |
3 |
0 |
0 |
2 |
3 |
4 |
4 |
4 |
||
4 |
0 |
0 |
2 |
2 |
4 |
4 |
4 |
||
Mean |
0 |
0.0 |
2.0 |
2.7 |
4.0 |
4.0 |
4.0 |
||
Test Item (Trial 1) |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
I |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Mean |
0 |
0.0 |
0 |
0.0 |
0 |
0.0 |
0 |
||
Test Item (Trial 2) |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
I |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Mean |
0 |
0.0 |
0 |
0.0 |
0 |
0.0 |
0 |
Table 9: Data of fluorescein retention, morphological effects and ICE classification
Groups |
Eye No. |
Fluorescein retention at t = (Minutes) |
Morphological effects |
ICE Class |
||
Selection |
0 |
30 |
||||
Negative Control |
1 |
0 |
0 |
0 |
No morphological effects observed |
I |
Positive Control |
2 |
0 |
0 |
1 |
Loosening of epithelium |
III |
3 |
0 |
0 |
1 |
Loosening of epithelium |
||
4 |
0 |
0 |
1 |
Loosening of epithelium |
||
Mean |
0.0 |
0.0 |
1.0 |
NA |
||
Test Item (Trial 1) |
5 |
0 |
0 |
0 |
No morphological effects observed |
I |
6 |
0 |
0 |
0 |
No morphological effects observed |
||
7 |
0 |
0 |
0 |
No morphological effects observed |
||
Mean ±SD |
0.0 |
0.0 |
0.0 |
NA |
||
Test Item (Trial 2) |
1 |
0 |
0 |
0 |
No morphological effects observed |
I |
2 |
0 |
0 |
0 |
No morphological effects observed |
||
3 |
0 |
0 |
0 |
No morphological effects observed |
||
|
Mean ±SD |
0.0 |
0.0 |
0.0 |
NA |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an ex vivo chicken eye irritation/corrosion assay according to OECD guideline 438, evaluation of the test item resulted in an ICE category classification of 3x I. Thus, the test item does not show eye damaging properties.
- Executive summary:
The test item was evaluated in the “Isolated Chicken eye test method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage” as per OECD Guideline 438. Heads of chickens approximately 6 to 7 weeks old and weighing around 1.5 to 2.5 kg were collected at poultry slaughterhouse. Within 2 hours after killing, enucleated eyes were placed in a susperfusion apparatus. Before dosing, the eyes were incubated for 60 minutes at 32 ± 1.5 °C to equilibrate them to the test system prior to treatment. Following the equilibration period, a zero reference measurement was recorded for corneal thickness and opacity to serve as baseline (i.e., time = 0). Additionally, the fluorescein retention score was also recorded at 0 hour as baseline measurement value. Eyes with corneal opacity <0.5 and fluorescein retention score <0.5 were selected. 30 mg of test item and 30 mg imidazole was applied onto the cornea of three eyes for 10 seconds. Similarly, 30 µL of Sodium Chloride injection IP, 0.9 % w/v was used as negative control and was applied onto the cornea of each eye for 10 seconds. The control and test eyes were examined for corneal thickness and corneal opacity at 0, 30, 75, 120, 180 and 240 min after treatment and results were recorded according to a fixed scoring system. Fluorescein retention by damaged epithelial cells was scored at 30 min post-treatment. Additionally, the eyes were evaluated for morphological effects. All examinations were carried out with a slit-lamp microscope and Pachymeter.
The in vitro classification for a test item was assessed by reading the GHS classification that corresponds to the combination of categories obtained for corneal swelling, corneal opacity and fluorescein retention. The combination of ICE categories obtained for corneal swelling, corneal opacity, and fluorescein retention was 3 x I (ICE class of I observed in all 3 endpoints). This test is considered acceptable as the concurrent negative control and the positive control were identified as GHS Non-Classified and GHS Category 1, respectively.
Based on the percentage of corneal swelling, corneal opacity score, fluorescein retention score and morphological effects obtained under the laboratory testing conditions and on the basis of overall combination of ICE categories obtained for all three end points, the test item was identified for classification as UN GHS No Category.
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.