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EC number: 205-755-1 | CAS number: 150-25-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 December 2016 - 17 January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability 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:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)glycine
- EC Number:
- 205-755-1
- EC Name:
- N,N-bis(2-hydroxyethyl)glycine
- Cas Number:
- 150-25-4
- Molecular formula:
- C6H13NO4
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)glycine
- Reference substance name:
- N-(2-hydroxyethyl)ethylenediaminetriacetic acid
- EC Number:
- 205-759-3
- EC Name:
- N-(2-hydroxyethyl)ethylenediaminetriacetic acid
- Cas Number:
- 150-39-0
- Molecular formula:
- C10H18N2O7
- IUPAC Name:
- N-{2-[bis(carboxymethyl)amino]ethyl}-N-(2-hydroxyethyl)glycine
- Reference substance name:
- Not specified
- IUPAC Name:
- Not specified
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- solid: crystalline
- Details on test material:
- Appearance: white crystalline powder
Storage conditions: at room temperature protected from light
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- Stability at higher temperatures: stable, maximum temperature: 40 °C, maximum duration: 2 days
pH: 4-5 (10% solution)
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µl of a 20% (w/v) solution of test substance prepared in physiological saline per cornea
NEGATIVE CONTROL
- Amount applied: 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount applied: 750 µl 20% (w/v) Imidazole solution prepared in physiological saline - Duration of treatment / exposure:
- 240 ± 10 minutes
- Number of animals or in vitro replicates:
- Test item: 3
Negative control: 3
Positive control: 3 - Details on study design:
- TEST SITE
- Isolated bovine cornea, obtained from the slaughterhouse, where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
REMOVAL OF TEST SUBSTANCE
- Washing: yes, three times with MEM with phenol red (Eagle’s Minimum Essential Medium, Life Technologies)
- Time after start of exposure: 240 minutes
SCORING SYSTEM:
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score: In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter (OP-KIT) and microplate reader (TECAN Infinite® M200 Pro Plate Reader).
DATA EVALUATION:
A test substance that induces an IVIS = 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: catgegory 1);
For a test substance that induces an IVIS >3 and = 55, no prediction on irritant potency can be made.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean of 3 replicates
- Run / experiment:
- 1st experiment
- Value:
- 3.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (2.4)
- Positive controls validity:
- valid
- Remarks:
- (159.7)
- Remarks on result:
- other: Individual scores were spread over 2 categories
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean of 3 replicates
- Run / experiment:
- 2nd experiment
- Value:
- 3.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.2)
- Positive controls validity:
- valid
- Remarks:
- (129.9)
- Remarks on result:
- other: Individual scores were spread over 2 categories
- Other effects / acceptance of results:
- - In the first experiment the individual IVIS for the negative controls were 2.0-2.8. The 3 cornea were slightly translucent but since all opacity and permeability values were within the historical data control range this had no effect on the study. Individual IVIS of the positive control were 143-184, the corneas were turbid after 240 minutes of treatment. The corneas treated with test item showed opacity scores of 1.6-6.4 and permeability values of -0.030 - 0.061. The corneas were clear after 240 minutes of treatment. A pH effect of the test item was observed on the rinsing medium. Therefore the corneas were rinsed until no colour change of the medium was observed. Hence, the IVIS ranged from 1.3-5.9 after 240 minutes of treatment. Because the individual IVIS were spread over 2 categories, the test was inconclusive and a second experiment was performed.
- In the second experiment the individual IVIS for the negative controls were -0.6-0.9 and for the positive control 106-175. The corneas treated with the positive control were turbid after 240 minutes of treatment. The corneas treated with test item showed opacity values of 1.0-5.0 and permeability values of 0.000-0.013. The corneas were slightly translucent after the 240 minutes of treatment. In addition, two corneas showed a spot. a pH effect of the test item was observed. Hence, the IVIS ranged from 1.2 to 5.2 after 240 minutes if treatment. Since individual IVIS were spread over 2 categories, the test was inconslusive.
- Proper functioning of the test system in both experiments was shown by the results from the positive and negative controls, which were within the historical data range. Therefore, the acceptability criteria were met and the test was considered to be valid.
- Since both experiments provided inconclusive results, no conclusion can be drawn for eye irritation or serious eye damage.
Any other information on results incl. tables
Table 1 First experiment: Summary of opacity, permeability and in vitro scores
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score1, 2 |
Negative control |
1.8 |
0.037 |
2.4 |
Positive control |
135.9 |
1.588 |
159.7 |
Bicin |
3.2 |
0.001 |
3.3 |
1Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
2In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Table 2 Second experiment: Summary of opacity, permeability and in vitro scores
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score1, 2 |
Negative control |
0.1 |
0.004 |
0.2 |
Positive control |
109.3 |
1.379 |
129.9 |
Bicin |
3.2 |
0.009 |
3.4 |
1Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
2In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Applicant's summary and conclusion
- Interpretation of results:
- other: Results were spread in two categories and were therefore inconclusive.
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline and GLP principles, no conclusion can be drawn for eye irritation of the substance. The mean IVIS in two experiments were 3.3 and 3.4, but individual scores were spread over two categories.
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