Registration Dossier
Registration Dossier
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: 309-811-7 | CAS number: 101033-44-7
- 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

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017 July to 2017 September
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Supplier: Borica Co., Ltd.
- Lot number: 110422Y
- Expiration date of the lot/batch: 2017-Dec-12
- CAS number: 101033-44-7 - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm (EPI-200-MatTek Corporation) was used as reconstructed human epidermal model. It consisted of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consisted of organized 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.
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) RECONSTRUCTED HUMAN EPIDERMIS
- Tissue batch number(s): 25837
- Date of initiation of testing: 2017-Jul-13
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.] - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 microliter neat test material
VEHICLE
- Not used
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter Sterile Dulbecco's phosphate buffered saline (DPBS)
- Concentration (if solution): neat
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter Sodium dodecyl sulphate (SDS)
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 60 +/- 1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, >=95% RH)
- Duration of post-treatment incubation (if applicable):
- 42 +/- 4 h hours post-treatment incubation.
- Number of replicates:
- 3 repliecate per run.
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- ca. 90.85
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A test item is considered to be an irritant (I) to skin in accordance with UN GHS Category 2 or EU R38 if the skin model viability after exposure and post-treatment incubation is ≤50%.
A test item may be considered as a non-irritant (NI) if the skin model viability after exposure and post-treatment incubation is > 50%.
The percentage of viability obtained with the test item Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium was 90.85%, therefore it was considered as non-irritant to the skin. - Executive summary:
The skin irritation potential of Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium was assessed in vitro according to OECD Test Guideline 439: In Vitro Skin irritation: Reconstructed Human Epidermis Test Method.
After 60 +/- 1 min exposure on the surface of the EpiDerm™ reconstructed human epidermis and a 42 +/- 4 h post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 90.85% and therefore the target substance was classified as non-irritant to the skin.
Reference
Table 3. Mean and SD of cell viability measurements and of viability precentages after 60 min (+/- 1 min) of application and 42 h (+/-4 h) post-incubation.
Name | Code | Mean of OD | SD of OD | Mean of viability (%) | SD of viability (%) | CV (%) | Classification |
DPBS | NC | 1.322 | 0.150 | 100.0 | 11.34 | 11.34 | Non-irritant |
SDS 5% | PC | 0.054 | 0.014 | 4.085 | 1.07 | 26.26 | Irritant |
Test item | TA3 | 01.201 | 0.086 | 90.847 | 6.50 | 7.15 | Non-irritant |
Predition model: test items that reduce the viability to 50% or below are irritant (I); test items with a percentage viability above 50% are considered to be non-irritant (NI).
Notes:
NC: Negative control
PC: Positive control
TA3: Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017 July to 2017 September
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Supplier: Borica Co., Ltd.
- Lot number: 110422Y
- Expiration date of the lot/batch: 2017-Dec-12
- CAS number: 101033-44-7 - Species:
- human
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 microliter
- Concentration (if solution): neat
VEHICLE
- Not used - Duration of treatment / exposure:
- 30 minutes +/- 2 min
- Duration of post- treatment incubation (in vitro):
- 12 +/- 2 min post-treatment immersion and 2 hours +/- 15 min post-treatment incubation.
- Number of animals or in vitro replicates:
- 3 replicates per run.
- Details on study design:
- - Details of the test procedure used
Prior to the study, the required compatibility checks confirmed that the test item interfered with MTT and therefore additional freeze killed negative controls (NC-FK) and freeze killed test item controls (TA-FK) were included in the assay to determine the background level of interference (manifesting as altered viability) produced by the test item. The level of viability measured in the interference controls was subtracted from the standard test viability value to give an adjusted final viability. No water colouration was observed and therefore colorant control was not required.
After pre-wetting tissues with 20 microliter PBS (Sterile Dulbecco’s phosphate buffered saline) for 30 +/- 2 min, single topical application of 50 microliter of neat test item or of reference items to the surface of the EpiOcular™ models for 30 +/- 2 min, followed by a 12 +/- 2 min post-treatment immersion, and 2 hr +/- 15 min post-treatment incubation, prior to the MTT endpoint; three tissues per condition (n = 3).
- RhCE tissue construct used, including batch number
EpiOcular™ EIT (OCL-200) Reconstructed Human Ocular Epithelium
Supplier: MatTek Corporation
Keratinocyte Strain: 4F1188
Lot number: 23799
Description of the RhCE tissue: The EpiOcular™ tissue model (OCL200-MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo.
- MTT test conditions
Spectrometer: BMG LabTech FluoStar Optima
Wavelength for O.D. measurements: 570 nm
- Positive and negative control means and acceptance ranges based on historical data
1. Mean OD570 of the negative control (treated with sterile water) tissues is > 0.8 and < 2.5.
2. Mean of the positive control relative percentage viability is below 50% of negative control viability after 30 +/- 2 minutes exposure.
- Acceptable variability between tissue replicates for positive, negative controls and test items
The SD between three tissues replicates should not exceed 18% in the same run (for negative and positive control tissues and tissues of test items). - Irritation parameter:
- other: Tissue viability
- Run / experiment:
- 1 run, 3 replicates per run
- Value:
- ca. 72.62
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A Test item is considered to be irritant to the eye (i.e. would require labelling as either GHS 1 or 2) if they eye model viability after exposure and post-treatment incubation is ≤ 60%.
A test item is considered as a non-irritant to the eye (i.e. would not require a warning label in the European chemical classification systems) if the eye model viability after exposure and post-treatment incubation is > 60%.
The current assay is not intended to differentiate between GHS class 1 and GHS class 2 or R36 and R41 (degree of stromal damage).
The percentage of viability obtained with test item target substance was 72.62%, therefore it is considered as Non-Irritant to the eye. - Executive summary:
The eye irritation potential of Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium 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 labeling for eye irritation or serious eye damage).
After a 30 +/-2 minute exposure on the surface of EpiOcular™ reconstructed ocular epithelium and 2 h +/- 15 mins post-incubation time, the viability of the tissues was assessed and compared to a negative control. The percentage viability was 72.62 % and therefore the target substance was classified as Non-Irritant to the human eye.
Reference
Table 3. Mean and SD of viability measurements and of viability percentages after 30 +/- 2 min of application and 2 h +/- 15 min post-incubation of test and reference items.
Consition | Mean of OD | SD of OD | mean of viability % | SD of viability (%) | CV % | Classification |
NC | 1.657 | 0.016 | 100.00 | 0.938 | 0.938 | Non-irritant |
PC | 0.522 | 0.115 | 31.479 | 6.964 | 22.122 | Irritant |
TA | 1.204 | 0.233 | 72.624 | 14.058 | 19.358 | Non-irritant |
Note:
NC: Negative control (sterile H2O)
PC: neat methyl acetate
TA: Tetrakis[[2,2',2''-nitrilotris[ethanolato]](1 -)-N,O]zirconium
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin and eye irritation tests have been conducted on the target substance using alternative in vitro methods – OECD 439, reconstructed human epidermis, and OECD 492, reconstructed human cornea-like epithelium. The target substance was found non-irritating in the two tests.
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products –2,2',2''-Nitrilotriethanol (triethanolamine, TEA).
Triethanolamine is not irritating to skin and eyes. A group of 64 humans was tested with 1% TEA (vehicle unknown). Testing was conducted by 24-hour semi-occlusive patches to the upper arm 3 times per week for 3 weeks. Fourteen days later challenge patches were applied to the opposite arm. During the induction period, signs of irritation ranged from "moderate" (on anly a very small number of occasions) to mild or no irritation (approximately evenly distributed between these two). At challenge, 14 days later (graded at 48 and 96 hours) there were some signs of mild irritation, but overall no evidence of sensitisation. Some other reports of skin sensitisation amongst humans exist, albeit at a low incidence amongst the populations studied. However, due to poor reporting it remains unclear whether or not these reports are in fact skin irritation rather than sensitisation. (OECD SIDS 1995).
Based on above findings, the target substance is therefore considered not irritating to skin and eyes, according to CLP regulations. In addition, the two in vitro studies serve as evidence that the toxicological properties of the target substance closed related to the hydrolysis products.
Justification for classification or non-classification
Based on results of alternative in vitro methods, OECD 439 and OECD 492, tested on the target substance, the results indicated non-irritating to skin and eyes.
The hydrolysis product, triethanolamine, have also been found non-irritating to skin and eyes. Therefore, the target substance was classified as non-irritant to skin and eyes according to CLP regulation.
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.
