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EC number: 948-778-9 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trisodium (2S)-2,6-bis(3-carboxylatopropanamido)hexanoate
- EC Number:
- 948-778-9
- Molecular formula:
- C14O8H19N2Na3
- IUPAC Name:
- trisodium (2S)-2,6-bis(3-carboxylatopropanamido)hexanoate
- Test material form:
- liquid
- Details on test material:
- Active ingredient (%): 48.9% dry substance
Purity (%): 95.50 %
Stability: 5 years
Sterilization: None
Solubility: Soluble in water
Storage: Room Temperature
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 23ADB/50
- Expiration date of the lot/batch: 21/11/2023
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Justification for test system used:
- Method in compliance with current regulatory requirements
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM from MatTek Corporation (3D system of reconstructed epidermis of normal human keratinocytes)
- Tissue batch number(s): keratinocyte strain: 00267
- Production date: 16-01-2019
- Shipping date: n/a
- Delivery date: n/a
- Date of initiation of testing: 16-01-2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C
- Temperature of post-treatment incubation (if applicable): 37±1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of the exposure time the product and the controls were removed and the tissues rinsed for several times with DPBS (up to 25 times if necessary).
- Observable damage in the tissue due to washing: n/a
- Modifications to validated SOP: n/a
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT thiazolyl blue tetrazolium 5 mg/ml (MTT-100-CON) has been diluted with MTT diluent (MTT-100-DIL) up to 1 mg/ml.
- Incubation time: 3h
- Spectrophotometer: The absorbance is measured at 570 nm by microplate reader using a GEN5 software (Biotek).
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA
-The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%.
In case the test chemical is found to be non-corrosive (e.g., based on TG 430, 431 or 435), and shows tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%, the test chemical is considered to be irritant to skin in accordance with UN GHS Category 2.
Depending on the regulatory framework in member countries, the test chemical may be considered as non-irritant to skin in accordance with UN GHS No Category if the tissue viability after exposure and post-treatment incubation is more than (>) 50%.
According to EU classification, the irritancy potential of test substances is predicted to distinguish between H315 skin irritating (category 2) and not classified test substances (EU CLP).
In this study the irritancy potential of test substances is predicted by mean tissue viability of tissues exposed to the test substance.
The test substance is considered to be irritant to skin (H315), if the mean relative viability after 60 minutes exposure and 42 hours post incubation is less or equal to 50% of the negative control. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl
- Concentration (if solution): n/a applied neat
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): (H2O) 30 µl
- Concentration (if solution): n/a
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl
- Concentration (if solution):SDS 5% in DPBS - Duration of treatment / exposure:
- 25 min at room temperature
residual incubation time to 60 minutes has been done at 37±1°C, 5% CO2. - Duration of post-treatment incubation (if applicable):
- At the end of the exposure time the product and the controls were removed and the tissues rinsed for several times with DPBS (up to 25 times if necessary).
Each tissue was then transferred in 6-well plate with 1 ml of Assay Medium and incubated for 24±2 hours at 37±1°C, 5% CO2, then the tissues will be transfer in a renewed Assay Medium for 18±2 h at 37±1°C, 5% CO2 before the MTT test. - Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean value
- Value:
- 73.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
ACCEPTABILITY CRITERIA
Negative control: the mean OD570nm value of the negative control tissues should be ≥0.8 and ≤2.8.
Positive control: the mean viability value of positive control tissues, expressed as % against negative control tissues should be ≤20%.
Standard deviation (SD): the SD calculated from individual % tissue viabilities of the 3 treated replicates should be ≤18%.
Any other information on results incl. tables
RESULTS
Optical density (OD Value) at 570 nm.
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
||||||
Replicates |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Negative control |
2,283 |
2,307 |
2,283 |
2,386 |
2,339 |
2,346 |
2,480 |
2,460 |
2,471 |
Positive control |
0,111 |
0,110 |
0,111 |
0,127 |
0,127 |
0,128 |
0,119 |
0,116 |
0,117 |
Sample |
1,588 |
1,599 |
1,572 |
1,867 |
1,835 |
1,845 |
1,840 |
1,803 |
1,803 |
ASSAY VALIDITY CRITERIA |
Value |
Acceptability |
Result |
|
Negative control |
Mean OD value |
2.33 |
≥0.8 and≤2.8 |
Complies |
Positive control |
Mean Viability % |
3.28 |
≤ 20 |
Complies |
SD |
0.347 |
≤ 18 |
Complies |
|
Sample |
SD |
6.139 |
Complies |
SAMPLE |
% VIABILITY |
TRISODIUM (2S)-2,6-BIS(3- |
73.30 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the results, interpreted according to OECD 439 the test item “TRISODIUM (2S)-2,6-BIS(3-CARBOXYLATOPROPANAMIDO)HEXANOATE” must be considered NOT IRRITANT for the skin.
- Executive summary:
On the test item “TRISODIUM (2S)-2,6-BIS(3-CARBOXYLATOPROPANAMIDO)HEXANOATE” an in
vitro toxicological study aimed to evaluate any potential cutaneous irritation was carried out.
The following test was performed:
-In vitro skin irritation test on Reconstructed Human Epidermis according to OECD N. 439:2015.
To perform the in vitro skin irritation test, three-dimensional Reconstructed Human Epidermis (RHE) tissues, consisting of normal human keratinocytes cultured for 17-days on an inert 0.63 cm2polycarbonate filter at the air-liquid interface, were used.
The test item was topically applied on three tissues replicates for 60 minutes. Exposure was followed by rinsing with phosphate buffer saline (DPBS) and dried, then tissues were transferred to fresh medium and incubated for 42 additional hours, then tissues were transferred to MTT for 3 hours. The aim of this assay was to assess quantitatively the effects of the tested product on cell survival through the MTT assay.
Cell viability determination is based on cellular dehydrogenase activity, measured by MTT reduction and conversion into blue formazan salt that is quantified after extraction from tissues.
\The percentage reduction in viability is used to predict the irritation potential.
On the basis of the results, interpreted according to OECD 439:2015 the test item “TRISODIUM (2S)-2,6-BIS(3-CARBOXYLATOPROPANAMIDO)HEXANOATE” must be considered NOT IRRITANT for the skin.
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