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EC number: 253-981-4 | CAS number: 38517-37-2
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Remarks:
- EpiIntestinal Small Intestine Tissue Model was used to compare the registered molecule (target), the source and other acylglutamates that have similar structure in order to better justify Read Across use.
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 21 June 2021 to 25 June 2021
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- The test was used to evaluate toxicological behaviuor of registered substance (target) agint the souce substmce and different acylglutamates with same structure but different fatty chain. No significative differences could be found. This helps Read Across Justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
- Type of study / information:
- In vitro study
Results and discussion
Any other information on results incl. tables
Methods are adapted from MatTekprotocol MK-24-007-0083
Preliminary test Test item checked for MTT interference
Day 1: Tissue receipt and overnight conditioning
Day 2: Exposure to and removal of test item that has been diluted to a betaine content of 29.6% and pH adjusted to a pH of 7 ±0.2; and reference items (see table)
MTT viability test
Day 3: Absorbance optical density (OD) read at 570 nm.
OD values exported to the analysis spreadsheet
Item | Number of tissues | Amount applied per tissue | How applied | Exposure |
Test Item | 3 | Single dose of 50µldiluted and pH adjusted test item | To the surface of the EpiIntestinalTM tissue model. | 15, 60 and 120 minutes |
PC | 3 | Single dose of 100µl PC | 15, 60 and 120 minutes | |
NC | 3 | Single dose of 100µl NC | 60 minutes |
After the exposure period indicated above all test chemicalswere removed by rinsing with DPBS.
Results from the MTT assay were entered into a bespoke Microsoft Excel workbook containing formulae to convert the raw results to a percentage viability for the test item relative to the negative control. From this, an ET50 value (the effective time at which the test item caused a 50% reduction in tissue viability) and dose response curve isgenerated (data allowing).
The assay was valid.
Acceptance criterion | Result | Outcome |
The ET50 of the positive control should bebetween 15 and 55 minutes. | 29.35mins | Pass |
SD of viability for all test items and controls must be <18%. | The highest SD of viability was for the PC at 15 minutes: 11.3% | Pass* |
* This is after the removal of one value from the PC at 60 minutes (tissue 2).
12Results
12.1 Preliminary test
The preliminary test confirmed that none of the four items tested interfered with MTT.
12.1 Viability
The percentage viability value for the EpiIntestinalTM models exposed to the four itemsrelative to the negative control set to 100% were calculated.
No outlierswereidentified.
Condition | Tissue | Raw data | OD Mean | Viability (%) | Mean (%) | SD (%) | |
NC 60 min | 1 | 1.836 | 1.896 | 1.866 | 103.7 | 100.0 | 3.6 |
2 | 1.773 | 1.814 | 1.793 | 99.7 | |||
3 | 1.723 | 1.752 | 1.737 | 96.6 | |||
PC 15 min | 1 | 1.362 | 1.385 | 1.373 | 76.3 | 71.4 | 11.3 |
2 | 1.048 | 1.055 | 1.051 | 58.4 | |||
3 | 1.437 | 1.419 | 1.428 | 79.4 | |||
PC 60 min | 1 | 0.615 | 0.636 | 0.625 | 34.8 | 27.2 | 10.6 |
2 | 1.154 | 1.217 | 1.185 | 65.9 | |||
3 | 0.351 | 0.359 | 0.355 | 19.7 | |||
PC 120 min | 1 | 0.091 | 0.097 | 0.094 | 5.2 | 5.0 | 0.8 |
2 | 0.099 | 0.106 | 0.102 | 5.7 | |||
3 | 0.075 | 0.072 | 0.073 | 4.1 | |||
TA1 15 min | 1 | 0.164 | 0.171 | 0.167 | 9.3 | 9.3 | 0.4 |
2 | 0.175 | 0.175 | 0.175 | 9.7 | |||
3 | 0.156 | 0.162 | 0.159 | 8.8 | |||
TA1 60 min | 1 | 0.135 | 0.138 | 0.136 | 7.6 | 8.3 | 0.7 |
2 | 0.151 | 0.151 | 0.151 | 8.4 | |||
3 | 0.160 | 0.160 | 0.160 | 8.9 | |||
TA1 120 min | 1 | 0.098 | 0.098 | 0.098 | 5.4 | 7.2 | 1.6 |
2 | 0.155 | 0.151 | 0.153 | 8.5 | |||
3 | 0.140 | 0.140 | 0.140 | 7.8 | |||
TA2 15 min | 1 | 0.116 | 0.122 | 0.119 | 6.6 | 5.2
| 1.2
|
2 | 0.074 | 0.078 | 0.076 | 4.2 | |||
3 | 0.086 | 0.093 | 0.089 | 4.9 | |||
TA2 60 min | 1 | 0.083 | 0.083 | 0.083 | 4.6 | 5.5 | 1.0 |
2 | 0.123 | 0.115 | 0.119 | 6.6 | |||
3 | 0.098 | 0.098 | 0.098 | 5.4 | |||
TA2 120 min | 1 | 0.081 | 0.081 | 0.081 | 4.5 | 4.2 | 0.3 |
2 | 0.078 | 0.075 | 0.076 | 4.2 | |||
3 | 0.069 | 0.073 | 0.071 | 3.9 | |||
TA3 15 min | 1 | 0.741 | 0.738 | 0.740 | 41.1 | 43.7 | 2.3 |
2 | 0.817 | 0.785 | 0.801 | 44.5 | |||
3 | 0.816 | 0.817 | 0.817 | 45.4 | |||
TA3 60 min | 1 | 0.436 | 0.433 | 0.435 | 24.2 | 25.3 | 4.7 |
2 | 0.383 | 0.380 | 0.382 | 21.2 | |||
3 | 0.556 | 0.537 | 0.547 | 30.4 | |||
TA3 120 min | 1 | 0.413 | 0.409 | 0.411 | 22.9 | 24.1 | 2.5 |
2 | 0.400 | 0.405 | 0.403 | 22.4 | |||
3 | 0.487 | 0.483 | 0.485 | 27.0 | |||
TA4 15 min | 1 | 0.071 | 0.070 | 0.071 | 3.9 | 3.8 | 0.1 |
2 | 0.063 | 0.073 | 0.068 | 3.8 | |||
3 | 0.061 | 0.073 | 0.067 | 3.7 | |||
TA4 60 min | 1 | 0.076 | 0.083 | 0.080 | 4.4 | 4.7 | 0.3 |
2 | 0.091 | 0.089 | 0.090 | 5.0 | |||
3 | 0.080 | 0.083 | 0.082 | 4.5 | |||
TA4 120 min | 1 | 0.083 | 0.069 | 0.076 | 4.2 | 4.0 | 0.2 |
2 | 0.072 | 0.070 | 0.071 | 4.0 | |||
3 | 0.067 | 0.069 | 0.068 | 3.8 |
*orange value : excludedfrom the data processing. Whenremoved the SD% wasbelow 18%.
12.2ET50Determination
After normalisation to the negative control, percentage viability values were plotted against time (mins) on a semi-log graph.
Applicant's summary and conclusion
- Conclusions:
- The ET50was not able to be calculated for any of the fours items (target, source and other two acylglutamates) tested in the study 21ZSZ01EIN because the viability (%) for all timepoints recorded and was below 50% and therefore the ET50 value was subsequently classified as being <15 minutes
The PC met its required acceptance criteria and had a calculated ET50value of 29.35 minutes. No differences could be found among the 4 molecules - Executive summary:
The epithelial lining of the gastrointestinal (GI) tract is a gatekeeper for entry of orally ingested nutrients and xenobiotics including medicaments. The small intestine has a well organized structure containing proliferative cells which migrate along the crypt-villi axis and differentiate into functionally mature epithelial cells. To enable in vitro study of the small intestinal epithelium, MatTek has developed Epilntestinal, a model of the human small intestine.
Epilntestinal is a 3D reconstructed tissue model produced from normal, human-derived small intestine epithelial and endothelial cells and fibroblasts (EPilntestinalFT). The highly differentiated tissue model is produced at the air-liquid-interface (ALI) in easy-to-handle tissue culture inserts using serum-free medium. Structural analysis of the tissue model demonstrates columnar shaped basal cells and Kerckring folds. Ultrastructurally, Epilntestinal exhibits brush borders, functional tight junctions and mucous secreting granules mimic the in vivo tissue.
The study will be performed using the EpiIntestinalTM reconstructed tissue model SMI-100 (MatTek Corporation) using a method based on the MatTekEpiIntestinal™ Small Intestine Tissue Model (SMI-100) Use Protocol and MTT Tissue Viability (ET-50) (MK-24-007-0083 issued 02/23/2016).
This in vitro assessment of small intestine tissues viability is based on the effective time at which four test items caused a 50% reduction in tissue viability (ET50).
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.
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