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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 921-910-2 | 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(carbamoyloxy)propyl N-[(3-{[3,5-bis({5-[({[2-(carbamoyloxy)propoxy]carbonyl}amino)methyl]-1,3,3-trimethylcyclohexyl}methyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]methyl}-3,5,5-trimethylcyclohexyl)methyl]carbamate
- EC Number:
- 921-910-2
- IUPAC Name:
- 2-(carbamoyloxy)propyl N-[(3-{[3,5-bis({5-[({[2-(carbamoyloxy)propoxy]carbonyl}amino)methyl]-1,3,3-trimethylcyclohexyl}methyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]methyl}-3,5,5-trimethylcyclohexyl)methyl]carbamate
- Test material form:
- solid
- Details on test material:
- - Analytical purity: 83.9 g/100g
- Composition of test material, percentage of components: 0.2g/100g water, 13.4g/100g n-butyl acetate, 2.5g/100g 1,2-propanediol, monocarbamate
- Lot/batch No.: 389-48
- Expiration date of the lot/batch: 2019-05-23
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16/0437-1
- Expiration date of the lot/batch: 389-48
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The solid test substance was ground with pestle and mortar before application
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Details on animal used as source of test system:
- - Tissue model: EPI-200
- Tissue Lot Number: 23388
- Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Justification for test system used:
- The test system is part of an integrated approach on testing and assessment (IATA) for skin corrosion and irritation and is one of the accepted guideline studies.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm model
- Tissue batch number(s): 23388
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C and room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
NUMBER OF REPLICATE TISSUES: 2 tissues per exposure time
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 45%.
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is higher than 45%, or if the viability after 3 minutes exposure is greater than or equal to 45 % and the viability after 1 hour exposure is less than 10%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than 55% and the viability after 1 hour exposure is greater than 20%.
- The borderline evaluation was determined statistically using historic data and hence considers the variance of the test method.This evaluation is an amendment to the evaluation provided in OECD Guideline 431. - Control samples:
- yes, concurrent vehicle
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µl solid test substance with 25 ml deionized water - Duration of treatment / exposure:
- 3 minutes at room temperature and 1h in the incubator
- Duration of post-treatment incubation (if applicable):
- Rinsed tisuues were kept in 24-well plates at room temperature on assay medium until all tissues per application time were dosed and rinsed.
- Number of replicates:
- 2 tissues per exposure time
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean (Exposure period: 3 min)
- Value:
- 108.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean (Exposure period: 1h)
- Value:
- 109.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Exposure period 3 minutes: Individual and mean OD570 values, individual and mean viability values and standard deviations
Test substance | Tissue 1 | Tissue 2 | Mean | SD | |
NC | Mean OD570 | 1.527 | 1.721 | 1.624 | |
NC | Viability (% of NC) | 94.0 | 106.0 | 100.0 | 8.5 |
Test substance | Mean OD570 | 1.733 | 1.792 | 1.762 | |
Test substance | Viability (% of NC) | 106.7 | 110.4 | 108.5 | 26 |
PC | Mean OD570 | 0.159 | 0.244 | 0.202 | |
PC | Viability (% of NC) | 9.8 | 15.0 | 12.4 | 3.7 |
Exposure period 1h: Individual and mean OD570 values, individual and mean viability values and standard deviations
Test substance | Tissue 1 | Tissue 2 | Mean | SD | |
NC | Mean OD570 | 1.659 | 1.564 | 1.612 | |
NC | Viability (% of NC) | 102.9 |
97.1 |
100.0 |
4.1 |
Test substance |
Mean OD570 |
1.807 |
1.722 |
1.765 |
|
Test substance |
Viability (% of NC) |
112.1 |
106.9 |
109.5 |
3.7 |
PC |
Mean OD570 |
0.097 |
0.085 |
0.091 |
|
PC |
Viability (% of NC) |
6.0 |
5.3 |
5.6 |
0.5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria it was concluded that the test substance does not show a skin corrosion potential under the test conditions chosen.
- Executive summary:
The objective was to assess the skin irritation and corrosion potential of the test substance. By using the currently available methods a single in vitro assay is not sufficient to cover the full range of
skin irritating/corrosion potential. Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of ca. 25 μL bulk volume (about 9 mg) of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
For the corrosion test, two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after
exposure by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The final mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 108.5% and 109.5% after an exposure period of 1 hour.
Based on the results observed and by applying the evaluation criteria it was concluded that the test substance does not show a skin corrosion potential under the test conditions chosen.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)