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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 271-928-3 | CAS number: 68630-95-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- other: OECD Test Guideline 442E: human Cell Line Activation Test (h-CLAT)
- Version / remarks:
- The study was performed using the h-CLAT method as detailed in XCellR8 SOP L0094 which complies with OECD TG 442E and EURL ECVAM DB-ALM Protocol No. 158.
- Principles of method if other than guideline:
- To determine the In Vitro skin sensitisation potential of Crodateric CYAP-100 using the human Cell Line Activation Test (h-CLAT) method as detailed in OECD TG 442E (adopted 29 Jul 2016) and also in EURL ECVAM DB-ALM Protocol No. 158 human Cell Line Activation Test (h-CLAT); Skin Sensitisation and Allergic Contact Dermatitis (Issued: 01 Jul 2015).
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: human Cell Line Activation Test (h-CLAT)
Test material
- Reference substance name:
- Sodium 2-heptyl-2,3-dihydro-3-(2-hydroxyethyl)-1H-imidazole-1-propionate
- EC Number:
- 271-928-3
- EC Name:
- Sodium 2-heptyl-2,3-dihydro-3-(2-hydroxyethyl)-1H-imidazole-1-propionate
- Cas Number:
- 68630-95-5
- Molecular formula:
- C15H28N2O3.Na
- IUPAC Name:
- sodium 3-[2-heptyl-3-(2-hydroxyethyl)-2,3-dihydro-1H-imidazol-1-yl]propanoate
- Test material form:
- solid
- Details on test material:
- Product name: Crodateric CYAP
Batch Number: PS-196-555
Appearance: The sample has been produced from drying of the aqueous solution of the material as sold commercially. It is observed to be a brown sticky solid
Constituent 1
- Specific details on test material used for the study:
- Supplier Croda
Test Item Name Crodateric CYAP-100
Supplier Code DEV080817DS3
Supplier Batch/Lot Number PS-196-562
CAS Number 70983-43-6
Purity 99.41% (from CofA)
Expiry Date 3 July 2018
Physical State Solid, Dark
Storage Conditions Room Temperature
Solubility Ethanol, Isopropanol
XCellR8 Test Item Code CRO1026
Study Test Item Code TA1
In vitro test system
- Details on the study design:
- Skin sensitisers have been reported to induce the expression of cell membrane markers associated with Dendritic Cell (DC) activation. The h-CLAT method is an in vitro assay that quantifies these changes in cell surface marker expression (i.e. CD86 and CD54) on a human monocytic leukaemia cell line, THP-1 cells (a cell line that mimics DCs), following 24-hour exposure to the test item. The changes of surface marker expression are measured by flow cytometry following cell staining with fluorochrome-tagged antibodies. Cytotoxicity measurement is also conducted concurrently to assess whether upregulation of surface maker expression occurs at sub-cytotoxic concentrations. The relative fluorescence intensity of surface markers compared to the solvent/vehicle control are calculated and used in the prediction model, to support the discrimination between sensitisers and non-sensitisers.
Results and discussion
- Positive control results:
- Several criteria were not considered acceptable when assessing Runs 1 and 2. The responses were considered to be negative for sensitisation however the viability at the top concentration (348.84 µg/ml) was not less than 90%. In addition, the positive control in Run 2 did not produce an upregulated CD54 signal. Therefore, these runs were repeated using a higher dose in order to yield a cytotoxic response at the top concentration (552 µg/ml top concentration).
In the positive control (Nickel Sulphate), RFI values of both CD86 and CD54 should meet the positive criteria (CD86 RFI ≥ 150 and CD54 RFI ≥ 200) and cell viability should be greater than 50%. This was achieved and the control was considered to be a Pass.
In vitro / in chemico
Results
- Key result
- Parameter:
- other: The dose that gave 75% cell viability in µg/ml.
- Value:
- 290.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the skin sensitisation potential of Crodateric CYAP-100 was assessed using the in vitro human Cell Line Activation Test (h-CLAT) method according to OECD Test Guideline 442E. After a 24h incubation with the test item the expression of cell surface markers CD54 and CD86 on THP-1 cells was measured by flow cytometry.
For Crodateric CYAP-100 the dose that yielded 75% cell viability was found to be 290.7 µg/ml. CD54 and CD86 expression were not upregulated above the sensitisation threshold by the test item at concentrations where the cell viability was ≥ 50% and therefore, Crodateric CYAP-100 was classified as a Non-Sensitiser as per the prediction model.
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.