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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 254-991-1 | CAS number: 40594-65-8
- 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:
- September 3rd to 5th, 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted July 26th, 2013
- GLP compliance:
- no
- Remarks:
- not-GLP study but considered as reliable based on the reporting of the study
Test material
- Reference substance name:
- 5-methyl-2-(isopropyl)cyclohexyl nicotinate
- EC Number:
- 254-991-1
- EC Name:
- 5-methyl-2-(isopropyl)cyclohexyl nicotinate
- Cas Number:
- 40594-65-8
- Molecular formula:
- C16H23NO2
- IUPAC Name:
- 5-methyl-2-(isopropyl)cyclohexyl nicotinate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal epidermall keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstructed artificial human skin model comprising normal human epidermal keratinocytes, growing as an integrated three-dimensional cell culture model, perfectly mimicking the human skin in vitro. The model exhibits normal barrier functions (presence of a differentiated stratum corneum). At the surface, a well-differentiated stratum corneum is present, over which the product to be tested is placed. Below the epidermis there is a semi-permeable membrane that communicate with the inferior well where the culture medium is placed (undernatant).
- Tissue batch number: 14-RHE-005.
- Supplier: Skinethic (Lyon).
- Mainenance medium batch: 14MA046.
- Growth medium batch: 14MPE56.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature.
- Temperature of post-treatment incubation: 37 °C (and 5 % CO2).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ml MTT solution.
- Incubation time: 3 hours.
- Incubation temperature: 37 °C.
- Removal of MTT solution: after the incubation period of 3 hours, the solution was removed and replaced with 1500 μl/well of isopropanol, with further 2 hours incubation at room temperature under medium speed shaking.
- Measurement of absorbance: at 550 nm with a microplate reader (Tecan modello Sunrise remote).
- Calculation of cell viability: % cell viability = [OD(550nm) test product/meanOD(550nm)negative control] x 100.
ACCPTANCE CRITERIA
- for negative control (CN): the mean OD value of the 3 tissue has to be ≥ 1.2, the standard deviation has to be ≤ 18 %.
- for positive control (CP): the viability mean (expressed as % of the NC) has to be < 40 % the standard deviation has to be ≤ 18 %.
- for the sample : the standard deviation has to be ≤ 18 %.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the mean tissue viablity is ≤ 50 %.
- The test substance is considered to be non-irritant to skin if the mean tissue viability is > 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 μl. - Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 117.21
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The cell viability of the test, negative and positive control are presented in the table below.
Table
Sample | %mean cell viability (SD) 42 hrs incubation |
Comment |
Test material |
117.21 (5.16) | Non irritant |
SLS 5 % | 1.81 (0.11) | Irritant |
Negative control (CN) |
100.00 (6.51) | Non irritant |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- The substance is not a skin irritant.
- Executive summary:
The skin irritation of the substance was evaluated in-vitro in the SkinEthic 3D reconstructed artificial human skin model, according to the OECD Guideline 439. The test material was applied on each tissue in three replicates. After 42 minutes of exposure, the substance was removed and the tissue was incubated at 37 °C, 5 % CO2 for 42 hours. At the end of the exposure the MTT assay was performed to evaluate the tissue cell viability. Negative controls (phosphate buffer) and positive (5 % SLS) controls run in parallel.
The tissue cell viability was 117.21 % for the substance, 1.81 % for positive control and 100.00 for negative control.
The tissue viability is more than 50 % therefore the substance is considered as a non-skin irritant.
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.