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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Principles of method if other than guideline:
- The toxic occular irritation potential of the substance was evaluated in the cytotoxicity assay (NRU - Neutral Red Uptake) by using Balb 3T3 clone 31 cells.
- GLP compliance:
- no
- Remarks:
- existing studies not conducted in GLP but well documented
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
Test system
- Vehicle:
- other: emulsified in corn oil and diluted in culture medium.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 2000; 1000; 500; 250; 125; 62.5; 31.3; 15.6 μg/ml.
VEHICLE: the test material was first emulsified in corn oil and then diluted in culture medium. - Duration of treatment / exposure:
- 24 hours
- Details on study design:
- - Cell model used: fibroblasts Balb 3T3 clone 31cells.
- Number of repetitions and replicates used
- Test chemical concentrations used: 2000; 1000; 500; 250; 125; 62.5; 31.3; 15.6 μg/ml.
- Duration of exposure to the test chemical: 24 hours.
- Exposure conditions: 37 °C and 5 % CO2.
- Description of the procedure: the substance was added in the wells containing the cells. After the incubation period for 24 hrs, medium containing tested product was removed. The cells then washed with PBS and fresh culture medium, containing Neutral Red dye; was added to the wells. Cells were incubated at 37 °C and 5 % CO2 for 3 hours. At the end of this period NR-medium was removed, cells were washed with PBS and a solution to solubilize NR captured by cells. When solubilisation was completed, well plate was read at 540 nm.
Untreated cells are used as negative control. Cells treated with SDS scalar concentrations from 250 ug/ml to 15.6 ug/ml are used as positive control.
- Calculation of cell viability: for each tested product concentration, % cell viability was calculated according to the formula: % CELL VIABILITY = (OD540 treated *100)/OD540 negative control. Recorded mortality data were plotted against respective product concentrations to create a dose- response curve. By using curve equation IC50 parameter (or IC50, Inhibiting concentration 50), the product concentration that causes mortality in 50 % of cell population, was calculated.
- Description of evaluation and decision criteria used: If the NR50 > 1000 μg/ml the Modified Maximum Average Score (MMAS) is < 25 and the substance is considered as no/mild irritant. If the NR is between 15 μg/ml and 1000 μg/ml, the MMAS is 80.46-logNR50 and is considered as a moderate irritant. If the NR50<15 μg/ml then the MMAS is >60 and the substance is considered as a strong irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: NR50 (μg/ml)
- Value:
- > 1 000
- Vehicle controls validity:
- valid
- Remarks:
- NR50 > 1000 μg/ml
- Positive controls validity:
- valid
- Remarks:
- NR50 = 0.099 μg/ml
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The cell viability of the sample is presented in the table below for each concentration.
Table
Concentration μg/ml |
Cell viability % |
% cell mortality |
2000 | 90.57 | 9.43 |
1000 | 91.80 | 8.20 |
500 | 94.19 | 5.81 |
250 | 96.14 | 3.86 |
125 | 96.35 | 3.65 |
62.5 | 96.93 | 3.07 |
31.3 | 103.50 | -3.50 |
15.6 | 103.79 | -3.79 |
According to the obtained dose-response curve the NR50 value is > 1000 μg/ml, therefore the MMAS is < 25.
Applicant's summary and conclusion
- Interpretation of results:
- other: the substance is considered to have a no/mild irritation potential.
- Conclusions:
- The substance is considered to have a no/mild irritation eye potential.
- Executive summary:
The eye irritation potential of the substance was quantitavely assessed by the cytotoxicity assay by using the NRU (Neutral Red Uptake) assay. Fibroblasts Balb 3T3 clone 31 were exposed to the substance at eight concentrations ranging from 2000 μg/ml to 15.6 μg/ml, for 24 hours. At the end of the incubation period the medium was removed and the cells were washed with PBS and fresh culture medium and Neutral Red dye was added to the cells. The cells were incubated for 3 hours at 37 °C and 5 % CO2, after which the NR-medium was removed, the cells were washed with PBS to solubilise the NR captured by the cells. The absorbance of neutral red was measured at 540 nm. Negative controls (corn oil and culture medium) and positive control (SDS) run in parallel. The cell viability and the NR50 were calculated.
The NR50 of the sample was calculated to be > 1000 μg/ml corresponding to a MMAS < 25.
The substance is considered to have a no/mild irritation eye potential.
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