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EC number: 221-516-4 | CAS number: 3129-92-8
- 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
Endpoint summary
Administrative data
Description of key information
Cyclohexylamine Benzoate showed an average relative viability of 91.5% (3 minute test) and 70.3% (1-hour test) in an in vitro EPIDERM™ skin corrosion test (SCT) performed to according to OECD TG 431. As the mean tissue viability (%) was ≥ 50% in the 3 min test and and ≥ 15% in the 1 hour test, cyclohexylamine benzoate was considered to be non-corrosive to skin, and this is not classifed for skin corrosive effects.
In an in vitro skin irritation study (EpiDerm) cyclohexylamine benzoate, showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category"
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July-August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Cyclohexylamine Benzoate
Chemical Name: Benzoic acid, compound with cyclohexylamine (1:1)
CAS No.: 3129-92-8
Batch No.: L15CHAB26
Aggregate State at RT: solid (powder)
Colour: off-white
Chemical Formula: C7H6O2.C6H13N
Active Components: Cyclohexylamine: ~50%
Benzoic Acid: ~50%
Purity: Based on GC, LC and NMR: 97%
CoA of original supplier: 99.74%
Storage Conditions: room temperature
Expiry Date: not applicable; chemical was retested in March 2018
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety. - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg (39 mg/cm2) of the test item were applied directly atop the EpiDerm tissue
- Duration of treatment / exposure:
- After dosing of all tissues, all plates were transferred to the incubator for 35 ± 1 min.
- Duration of post-treatment incubation (if applicable):
- The plates were post-incubated at 37 °C, 5.0% CO2, humidified to 95%, for 24 h. Following this incubation the tissues were transferred to new wells containing 0.9 mL fresh assay medium and incubated for additional 18 ± 2h.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 87.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 78.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 80.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test met the acceptance criteria:
- mean absolute OD570 nm of the three negative control tissues is ≥ 0.8 and ≤ 2.8
- mean relative tissue viability of the three positive control tissues is ≤ 20%
-standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18%. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item, cyclohexylamine benzoate, showed no irritant effects.
The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%.
The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category" - Executive summary:
In the present study the skin irritant potential of Cyclohexylamine Benzoate was analysed.
The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human epidermis model, was used to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant.
The test item was applied topically. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls.
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 25 mg of the test item per 300 µl aqua dest. and/ per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (82.0%) after 60 min treatment and 42 h post-incubation.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Composition: Cyclohexyamine Benzoate - 99.7%, CAS #3129-92-8
Physical Description: Off-white crystalline powder
pH: ~7 (5% aq solution)
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: Not applicable - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- water
- Details on test system:
- The test system is three dimensional Reconstructed Human Epithelium (RHE) tissue, comprised of non-transformed human-derived epidermal keratinocytes cultured to form a complex model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. Cell viability was measured by dehydrogenase conversion of MTT [(3-4,5-dimethylthiazole-2-yl)-2,5-diphenyltetrazolium bromide, thiazol blue], present in cell mitochondria, into a blue formazan salt that was quantitatively measured after extraction.
- Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL distilled water (negative control) was added to the first negative control tissue insert. After approximately 1 minute, the procedure was repeated with the second tissue.
This process was repeated for the test substance (approximately 25 mg of the test substance wetted with 25 µL of distilled water) and positive control substance (50 µL) at 1 minute intervals. - Duration of treatment / exposure:
- Testing was performed on twelve viable tissue inserts, half of which were randomly assigned to either the 3-minute or 1-hour tests.
- Duration of post-treatment incubation (if applicable):
- Plates were incubated (at ~37°C and 5% CO2) for 1 hour following the time the first tissue was exposed.
- Number of replicates:
- 2 per exposure period (3minutes, 1 hour)
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Distilled water (NC) 3 minute test
- Value:
- 100
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Distilled water (NC) 1 hour test
- Value:
- 100
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 8N KOH (PC) 3 minute test
- Value:
- 11.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 8N KOH (PC) 1 hour test
- Value:
- 1.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Cyclohexylamine Benzoate 3 minute test
- Value:
- 91.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Cyclohexylamine Benzoate 1 hour test
- Value:
- 70.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- For each test substance, negative control, and the positive control, the mean relative viability of each pair of tissues was calculated and used for classification, as follows:
Prediction from Mean Tissue Viability (expressed as % of negative control)
3 min < 50% corrosive
3 min ≤ 50% and 1 hour < 15% corrosive
3 min ≥ 50% and 1 hour ≥ 15% non-corrosive - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cyclohexylamine Benzoate showed an average relative viability of 91.5% (3 minute test) and 70.3% (1-hour test) in an in vitro EPIDERM™ skin corrosion test (SCT) performed to according to OECD TG 431.
As the mean tissue viability (%) was ≥ 50% in the 3 min test and and ≥ 15% in the 1 hour test, cyclohexylamine benzoate was considered to be non-corrosive to skin, and this is not classifed for skin corrosive effects. - Executive summary:
The in vitro EPIDERM™ skin corrosion test (SCT) was performed using three-dimensional Reconstructed Human Epithelium (RHE) obtained from MatTek Corporation (Ashland, MA).
The assay measured the destruction of the skin tissue (cytotoxicity), one component predictive of skin corrosion. The reduction of the viability of tissues exposed to chemicals in comparison to negative control treated tissue was used to predict the skin corrosivity potential.
Testing was performed on twelve viable tissue inserts, half of which were randomly assigned to either the 3-minute or 1-hour tests. Three groups containing two matrices each; one test substance group, as well as a positive control group (8N KOH) and negative control group (distilled water) were
delineated for each timed test.
The Epiderm™ Tissue inserts were conditioned in DMEM-based assay media under standard CO2 incubation conditions (~37ºC, 5% CO2). One hour after pre-incubation, the DMEM-based assay medium was refreshed and the tissues were exposed to the test and control substances. Twenty-five
milligrams of the test substance wetted with 25 µL of distilled water or 50 µL of each of the negative and positive controls were added to the designated tissue matrices. The tissues were exposed to the substances for either 3 minutes or 1 hour, depending on the assigned test. After the exposure period,
the tissues were rinsed thoroughly with Dulbecco’s Phosphate Buffered Saline (DPBS) and any excess liquid was removed.
Tissues were transferred to wells containing 300µL of MTT medium and incubated for an additional 3 hours at ~37ºC (5% CO2). The tissues were then gently rinsed with DPBS and transferred to a fresh 24-well plate for MTT extraction with isopropanol for 2 hours at room temperature. Inserts were then drained into the well of the plate and duplicate aliquots transferred to a 96-well plate for optical
density measurement.
Cyclohexylamine Benzoate showed an average relative viability of 91.5% (3 minute test) and 70.3% (1-hour test).
The positive control (8N KOH) and negative control (Distilled water) groups demonstrated appropriate effects in order to validate the study.
As per the criteria outlined in the referenced guidelines, the results indicate that Cyclohexylamine Benzoate does not cause skin corrosion.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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