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Diss Factsheets
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EC number: 244-848-1 | CAS number: 22224-92-6
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-02-16 to 2015-02-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 6 July 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fenamiphos
- EC Number:
- 244-848-1
- EC Name:
- Fenamiphos
- Cas Number:
- 22224-92-6
- Molecular formula:
- C13H22NO3PS
- IUPAC Name:
- {ethoxy[3-methyl-4-(methylsulfanyl)phenoxy]phosphoryl}(propan-2-yl)amine
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: kit: EPISKIN-SM™, supplier: SkinEthic
- Source strain:
- not specified
- Justification for test system used:
- This test uses the EPISKIN-SM™ reconstructed human epidermis model (SkinEthic) which consists of human keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- water
- Remarks:
- aqua dest.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM™ reconstructed human epidermis model (SkinEthic)
This skin model consists of normal (non-cancerous), adult human-derived 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. A highly differentiated and stratified epidermis model is obtained after 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
- Tissue batch number: 15-EKIN-007
- Date of initiation of testing: 2015-02-16
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure: 37 ± 1 °C
- Temperature of post-treatment incubation: 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing steps: washing was done with PBS to remove any residual test item or control item. Excess PBS was removed by blotting bottom with blotting paper.
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h ± 5 min
- Spectrophotometer: yes
- Wavelength: 570 nm
- Filter: not specified
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes
- Barrier function: IC50 determination (SDS concentration, MTT test, n = 14); specification ≥ 1.5 mg/mL; result: 2.2 mg/mL
- Morphology: Well-differentiated epidermis consiting of a basal layer, several spinous and granular layers and a thick stratum corneum.
- Contamination: no
- Reproducibility: yes
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL
The test item is considered to be irritant to skin, if the tissue viability after 15 min. of exposure and 42 h of post-incubation is less or equal to 50%. The test substance may be considered as non-irritant to skin if the tissue viability after exposure and post-treatment incubation is higher than 50%.
ACCEPTABILITY CRITERIA:
The test meets acceptance criteria if:
- OD570 nm of the blank is < 0.1
- mean OD570 nm of the three negative control tissues is ≥ 0.6 and ≤ 1.5.
- mean relative tissue viability of the three positive control tissues is ≤ 40%.
- the standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is < 18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 mg + 10 μL aqua dest
- Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 89.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Pre-Experiments
The mixture of 10 mg test item per 2 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. The mixture of 10 mg of the test item per 90 µL aqua dest. showed no colouring detectable by unaided eye-assessment.
Acceptance of results
The controls confirmed the validity of the study. The mean OD570 of the six blank values was < 0.1. The mean absolute OD570 of the three negative control tissues was ≥ 0.6 and ≤ 1.5. The mean relative tissue viability (% negative control) of the positive control was ≤ 40% (18.1%). The maximum standard deviation of viability of replicate tissues of the negative and positive control was < 18% (4.9% - 6.1%).
Any other information on results incl. tables
Table 1: Result of the Test Item
Name | Negative Control | Positive control | Test item | ||||||
Tissue | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
absolute OD570 | 1.148 1.141 | 1.135 1.153 | 1.056 1.051 | 0.185 0.210 | 0.200 0.205 | 0.324 0.301 | 1.134 1.197 | 1.045 1.082 | 0.789 0.784 |
OD570 (blank-corrected) | 1.104 1.097 | 1.091 1.109 | 1.012 1.007 | 0.141 0.166 | 0.156 0.161 | 0.280 0.257 | 1.090 1.153 | 1.001 1.038 | 0.745 0.740 |
mean OD570 of the duplicates (blank-corrected) | 1.100 | 1.100 | 1.010 | 0.154 | 0.158 | 0.268 | 1.121 | 1.020 | 0.743 |
total mean OD570 of 3 replicate tissues (blank-corrected) | 1.070* | 0.193 | 0.961 | ||||||
relative tissue viabilities [%] | 102.8 | 102.8 | 94.4 | 14.4 | 14.8 | 25.1 | 104.8 | 95.3 | 69.4 |
mean relative tissue viability [%] | 100.0 | 18.1** | 89.8 | ||||||
SD tissue viability [%]*** | 4.9 | 6.1 | 18.3 |
* Corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is ≤ 40%.
*** The standard deviation (SD) obtained from the three concurrently tested tissues is < 18%. The test item treated tissue is excluded from this statement.
Table 2: Quality criteria
| Value | Cut off | pass/fail |
Mean OD570 nm Blank | 0.044 | < 0.1 | pass |
Mean Absolute OD570 nm NC | 1.11 | 0.6 ≤ NC ≤ 1.5 | pass |
Mean Relative Viability [%] PC | 18.1 | ≤ 40% | pass |
SD of Viability [%] | 4.9 – 18.3 | < 18% | fail |
Table 3: Historical data
| OD570 blank | Absolute OD570 NC | Relative Viability [%] PC | SD of Viability [%] |
Mean | 0.044 | 0.883 | 12.3 | 8.4 |
SD | 0.001 | 9.1 | 9.1 | 8.6 |
n | 54 | 54 | 54 | 248 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant”.
- Executive summary:
In the present study the skin irritant potential of the test substance was analysed. The EPISKIN-Standard Model™ (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404) 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 is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) after a 15 minutes exposure and 42 hours post incubation period and compared to those of the concurrent negative controls. In this study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
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.
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