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EC number: 938-828-8 | CAS number: 1463474-95-4
- 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:
- August-October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- potassium 2-({2-[(carboxymethyl)[(2-hydroxyphenyl)methyl]amino]ethyl}[(2-hydroxyphenyl)methyl]amino)acetic acid iron potassium hydride chloride
- EC Number:
- 938-828-8
- Cas Number:
- 1463474-95-4
- Molecular formula:
- Not applicable for the reaction product (UVCB)
- IUPAC Name:
- potassium 2-({2-[(carboxymethyl)[(2-hydroxyphenyl)methyl]amino]ethyl}[(2-hydroxyphenyl)methyl]amino)acetic acid iron potassium hydride chloride
- Test material form:
- other: microgranules
- Details on test material:
- Description: dark red - brown microgranules
Batch: CFC-11140 (F501236001-8)
Purity/Composition: 97.2%
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Expiry date: 2 October 2015
Test substance handling: no specific handling required
No correction was made for the purity/composition of the test compound.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Details on test system:
- Test system: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 13-EKIN-029 and 13-EKIN-034 ).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
Rationale: In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
Source: SkinEthic Laboratories, Lyon, France. - Amount/concentration applied:
- The solid test substance (10.7-12.2 mg) was applied directly on top of the skin tissue.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 min
- Value:
- 109
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- HBED-Fe (UVCB) was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that HBED-Fe (UVCB) did not interact with MTT.
The mean absorption at 570 nm measured after treatment with HBED-Fe and controls are presented below Table 1.
Table 2 shows (between brackets) the mean tissue viability obtained after 15 minutes treatment with HBED-Fe (UVCB) compared to the negative control tissues. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with HBED-Fe (UVCB) compared to the negative control tissues was 80%.
The positive control had a mean cell viability of 23% after 15 minutes exposure. The OD570 of two out of three negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated with the substance or positive control was less than 4%. The standard deviation value of the percentage viability of three tissues treated with the negative control was 31%, caused by one out of three tissues. Although the SD was outside the acceptability criteria of the assay, a clear negative result was obtained by the test substance. However, since not all criteria were met, the assay was repeated at request of the sponsor.
In the repeat experiment, the relative mean tissue viability obtained after 15 minutes treatment with HBED-Fe (UVCB) compared to the negative control tissues was 109% (Table 2). Since the mean relative tissue viability for HBED-Fe (UVCB) was above 50% after 15 minutes treatment HBED-Fe (UVCB) is considered to be non-irritant. The positive control had a mean cell viability of 3% after 15 minutes exposure. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly (Table 1).
Any other information on results incl. tables
Table1 Mean absorption in the in vitro skin irritation test with HBED-Fe (UVCB) - 2nd experiment
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
|
SD |
Negative control |
1.180 |
1.134 |
1.050 |
1.121 |
± |
0.066 |
HBED-Fe (UVCB) |
1.239 |
1.252 |
1.183 |
1.224 |
± |
0.036 |
Positive control |
0.046 |
0.042 |
0.028 |
0.039 |
± |
0.010 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.045). Isopropanol was used to measure the background absorption.
In the first experiment the mean values +/- SD were as follows:
- Negative control: 1.472 +/- 0.454
- HBED-Fe (UVCB): 1.174 +/- 0.085
- Positive control: 0.408 +/- 0.057
Table2 Mean tissue viability in thein vitroskin irritation test with HBED-Fe (UVCB) - 2nd experiment
|
Mean tissue viability as % of control |
Negative control |
100 (100) |
HBED-Fe (UVCB) |
109 (80) |
Positive control |
3 (23) |
Between brackets the results of the first experiment are given.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating in an in vitro test (OECD 439).
- Executive summary:
This report describes the ability of HBED-Fe (UVCB) to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM)). The possible skin irritation potential of HBED-Fe (UVCB) was tested through topical application for 15 minutes. The study procedures described in this report were based on the most recent OECD and EC guidelines. Batch CFC 11140 (F501236001-8) of HBED-Fe (UVCB) were dark red-brown microgranules with a purity of 97.2%. Skin tissue was moistened with 5 μl of Milli-Q water and 10.7 to 12.2 mg of HBED-Fe (UVCB) was applied on top of the skin tissue for 15 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with HBED-Fe (UVCB) compared to the negative control tissues was 80%. The positive control had a mean cell viability of 23% after 15 minutes exposure. The OD570 (optical density at 570 nm) of two out of three negative control tissues was within the laboratory historical control data range The standard deviation value of the percentage viability of three tissues treated with the substance or positive control was less than 4%. The standard deviation value of the percentage viability of three tissues treated with the negative control was 31%, caused by one out of three tissues. Although the SD was outside the acceptability criteria of the assay, a clear negative result was obtained by the test substance. However, since not all criteria were met, the assay was repeated at request of the sponsor. In the repeat experiment, the relative mean tissue viability obtained after 15 minutes treatment with HBED-Fe (UVCB) compared to the negative control tissues was 109%. Since the mean relative tissue viability for HBED-Fe (UVCB) was above 50% after 15 minutes treatment HBED-Fe (UVCB) is considered to be non-irritant. The positive control had a mean cell viability of 3% after 15 minutes exposure. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly. Finally, it is concluded that this test is valid and that HBED-Fe (UVCB) is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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