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EC number: 813-880-3 | CAS number: 2055396-18-2
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- August-September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed and reported GLP study
- Justification for type of information:
- A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. Both EDTA and DTPA are chelates with similar structure and physico-chemical properties tham their toxicity are also similar. Please see RA statement in section 13.
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:
- Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)
- EC Number:
- 235-627-0
- EC Name:
- Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)
- Cas Number:
- 12389-75-2
- Molecular formula:
- C14-H18-Fe-N3-O10.H.Na
- IUPAC Name:
- Iron(3+) ion sodium 5-[bis(carboxylatomethyl)amino]-3-{[bis(carboxylatomethyl)amino]methoxy}pentanoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: yellow-green powder
Batch: CFC-10333 (429H0352)
Purity/Composition: ~97%
Test substance storage: at room temperature protected from light
Stability under storage conditions: stable
Expiry date: 1 December 2013
Test substance handling: use amber-coloured glassware or wrap container in tin-foil.
No correction was made for the purity/composition of the test compound.
Constituent 1
Test animals
- Species:
- other: in vitro
- Details on test animals or test system and environmental conditions:
- Test system: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 12-EKIN-031).
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.
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The solid test substance (11.0 to 11.7 mg) was applied directly on top of the skin tissue. DTPA-FeHNa was spread to match the size of the tissue.
- Duration of treatment / exposure:
- See below
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- See below
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 95
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
DTPA-FeHNa 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 DTPA-FeHNa did not interact with MTT.
The mean absorption at 570 nm measured after treatment with DTPA-FeHNa and controls are presented in Table 1.
Table 2 shows the mean tissue viability obtained after 15 minutes treatment with DTPA-FeHNa 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 DTPA-FeHNa compared to the negative control tissues was 95%. Since the mean relative tissue viability for DTPA-FeHNa was above 50% DTPA-FeHNa is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 4%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range (See APPENDIX 3). The standard deviation value of the percentage viability of three tissues treated identically was less than 8%, indicating that the test system functioned properly.
Table1 Mean absorption in thein vitroskin irritation test with DTPA-FeHNa
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
|
SD |
Negative control |
0.883 |
1.018 |
0.969 |
0.957 |
± |
0.069 |
DTPA-FeHNa |
0.982 |
0.849 |
0.907 |
0.913 |
± |
0.067 |
Positive control |
0.029 |
0.035 |
0.044 |
0.036 |
± |
0.007 |
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 (0.042). Isopropanol was used to measure the background absorption.
Table2 Mean tissue viability in thein vitroskin irritation test with DTPA-FeHNa
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
DTPA-FeHNa |
95 |
Positive control |
4 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not irritating in an in vitro test (OECD 439).
- Executive summary:
This report describes the ability of DTPA-FeHNa to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM)). The possible skin irritation potential of DTPA-FeHNa 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-10333 (429H0352) of DTPA-FeHNa was a yellow-green powder with a purity of ~97%. Skin tissue was moistened with 5 µl of Milli-Q water and 11.0 to 11.7 mg of DTPA-FeHNa was applied directly 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 DTPA-FeHNa compared to the negative control tissues was 95%. Since the mean relative tissue viability for DTPA-FeHNa was above 50% after 15 minutes treatment DTPA-FeHNa is considered to be non-irritant.
The positive control had a mean cell viability of 4% after 15 minutes exposure. The absolute mean OD570(optical density at 570 nm) 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 8%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that DTPA-FeHNa is non-irritant in thein vitroskin irritation test under the experimental conditions described in this report.
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