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EC number: 270-232-7 | CAS number: 68413-60-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium feredetate
- EC Number:
- 239-802-2
- EC Name:
- Sodium feredetate
- Cas Number:
- 15708-41-5
- Molecular formula:
- C10H12N2O8FeNa
- IUPAC Name:
- Sodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; iron(+3) cation
- Reference substance name:
- FeNaEDTA
- IUPAC Name:
- FeNaEDTA
- Details on test material:
- Product brand: Sigma
Lot: 016K0107
Iron by ICP-AES: 14.4%
Sodium by ICP-AES: 6.1%
EDTA content: 69.9%
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10%, 25%, 50%
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS:
In order to determine the dose levels, a preliminary dose-range-finding study was conducted in 2 animals per dose level. Seven (7) concentrations of 0.5, 1, 2.5, 5, 10, 25 and 50% of FeNaEDTA in acetone/olive oil (3+1 v/v) and a negative control were examined. No sensitising potential could be
observed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The so-called stimulation (or LLN-) indices were calculated by dividing the average lymph node cell
counts or ear weights (punch biopsies) per group of the test item treated animals by the vehicle treated ones. Thus, in case of no stimulating effect
the index for the lymph node cell count is always below 1.4, for the ear weights 1.1 (cut-off values). Indices above 1.4 or 1.1, respectively, are
considered positive. A possible dose-relationship between the test item groups regarding the lymph node weights would have been examined by
linear regression analysis employing PEARSON's correlation coefficient. A significant dose-relationship of lypmph node weights is considered
positive. In addition, the average ear thickness per group was compared to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- U-test according to MANN and WHITNEY
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Parameter |
Group 1, negative control |
Group 2, 10% |
Group 3, 25% |
Group 4, 50% |
Group 5, positive control |
Cell count |
1.000 |
1.098 |
1.170 |
1.045 |
1.461 |
Lymph node weight |
1.000 |
1.034 |
1.138 |
1.172 |
1.517 |
Ear weight |
1.000 |
1.037 |
1.043 |
1.049 |
1.238 |
Difference of ear thickness |
1.000 |
1.070 |
1.113 |
1.116 |
1.135 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, EDTA-FeNa was not considered to be a skin sensitizer.
- Executive summary:
In a local lymph node assay according to OECD guideline 426 the skin senitisation potential of NaFeEDTA was evaluated.
Three concentrations of FeNaEDTA (10%, 25% and 50%, w/w) dissolved in acetone/olive oil (4:1 v/v) were tested in six female CBA mice per group and compared to a vehicle control group. In addition, a positive control group (30% solution v/v of hexyl cinnamic aldehyde in acetone/olive oil (4:1 v/v)) was employed. Open application of 25 μL of the appropriate dilution of the test item, the vehicle alone or the positive control (as appropriate) were administered to the dorsum of each ear on 3 consecutive days. On test day 4 lymph node cell count, ear weight (punch biopsies), ear swelling and weight of the lymph nodes were measured.
The positive control group caused the expected increases in lymph node cell count and ear weights (statistically significant at p ≤ 0.01). The values for the stimulation index of lymph node cell count and ear weight were 1.5 and 1.2, respectively.
Treatment with FeNaEDTA at concentrations of 10%, 25% or 50% (w/w) did not reveal any statistically significant increased values (p ≤ 0.01) for the lymph node cell counts and ear weights. The stimulation index of the lymph node cell count did not exceed the threshold level of 1.4, whereas the stimulation index of ear weights did not exceed the threshold level of 1.1. The slight increase of the lymph node weight in the 10%, 25% and 50% (w/w) test item treated groups is regarded as spontaneous, as no statistical significance was noted and the weights obtained are within the normal range observed for control animals.
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