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EC number: 256-917-3 | CAS number: 51022-74-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-01-22 to 2018-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Iotroxic acid
- EC Number:
- 256-917-3
- EC Name:
- Iotroxic acid
- Cas Number:
- 51022-74-3
- Molecular formula:
- C22H18I6N2O9
- IUPAC Name:
- 3-{2-[2-(2-{[(3-carboxy-2,4,6-triiodophenyl)carbamoyl]methoxy}ethoxy)ethoxy]acetamido}-2,4,6-triiodobenzoic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - CAS No.: 51022-74-3
- Batch No.: 856W10A0003
- Aggregate State at RT: solid, powder
- Colour: white to yellowish
- Purity: 99.95 (w/w%)
- Storage Conditions: 2-8 °C, protected from light
- Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Firstly, 25 µL of sterile DPBS were applied to the epidermal surface in order to improve the contact between the powder and the epidermis. Afterwards, 25 mg (39 mg/cm2) of the test item were applied directly atop the EpiDerm tissue using an application spoon avoiding compression of the test item. The test item was spread to match size of the tissue by using a bulb-headed Pasteur pipette
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal 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:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™-Standard Model (EPI-200-SIT, MatTek)
- Tissue batch number(s): 25882, 25883
EpiDerm Kit:
The EpiDerm tissues were provided as kits (e.g. EPI-200-SIT, MatTek), consisting of the following components relevant for this study:
1x sealed 24-well plate containing e.g. 24 reconstructed epidermis units (area: 0.63 cm2); each reconstructed epidermis is attached to a cell culture insert and maintained on nutritive agar for transport (Lot No.: 25882, 25883)
2x 24-well plates
8x 6-well plates
1x bottle of assay medium (DMEM-based medium, Lot No.: 021518TMB, 022218ALE)
1x bottle of DPBS Rinse Solution (Lot No.: 092817MGKA)
1x 1 vial 5% SDS Solution (TC-SDS-5%)
25 pieces Nylon Mesh circles (8 mm diameter, 200 µm pore)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 °C for the first 35 +/- 1 min, afterwards the plates were placed under the sterile flow until 60 +/- 1 min incubation time of the first dosed tissue was over.
- Temperature of post-treatment incubation (if applicable): 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps:
the tissues were washed by filling and emptying the inserts 15 times with DPBS using a constant stream in about 1.5 cm distance from the tissue surface. Subsequently, the inserts were completely submerged three times in 150 mL DPBS and shaken to remove rests of the test item. Finally, the inserts were rinsed once from the inside and the outside with sterile DPBS. Excess DPBS was removed by blotting the bottom with blotting paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h ± 5 min
- Wavelength: 570 nm
- Filter bandwidth: ± 30 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after exposure and 42 h post-treatment incubation is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after exposure and 42 h post-treatment incubation is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg + 25 µL DPBS
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 30 µL DPBS (DPBS; Gibco, Cat. No. 14040-091, Lot No.: 1838067)
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 30 µL 5% SDS solution (TC-SDS 5%, MatTek, CAS No.: 151-21-3, Lot No: 092817MGKA). - Duration of treatment / exposure:
- 60 min +/ 1 min
- Duration of post-treatment incubation (if applicable):
- 42 h post-incubation
- Number of replicates:
- 3 tissues per dose group
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three tissues
- Value:
- 89.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- For detailed results see Table 1 in box "Any other information on results incl. tables".
Any other information on results incl. tables
Results of the Pre-Experiments:
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 was determined to be 0%.
The mixture of 25 mg of the test item per 300 µL aqua dest. or per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSClivingwas determined to be 0%.
Table 1: Result of the test item Iotroxic acid
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
2.070 |
1.785 |
2.187 |
0.100 |
0.101 |
0.100 |
1.597 |
1.872 |
1.900 |
2.045 |
1.789 |
2.133 |
0.103 |
0.107 |
0.100 |
1.630 |
1.902 |
1.875 |
|
OD570(Blank Corrected) |
2.027 |
1.741 |
2.144 |
0.057 |
0.057 |
0.056 |
1.554 |
1.828 |
1.857 |
2.002 |
1.746 |
2.090 |
0.060 |
0.063 |
0.057 |
1.587 |
1.859 |
1.832 |
|
Mean OD570of the Duplicates (Blank Corrected) |
2.014 |
1.743 |
2.117 |
0.058 |
0.060 |
0.056 |
1.570 |
1.843 |
1.844 |
Total Mean OD570of 3 Replicate Tissues (Blank Corrected) |
1.958* |
0.058 |
1.753 |
||||||
SD OD570 |
0.193 |
0.002 |
0.158 |
||||||
Relative Tissue Viability [%] |
102.9 |
89.0 |
108.1 |
3.0 |
3.1 |
2.9 |
80.2 |
94.1 |
94.2 |
Mean Relative Tissue Viability [%] |
100.0 |
3.0** |
89.5 |
||||||
SD Tissue Viability [%]*** |
9.8 |
0.1 |
8.1 |
||||||
CV [% Viabilities] |
9.8 |
3.2 |
9.0 |
* Blank-corrected mean OD570 nmof the negative control corresponds to 100% absolute tissue viability.
**Mean relative tissue viability of the three positive control tissues is≤ 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%.
Table 2: Quality Criteria
|
Value |
Cut off |
pass/fail |
Mean Absolute OD570 nmNK |
1.545 |
0.8 ≤ NK ≤ 2.8 |
pass |
Relative Viability [%] PC |
5.0 |
≤ 20% |
pass |
SD Viability[%] |
0.4 -8.1 |
≤ 18% |
pass |
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 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 a primary dermal irritation study conducted according to OECD guideline 439, the EpiDerm™-Model (EPI-200 -SIT,) was topically exposed to Iotroxic acid for 60 mins and 42 h post incubation period. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability (% negative control) was > 50% (89.5 %). Based on this result, the test item is classified as a non-irritant according to the UN GHS.
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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