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EC number: 231-442-4 | CAS number: 7553-56-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2010-07-20 to 2010-08-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- The test article characterization was not conducted according to the Good Laboratory Practices. This is not expected to have any impact on the study.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Iodine
- EC Number:
- 231-442-4
- EC Name:
- Iodine
- Cas Number:
- 7553-56-2
- Molecular formula:
- I2
- IUPAC Name:
- iodine
Constituent 1
- Specific details on test material used for the study:
- Batch No.: Pallets 38361-38380
Purity: 99.8%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratory
- Age at study initiation: Screening (9 wks old), Quantitative Irritation Testing (10 wks old) and Main test (11 wks old)
- Weight at study initiation: 20.4 - 21.2 g for screen animals, 20.3 - 23.1 g for quantitative irritation test (QIT) animals, 21.2 - 25.5 g formain study animals
- Housing: Individual suspended wire-bottom cages
- Diet (e.g. ad libitum): PMI Rodent Chow ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: at least 5 days prior to start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 44-76
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 1, 0.5, and 0.25%
- No. of animals per dose:
- 5 mice per group
- Details on study design:
- Dosing:
Preliminary Dermal Irritation Screen: Three groups of CBA/J mice (2 animals per group) were treated with increasing concentrations of test item, (5%, 10% and 25%) in DMSO. Treatment was made by topical application of the test article concentrations to the dorsum of each ear once daily for three consecutive days (at approximately the same time each day). The test substance was spread over the entire dorsal surface of the ear using a micropipette at 25μL/ear.
Quantitative Irritation Test (QIT): Six groups of two CBA/J mice per group were treated with six concentrations (0.05%, 0.1 %, 0.25%, 0.5%, 1 % and 2.5%) of the test article in DMSO in the same manner as in the irritation screening study.
Main Test: Five groups of CBA/J mice (5 animals per group) were treated by topical application of the test article concentrations (0.25%, 0.5% and 1.0%), vehicle control or positive control in the same manner as in the screen.
Type and Frequency of Observations:
AII animals in the study were observed once daily throughout the study for clinical signs, either of local irritation at the application site or systemic toxicity, and for mortality
Measurements:
Body weights were recorded on Day 1, immediately prior to dosing, and on Day 6 (prior to sacrifice in the screen, and prior to BrdU injection in the main test). Ear thickness measurements were performed on Day 1 prior to dosing, on Day 3 before the third test article application (approximately 48 hours after the first test article application), and on Day 6 before sacrifice (approximately 120 hours after the first dose and 72 hours after the third dose). Changes in ear thickness on Day 3 and Day 6 relative to Day 1 were expressed as a percent of the Day 1 pre-dose values. Ear thickness increases of 25% or more were considered biologically significant (based on the scientific literature and historical laboratory data) and deemed indicative of a greater than moderate local dermal irritation response.
Node Isolation and Processing:
At 5 hours pre-sacrifice, mice were intraperitoneally injected 200μL of phosphate-buffered saline (PBS) containing BrdU. At sacrifice, each mouse lymph node set were excised and a single-cell suspension of lymph node cells was prepared. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- For each test group, the individual animal stimulation index (SI) values, along with the mean group SI and standard deviation were calculated. Student's t-Test were run to statistically compare each group to the control group.
Results and discussion
- Positive control results:
- alpha-hexyl cinnamic aldehyde stimulation index (SI): 6.4
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 0.25% group
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 0.5% group
- Parameter:
- SI
- Value:
- 2.2
- Test group / Remarks:
- 1% group
- Cellular proliferation data / Observations:
- Test Article Formulation and Dosing: The test article formed a homogenous solution in the vehicle, DMSO. No difficulties were experienced with the application of the test article to the ears or with the retention of test article by the ear surface. However, in the screen, test material appeared to stain the ears and hair at the dose sites beginning on Day 2. This did not affect ear measurements.
Body Weights: Body weight changes were noted but were not significant (<2 g).
Mortality and Systemic Observations: AII animals survived the in-life phase of the study and were observed to be normal.
Any other information on results incl. tables
Irritation Screening
Table 1: Results of the initial test irritation
Ear Measurements | Day 1 | Day 3 | Day 6 | Mean Ear Thickness (mm) | %Difference |
||||||||||
AN # | Left | Right | Left | Right | Left | Right | Pre-Dosing (Day 1) | 48 Hr (Day 3 | End In-Life (Day 6) |
Day 3- Day 1 |
Day 6- Day 1 |
||||
5% Test item | 1 | 0,18 | 0,18 | 0,23 | 0,23 | 0,44 | 0,48 | 0,18 | 0,23 | 0,46 | 28%a | 156%a | |||
2 | 0,19 | 0,18 | 0,23 | 0,24 | 0,48 | 0,44 | |||||||||
10% Test item | 3 | 0,20 | 0,20 | 0,31 | 0,34 | 0,50 | 0,48 | 0,21 | 0,32 | 0,47 | 52%a | 124%a | |||
4 | 0,21 | 0,21 | 0,31 | 0,32 | 0,41 | 0,50 | |||||||||
25% Test item | 5 | 0,21 | 0,20 | 0,36 | 0,38 | 0,54 | 0,57 | 0,20 | 0,36 | 0,55 | 80%a | 175%a | |||
6 | 0,19 | 0,20 | 0,35 | 0,36 | 0,55 | 0,55 | |||||||||
a = an increase in ear thickness of 25% indicates a positive dermal irritation response |
Table 2: Results of the quantitative irritation screening
Ear Measurements | Day 1 | Day 3 | Day 6 | Mean Ear Thickness (mm) | %Difference | ||||||||||
AN # | Left | Right | Left | Right | Left | Right | Pre-Dosing (Day 1) | 48 Hr (Day 3 | End In-Life (Day 6) |
Day 3- Day 1 |
Day 6- Day 1 |
||||
0.05% Test item | 1 | 0,19 | 0,21 | 0,21 | 0,21 | 0,21 | 0,23 | 0,20 | 0,22 | 0,22 | 10% | 10% | |||
2 | 0,20 | 0,21 | 0,21 | 0,23 | 0,21 | 0,23 | |||||||||
0.1% Test item | 3 | 0,21 | 0,20 | 0,22 | 0,22 | 0,20 | 0,24 | 0,21 | 0,22 | 0,23 | 5% | 10% | |||
4 | 0,21 | 0,22 | 0,22 | 0,23 | 0,24 | 0,24 | |||||||||
0.25% Test item | 5 | 0,19 | 0,21 | 0,19 | 0,18 | 0,21 | 0,22 | 0,20 | 0,19 | 0,23 | -5% | 15% | |||
6 | 0,18 | 0,20 | 0,18 | 0,21 | 0,23 | 0,24 | |||||||||
0.5% Test item | 7 | 0,20 | 0,21 | 0,21 | 0,21 | 0,21 | 0,22 | 0,20 | 0,20 | 0,22 | 0% | 10% | |||
8 | 0,20 | 0,20 | 0,21 | 0,18 | 0,22 | 0,22 | |||||||||
1% Test item | 9 | 0,19 | 0,18 | 0,19 | 0,20 | 0,23 | 0,22 | 0,19 | 0,19 | 0,22 | 0% | 16% | |||
10 | 0,19 | 0,19 | 0,19 | 0,19 | 0,21 | 0,23 | |||||||||
2.5% Test item | 11 | 0,20 | 0,19 | 0,22 | 0,21 | 0,34 | 0,33 | 0,20 | 0,22 | 0,35 | 10% | 75%a | |||
12 | 0,20 | 0,19 | 0,21 | 0,23 | 0,35 | 0,38 | |||||||||
a = an increase in ear thickness of 25% indicates a positive dermal irritation response |
Main Study
Table 3: Irritation as Measured by Ear Swelling (% Change Day 1 to Day 6)
DMSO |
25% HCA |
0.25% Test item |
0.5% Test item |
1% Test item |
10.5% |
63.2% |
15% |
15.8% |
15% |
The EC3, the concentration at which the stimulation index is equal to 3 (calculated to determine skin sensitization potency) could not be calculated for test item.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- To determine the sensitising potential of topically applied test item (iodine), a Local Lymph Node Assay was performed in female mice. The study followed guideline EPA OPPTS 870.2600 (2003) and OECD guideline for the Testing of Chemicals No. 429 (2002). The stimulation index of the substance was 1.0 at 0.25%, 1.8 at 0.5% and 2.2 at 1%. The test item (iodine) showed no skin sensitiser potential.
- Executive summary:
To determine the sensitising potential of topically applied test item (iodine), a Local Lymph Node Assay was performed in female mice. The study followed guideline EPA OPPTS 870.2600 (2003) and OECD guideline for the Testing of Chemicals No. 429 (2002).
In order to select the doses for the main study, an irritation screening was performed with solutions of 25%, 10%and 5% of test item in dimethyl sulfoxide (DMSO) using two animals per concentration. As irritation was observed (ear swelling > 25%) in the animals, a quantitative irritation test was carried out using 6 concentrations of test item (2 animals per concentration).
For the main study, solutions of 0.25%, 0.5% and 1% test item iodine) in DMSO were applied to the dorsum of both ears one time per day three consecutive days. Control mice were treated with the vehicle (alone) and an additional group with 25% alpha-hexyl cinnamic aldehyde (as positive control). Test item was negative for excessive local irritation (<25% increase in ear thickness) suggesting to be non irritant at the concentrations tested. The stimulation index of the substance was 1.0 at 0.25%, 1.8 at 0.5% and 2.2 at 1%.
Based on these results, test item (iodine) is not a considered a dermal sensitizer agent under testing conditions. The EC 3 concentration could not be calculated.
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