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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2020-04-17 to 2020-04-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted 09. Oct. 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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.: 282 - 101314 / 282 - 101315
Purity: 100 %
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: obtained from the slaughterhouse Müller Fleisch GmbH, Industri-estraße 42, 75217 Birkenfeld, Germany
- Characteristics of donor animals: between 12 and 60 months old
- Storage, temperature and transport conditions of ocular tissue: The eyes were transported in Hanks’ Balanced Salt Solution with 1 % Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 μg/mL) in a suitable cooled container within 1 hour and 7 minutes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 1035.3, 1003.4, 1003.3 mg
- The test item was ground with a mortar and pestle before use. - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- three replicates for each treatment group (negative control solution, test item or positive control solution)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
After having carefully cleaned and sterilised the cornea holders, they were kept in the incubation chamber at 32 ± 1 °C.
After the arrival of the corneas, they were examined and only corneas which were free from damages were used.
The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which prewarmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C. The formation of bubbles was prevented.
After the initial incubation, the medium was completely changed and the baseline opacity for each cornea was recorded. The baseline opacity was measured by placing the cornea holder in an opacitometer and recording the illuminance (unit: LUX).
QUALITY CHECK OF THE ISOLATED CORNEAS
None of the corneas showed an opacity greater than seven opacity units; therefore all corneas were used.
NUMBER OF REPLICATES
Three replicates
NEGATIVE CONTROL USED
HBSS: Hank’s Balanced Salt Solution (HBSS) 10-fold concentrated, diluted in demin. water (1:10), batch no.: T20200417
POSITIVE CONTROL USED
Imidazole solution: 20 % C3H4N2 (CAS-No. 288-32-4), dissolved in HBSS, batch no.: T20200417
APPLICATION DOSE AND EXPOSURE TIME
After removal of the pre-incubation medium (cMEM without phenol red), 750 μL of negative control solution, a defined amount of test item (1003.3 - 1035.3 mg) or 750 μL of positive control solution were applied to each replicate to the epithelial side of the cornea.
Exposure time of the controls and test item on the corneas was 4 hours at 32 ± 1 °C.
TREATMENT METHOD:
Closed chamber method for negative and positive controls; Open chamber-method” for test item
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After thorough rinsing the anterior chambers with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chambers were filled with cMEM without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Each cornea holder was placed in the opacitometer and the final illuminance value of each cornea was recorded at once.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD492)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 43 539.36
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: it is possible that the IVIS value of the test item is wrongly too high, because the test item color could not be removed
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: At the end of the test it was observed, that all three cornea replicates of the test item were swollen compared to the negative control.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Illuminance Values:
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1.Rep. |
2.Rep. |
3.Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
|
(I) Measured values before exposure |
1025 |
1006 |
1009 |
1046 |
1047 |
1033 |
1004 |
1007 |
999 |
(I) Measured values after exposure |
1024 |
1010 |
1023 |
1* |
1* |
1* |
349 |
337 |
346 |
* Note: due to the intrinsic colored cornea induced by the test item, the LUX value of all three test item replicates was 1.
Opacity Values Test Item and Positive Control:
Parameter |
Test Item |
Positive Control |
||||
1.Rep. |
2.Rep. |
3.Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
|
Opacity before exposure |
2.25 |
2.21 |
2.77 |
3.99 |
3.86 |
4.21 |
Opacity after exposure |
43541.46 |
43541.46 |
43541.46 |
85.46 |
89.90 |
86.54 |
Opacity Difference |
43539.21 |
43539.25 |
43538.69 |
81.47 |
86.04 |
82.33 |
Opacity Difference corrected |
43539.45 |
43539.49 |
43538.93 |
81.71 |
86.28 |
82.57 |
MeanOpacity Difference corrected |
43539.29* |
83.52 |
* Note: the high opacity value of the test item is due to the second opacity measurement. The intrin-sic color of the test item had an influence on the opacity result. The turbidity of the cornea could not be determined correctly; only the infiltrated test item color in the cornea could be measured.
Optical density at 492 nm of Negative Control, Test Item and Positive Control:
Parameter |
Negative Control |
TestItem |
Positive Control |
||||||
1.Rep. |
2.Rep. |
3.Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
|
1.Measurement |
0.043 |
0.041 |
0.045 |
0.044 |
0.047 |
0.052 |
1.485 |
1.040 |
1.967 |
2.Measurement |
0.043 |
0.042 |
0.044 |
0.043 |
0.048 |
0.054 |
1.474 |
1.033 |
1.930 |
3.Measurement |
0.043 |
0.043 |
0.044 |
0.045 |
0.045 |
0.054 |
1.471 |
1.027 |
1.919 |
|
|||||||||
1.Measurement – blank |
0.0067 |
0.0047 |
0.0087 |
0.0077 |
0.0107 |
0.0157 |
1.4487 |
1.0037 |
1.9307 |
2.Measurement – blank |
0.0067 |
0.0057 |
0.0077 |
0.0067 |
0.0117 |
0.0177 |
1.4377 |
0.9967 |
1.8937 |
3.Measurement – blank |
0.0067 |
0.0067 |
0.0077 |
0.0087 |
0.0087 |
0.0177 |
1.4347 |
0.9907 |
1.8827 |
Mean of each replicate |
0.0067 |
0.0057 |
0.0080 |
0.0077 |
0.0103 |
0.0170 |
1.4403 |
0.9970 |
1.9023 |
Mean of the 3 replicates |
0.0068 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.0009 |
0.0036 |
0.0102 |
1.4336 |
0.9902 |
1.8956 |
Corrected mean of the 3 replicates |
-- |
0.0049 |
1.4398 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No conclusive result achieved
- Conclusions:
- Under the conditions of this test, the test item Iodine induced serious eye damage on the cornea of the bovine eye. The calculated mean IVIS was 43539.36.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 55 induces serious eye damage, that should be classified as UN GHS Category I.
As the intrinsic color of the test item could not be removed from the cornea after the 4 hour incubation, the result of this study must be seen with reservations. It is possible that the IVIS value is wrongly too high and the opacity could not be determined correctly, because of the intrinsic color of the test item that could not be removed from the cornea.
Therefore no conclusive result could be achieved within this study. - Executive summary:
An in vitro study was performed to assess corneal damage potential of Iodine by quantitative measurements of changes in opacity and permeability in a bovine cornea following OECD Guideline 437 and EU Method B.47.
As test system bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old.
The test item Iodine was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, it could be observed that the whole cornea was coloured by the test item. Afterwards the opacity and permeability values were measured.
The test item was tested neat. No observations were made which might cause doubts concerning the validity of the study.
Under the conditions of this test, the test item Iodine induced serious eye damage on the cornea of the bovine eye. The calculated mean IVIS was 43539.36.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 55 induces serious eye damage, that should be classified as UN GHS Category I.
As the intrinsic color of the test item could not be removed from the cornea after the 4 hour incubation, the result of this study must be seen with reservations. It is possible that the IVIS value is wrongly too high and the opacity could not be determined correctly, because of the intrinsic color of the test item that could not be removed from the cornea.
Therefore no conclusive result could be achieved within this study.
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