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EC number: 231-152-8 | CAS number: 7440-43-9
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye 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:
- Version 25 June 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cadmium
- EC Number:
- 231-152-8
- EC Name:
- Cadmium
- Cas Number:
- 7440-43-9
- Molecular formula:
- Cd
- IUPAC Name:
- cadmium
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Product name: Cadmium
- Physical state: solid, crystalline (in the powder form), Grey
- Composition regarding the element of interest : 99.67 % Cd (contains 2.68 % CdO)
- Batch/Lot number: CDPMC190316
- Expiry date: 16 September 2020
- Storage condition of test material: Controlled room temperature (15-25°C, ≤70% relative humidity)
Constituent 1
- Specific details on test material used for the study:
- - Product name: Cadmium
- Physical state: solid, crystalline (in the powder form), Grey
- Composition regarding the element of interest : 99.67 % Cd (contains 2.68 % CdO)
- Batch/Lot number: CDPMC190316
- Expiry date: 16 September 2020
- Storage condition of test material: Controlled room temperature (15-25°C, ≤70% relative humidity)
- Safety precautions: Enhanced safety precautions (half mask at least with P3 filter cartridge, nitrile gloves, lab coat) were applied considering the supplied safety datasheet to assure personnel health and safety.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30mg - Duration of treatment / exposure:
- 10 seconds
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- treatments:
-test substance treated chicken eye: treated with 30 mg cadmium
-positive control chicken eye: treated with 30 mg imidazole
-negative control eye: treated with 30µL physiological saline (0.9% (w/v) NaCl solution
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cornea surface was rinsed thoroughly with 20ml physiological saline
- Time after start of exposure: after 10'' of exposure
SCORING SYSTEM:
The control eye and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Minor variations within ±5 minutes were considered acceptable.
The cornea thickness and cornea opacity were measured at all time points.
Fluorescein retention was measured on two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope/fluorescein
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- up to 75 minutes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- up to 240 minutes
- Value:
- 6.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- fluorescein retention score
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
Any other information on results incl. tables
The mean values of the treated eyes for maximum corneal thickness change, corneal opacity and fluorescein retention are given below. The conclusion on eye irritancy was based on the OECD guideline quantitative assessments.
The mean maximum corneal swelling up to 240 min, the mean maximum corneal opacity and the mean fluorescein retention ICE classes are used for EC and GHS classification.
Test item
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
not detected |
no data |
Mean maximum corneal swelling at up to 240 min |
6.6 % |
II |
Mean maximum corneal opacity |
not detected |
no data |
Mean fluorescein retention |
not detected |
no data |
Other Observations |
Test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse. |
|
Overall ICE Class |
no classification |
Slight corneal swelling change was observed on two test item treated eyes and in case of third eye the swelling change was not detected.The opacity change and the fluorescein retention change was not detected because the test item fully stuck on all cornea surfaces and the test item could not be removed during the study, despite best efforts to wash it off. Based on thisin vitroeye irritation study in isolated chicken eyes withCadmium,the test item was not compatible with the test system.It is concluded that further information is required for classification.
Positive Control
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
9.9 % |
II |
Mean maximum corneal swelling at up to 240 min |
19.6 % |
III |
Mean maximum corneal opacity |
4.00 |
IV |
Mean fluorescein retention |
3.00 |
IV |
Other Observations |
Imidazole was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse. |
|
Overall ICE Class |
1xIII 2xIV |
Based on these observations, the positive control substance Imidazole was classified as severe irritant according to the EU regulations. UN GHS Classification: Category 1.
Negative Control
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
1.6 % |
I |
Mean maximum corneal swelling at up to 240 min |
1.6 % |
I |
Mean maximum corneal opacity |
0.00 |
I |
Mean fluorescein retention |
0.00 |
I |
Other Observations |
None |
|
Overall ICE Class |
3xI |
The negative control Physiological saline was classified as non-irritating,according to the EU regulations. UN GHS Classification:No Category.
Table:Assessment of the general IN VITRO eye irritancy and regulatory GHS classification.
UN GHS Classification |
Combinations of the three ICE Classes |
No Category |
3×I 2×I, 1×II |
No prediction can be made |
Other combinations |
Category 1
|
3×IV 2×IV, 1×III 2×IV, 1×II* 2×IV, 1×I* Corneal opacity ≥ 3 at 30 min (in at least 2 eyes) Corneal opacity = 4 at any time point (in at least 2 eyes) Severe loosening of epithelium (in at least 1 eye) |
Remark:*:combinations of categories less likely to occur
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the performed in vitro eye irritation assay in isolated chicken eyes with Cadmium, the test item was not compatible with the test system.It is concluded that further information is required for classification.
- Executive summary:
An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline (25 June 2018).
After the zero reference measurements, the eyes were held in a horizontal position and the test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered in all cases. After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. Three eyes were treated with 30 mg test item. The three positive control eyes were treated in a similar way with 30 mg of Imidazole. The negative control eye was treated with 30 µL of physiological saline(0.9% (w/v) NaCl solution). Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) were evaluated.
The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in experiment. Thus, the study was considered to be valid.
Slight corneal swelling change (mean = 6.6%) was observed during the four-hour observation period on two test item treated eyes. In case of third eye the swelling change was not detected. The opacity change and the fluorescein retention change was not detected because the test item fully stuck on all cornea surfaces and the test item could not be removed during the study, despite best efforts to wash it off.
Based on thisin vitroeye irritation assay in isolated chicken eyes with Cadmium,the test item was not compatible with the test system.It is concluded that further information is required for classification.
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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