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EC number: 246-515-6 | CAS number: 24887-06-7
- 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:
- 9 July 2018
- 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 guidelineopen allclose all
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Zinc bis(hydroxymethanesulphinate)
- EC Number:
- 246-515-6
- EC Name:
- Zinc bis(hydroxymethanesulphinate)
- Cas Number:
- 24887-06-7
- Molecular formula:
- C2H6O6S2Zn
- IUPAC Name:
- zinc bis(hydroxymethanesulphinate)
- Reference substance name:
- Zinc sulphite
- EC Number:
- 237-046-8
- EC Name:
- Zinc sulphite
- Cas Number:
- 13597-44-9
- Molecular formula:
- H2O3S.Zn
- IUPAC Name:
- zinc sulfite
- Test material form:
- solid: particulate/powder
- Details on test material:
- white crystalline powder
purity: 98.6%
pH of 10% solution: 4.10
bulk density: 1.35
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Batch no 515
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- Eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820 Etauliers, France) where they were killed for human consumption have been used for this assay. Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. The intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline. The eyes were enucleated at Phycher afterwards.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg per eye
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- 240 minutes
- Number of animals or in vitro replicates:
- 3 eyes for the test item, 1 eye for negative control, 3 eyes for positive controls
- Details on study design:
- Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120 180 and 240 minutes post-dose.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean
- Value:
- 1.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class III
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Mean
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Other effects / acceptance of results:
- The combination the three endpoints for the test item was 1 x III, 2 x I.
The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as "Corrosive/Severe Irritant", as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as "No Category", as expected.
Applicant's summary and conclusion
- Interpretation of results:
- other: no prediction can be made
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category "no prediction can be made", as defined by the OECD Guideline No 438. Therefore the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category) with the Isolated Chicken eye test method.
- Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chicken eyes.
The test item ZINC FORMALDEHYDE SULFOXYLATE was applied, after being reduced in fine powder, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. Three eyes were treated in the same manner with a positive control and one eye with a negative control. Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120 180 and 240 minutes post-dose. The test experimental protocol was established in accordance with OECD 438 and test method B.48.
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.0, corresponding to ICE Class I;
- mean score of fluorescein retention: 1.7, corresponding to ICE Class III;
- maximal mean corneal swelling: 3%, corresponding to ICE Class I.
The combination the three endpoints for the test item was 1 x III, 2 x I.
The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as "Corrosive/Severe Irritant", as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as "No Category", as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category "no prediction can be made", as defined by the OECD Guideline No 438. Therefore the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category) with the Isolated Chicken Eye test method.
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