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EC number: 941-679-1 | CAS number: -
- 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, other
- Remarks:
- study acc. to OECD 405 conducted in 2013
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 of November till 13 of December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and well documented study under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ZnHBED
- IUPAC Name:
- ZnHBED
- Reference substance name:
- disodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]zinc(2-)
- Cas Number:
- 1263416-97-2
- Molecular formula:
- C20 H20 N2 Na2 O6 Zn
- IUPAC Name:
- disodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]zinc(2-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Two albino rabbits of the New Zealand strain coming from the conventional husbandry of the Experimental Department of the National Research Institute of Animal Production, Balice near Kraków. The animals’ good health state was confirmed by Certificate issued by National Research Institute of Animal Production Department of Animals Genetics and Breeding in Balice. The rabbits were acclimatized for 5 days and carefully observed during this time. General medical-veterinary examination was performed on day of introduction of animals to acclimatization and detailed medical-veterinary examination was performed prior to the beginning of experiment. The animals without any pathological signs were introduced to the experiment. They were randomly selected to the experiment. The animals were individually marked. The experiment was conducted on one 7-month-old female – rabbit No. 1 and one 6-mounths-old male – rabbit No. 2.
Housing conditions
During acclimatization and experiment the animals were kept in air-conditioned room with the following parameters:
- air temperature: 20 - 22C;
- relative air humidity: 45 – 60%;
- artificial fluorescent lighting: 12 hours light / 12 hours dark
- facility air exchange about 16 times/h [SOP/T/9].
The animals were kept individually in metal cages with dimensions (length x width x height): 60 x 35 x 40 cm.
The animals were given ad libitum standard granulated "LSK" and tap water.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The second eye of animal was used as the control one
- Amount / concentration applied:
- The test item in amount of 0.085 g was administered as a single dose to conjunctival sack of one eye of rabbit by gentle distraction of lower eyelid. Then both eyelids were kept together for a moment to protect loosing of test item. The second eye was used as the control one
- Observation period (in vivo):
- Detailed clinical observations for changes in cornea, iris and conjunctiva were performed after 1, 24, 48 and 72 hours and after 7, 14 and 21 days since administration of the test item
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Before the test item application, an anesthetics were administered to each animal. The study started with a preliminary study on one animal. The test item in amount of 0.085 g was administered to conjunctival sack of one eye of the animal (rabbit No. 1). The second eye served as a control. The animal was observed for 21 days.
After evaluation of the treated eye in order to confirm irritation of its lack, the test item was given to eye of another animal (rabbit No. 2). Manner of administration was the same as in case of animal No. 1. The animal was observed for 21 days.
General clinical observations for morbidity and mortality of the animals were performed daily during the entire experiment. Detailed clinical observations for changes in cornea, iris and conjunctiva were performed after 1, 24, 48 and 72 hours and after 7, 14 and 21 days since administration of test item.
Body weight of animals was determined on day of test item administration (day 0) – directly before administration and on the last day of experiment.
After period of observation the animals were humanely killed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: average of readings after 24,47,72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: average of readings after 24,48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #1
- Time point:
- other: average of readings after 24, 48,72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- other: average of readings after 24,48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: average of readings after 24,48,72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: average of readings after 24,48,72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #2
- Time point:
- other: average of readings after 24, 48, 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- other: average of readings after 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- After administration of the test item the changes in cornea, iris and conjunctiva were stated in eye of animals. The changes were transient.
- Other effects:
- Transient discharge from coniunctivae sack. No other effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Category 2 Criteria used for interpretation of results: EU
- Conclusions:
- After administration of the test item the changes in cornea, iris and conjunctiva were stated in eye of animals. All changes were transient and they fully revrsibled before 21 days.
- Executive summary:
On the ground of the study the test item Zn (II) HBED:
- it irritates the rabbit eye – according to the Annex to the Decree of the Minister of Health of August 10, 2012 on classification of chemical substances and mixtures (Journal of Laws, item 1018),
- it belongs to category 2 – according to the Regulation (EC) of the European Parliament and of the Council No 1272/2008 of 16 December, 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006.
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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