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Diss Factsheets
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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 of September - 6 of December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and well documented study undner GLP conditions.
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The experiment was conducted on the Wistar male and female rats (Crl: WI(Han); outbred) obtained from the husbandry of laboratory animals of the Experimental Medicine Centre at the Medical University in Białystok kept behind the breeding barrier (number in the register of units entitled to the husbandry of laboratory animals: 0043). The animals were quarantined and observed daily for 5 days. A general medical-veterinary examination was performed on the day of the introduction of the animals to the quarantine, whereas a detailed medical-veterinary examination was performed before the beginning of the experiment. Only animals without any clinical signs were introduced to the experiment. The animals were randomized to the experiment. Thei r sex and body weights were taken into account. All animals were marked individually. Five 8-week-old males whose average body weight was 278.0 g and five 8-week-old females whose average body weight was 210.0 g were used in theexperiment.
Housing conditions
During the quarantine and the experiment, the animals were kept in air-conditioned rooms under the following conditions:
- air temperature: 21 – 23 °C
- relative ai r humidity: 35 – 58%
- artificial fluorescent lighting; lighting cycle: 12 hours light/12 hours dark
- facility air exchange: about 16 times/hour.
The animals were housed in plastic cages covered with wi re bar lids. The dimensions of the cages were 58 x 37 x 21 cm (length x width x height). After the application of the test item, each animal was housed individually. After the removal of the test item from the animals’ skin, there were five rats per cage. Each sex was kept separately. UV-sterilized wood shavings were used as bedding. Each cage was equipped with a label containing thestudy code, the dose, the dates of the commencement and the expectedtermination of the experiment, and the animals’ sex and numbers.
Food and water
The animals were given ad libitum access to the “Murigran” standard granulated fodder and drinking tap water.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- The area of skin treated with the test item was about 41 cm2 (males) and 31 cm2 (females), i.e. about 10% of the body surface area. The test item in the form of a powder was applied to gauze patches and moistened with a few drops of water. Then, the patches were laid on the prepared skin and covered with PVC foil. An elastic bandage and a sticking plaster were used to make a circular protecting band. After 24 hours, the band and the gauze patches were taken off and the residual test item was removed using water
- Duration of exposure:
- 24 h
- Doses:
- 2 000 mg/kg b.w.
- No. of animals per sex per dose:
- 5 males and 5 females. All animals received the same dose 2 000 mg/kg b.w.
- Control animals:
- no
- Details on study design:
- The test item at a single dose of 2000 mg/kg b.w. was applied to the shaved dorsal area of the trunks
of 5 males and 5 females for 24 hours.
After the application of the test item, the animals were observed for 14 days. General and detailed
clinical observations of all animals were performed daily during the entire experiment.
Body weights of the animals were determined on days 0 (di rectly before the application of the test
item), 7, and 14.
After the 14-day observation period, the animals were euthanized, dissected, and subjected to
detailed gross examinations.
Results and discussion
- Preliminary study:
- Not concern
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortaliy, all animals survived the test.
- Clinical signs:
- other: No pathological skin changes in the site of the test item application were noticed in all males. As for females, desquamation of the epidermis was stated in all females,i.e. on day 5 in female no. 1, from day 5 to day 7 in female no. 2, from day 5 to day
- Gross pathology:
- The gross examination did not reveal any pathological changes in the examined animals.
- Other findings:
- No other findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the grounds of the study, it may be stated that the median lethal dose (LD50) of Zn (II) HBED is greater than 2000 mg/kg b.w.
According to the Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling, and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006, it may be concluded that the test item, i.e. Zn (II) HBED is beyond categorization.
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