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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September-December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and well documented study under 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
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:
- female
- Details on test animals or test system and environmental conditions:
- The animals were quarantined and observed daily for 5 days. A general medical -veterinary examination was performed on the day of the introductionof 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. Their sex and body weights were taken into account. All animals were marked individually. One 8-week-old animal weighing 182 g (dose of 2000 mg/kg b.w. ) was used in the sighting study. Four 9-week-old animals whose average body weight was 187 g (dose of 2000 mg/kg b.w.) were used in the main study.
Housing conditions
During the quarantine, the sighting study, and the main study, the animals were kept in air-conditioned rooms under the following conditions:
- air temperature: 20 – 23 °C
- relative ai r humidity: 35 – 61%
- artificial fluorescent lighting; lighting cycle: 12 hours light/12 hours dark
- facility air exchange: about 16 times/hour [SOP/T/9].
The animals were kept 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). In the sighting study, the animals were caged individually,whereas in the main study, there were four of them per cage.
The animals were given ad libitum access to the “Murigran” standard granulated laboratory fodder and drinking tap water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test item at a single dose of 2000 mg/kg b.w. was administered in the form of an aqueous solution in a volume of 0.5 mL/100 g b.w. using a metal stomach tube. One milliliter of the administered solution contained 400 mg of the test item (dose of 2000 mg/kg b.w.).
- Doses:
- 2000 mg /kg b.w.
- No. of animals per sex per dose:
- 4 animals (female)
- Control animals:
- not specified
- Details on study design:
- The experiment commenced with a sighting study in which the test item at a single dose of 2000 mg/kg b.w was administered to one animal.
On the grounds of the sighting study results, four animals used in the main study were given the test item at a dose of 2000 mg/kg b.w. (the animal from the sighting study which had been given the dose of 2000 mg/kg b.w. was included in the main study).
Before the administration, the animals had been fasted for about 19 hours. The test item in the form of an aqueous solution in a volume of 0.5 mL/100 g b.w. was administered using a metal stomach tube. After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted daily during the entire experiment. Body weights of the animals were determined on days 0 (di rectly before the administration of the test item), 7, and 14. After the 14-day observation period, the animals were euthanized and subjected to a necropsy
and a detailed gross examination.
Results and discussion
- Preliminary study:
- The test item at a single dose of 2000 mg/kg b.w. was administered to one animal. The test item was administered in the form of an aqueous solution in a volume of 0.5 mL/100 g b.w. using a metal stomach tube. One milliliter of the administered solution contained 400 mg of the test item (dose of 2000 mg/kg b.w.). No signs of toxicity were stated. The animal survived the experiment.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed. All animals (4) survived the test.
- Clinical signs:
- other: No clinical signs were obserwed.
- Gross pathology:
- The animals did not exhibit any pathological changes.
- Other findings:
- No other findings were observed.
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 obtained results, the test item, i.e. Zn (II) HBED can be classified to the following categories:
- category 5 / unclassified – according to the Globally Harmonized System (GHS),
- agents which are beyond categorization – 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. - Executive summary:
Following single administration of the test item at a dose of 2000 mg/kg b.w. to one animal used in the sighting study, no signs of toxicity were stated. The animal survived the experiment. Following single administration of the test item at a dose of 2000 mg/kg b.w. to the next four animals used in the main study, no signs of toxicity were stated. All animals survived the experiment. During the 14-day experiment, body weight gain was stated in all animals. Gross examinations did not reveal any pathological changes in the examined animals.
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