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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- study acc. to OECD 404 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 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The experiment was conducted on three males: 8-month-old – rabbit No. 1, 7-month-old – rabbit No. 2 and 6.5-month-old No. 3.
The rabbits 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 prior to the beginning of the experiment. Only animals without any pathological signs were introduced to the experiment. They were randomly selected to it and marked individually.
Housing conditions
During the quarantine and the experiment, the animals were kept in air-conditioned rooms under the following conditions:
- air temperature: 20 - 22C
- relative air humidity: 45 – 65%
- artificial fluorescent lighting; lighting cycle: 12 hours light/12 hours dark
- facility air exchange: about 16 times/h [SOP/T/9].
The animals were individually housed in metal cages. The dimensions of the cages were 60 x 35 x 40 cm (length x width x height). Each cage was equipped with a label containing the number of the study protocol, the dates of the experiment commencement and termination (written after the termination), and sex and number of the animal.
Food and water
The animals were given ad libitum access to the "LSK" standard granulated laboratory fodder and drinking tap water.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- The test item in a amount of 0.5 g was applied on the prepared skin of rabbits.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- General clinical observations of all animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin for erythema, edema, and other pathological changes were performed 1, 24, 48, and 72 hours after the end of the treatment.
- Number of animals:
- 3
- Details on study design:
- The study commenced with a sighting study on one animal. The test item in a amount of 0.5 g was applied once to the shaved skin of one animal (rabbit No. 1) and covered with an appropriate band. The exposure lasted 4 hours. After evaluation of treated skin, in order to confirm irritation or its absence, the test item was applied to the skin of the next two animals (rabbit No. 2 and No. 3) for 4 hours in order to confirm its irritant properties. The procedure was the same as in case of rabbit No. 1. General clinical observations of the animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48, and 72 hours after the end of the exposure.
Body weights of the animals were determined on the administration day (day 0), i.e. directly before the administration, and on the last day of the experiment. After the observation period, the animals were euthanized.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- ca. 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The observations of the treated skin revealed some changes in the form of erythema. No any ohers effect were observed (no mortality, edema and any other clincal sign).
- Other effects:
- No any ohers effect were observed.
Any other information on results incl. tables
Zn (II) HBED: Acute skin irritation/corrosion study on rabbits
Administered volume of the test item |
0.5 mL |
||
Animal number |
1 |
2 |
3 |
Sex |
male |
male |
male |
Mortality |
0/1 |
0/1 |
0/1 |
General clinical signs |
none |
none |
none |
Skin erythema in the treatment area |
very slight (barely perceptible) after 1 hour and 24 hours |
very slight (barely perceptible) after 1 hour |
very slight (barely perceptible) after 1 hour |
Skin edema in the treatment area |
none |
none |
none |
Other |
none |
none |
none |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The assessed substance ZnHBED does not irrite skin.
- Executive summary:
On the grounds of the study, the test item, i.e. Zn (II) HBED can be classified to the following categories: - does not irritate the rabbit skin – 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), - is 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.
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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