Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 of August till 6 of December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well condcted and well documented study under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 2013 before the LLNA method has become prefered.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The experiment was conducted on the Dunkin-Hartley guinea pigs (outbred) coming from the husbandry of laboratory animals of the Charles River Laboratories in L’Arbresle cedex, France. Prior to the experiment, the animals were quarantined and observed daily for 5 days [SOP/T/6]. 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 [SOP/T/46]. Animals without any clinical signs were introduced to the experiment.
Two males whose average body weight was 489.5 g and two females whose average body weight was 476.0 g were used in the pilot study. They were 8-9 weeks old.
Fifteen males whose average body weight was 549.1 g and fifteen females whose average body weight was 466.6 g were used in the main study. They were 10 weeks old.
During the quarantine and the experiment, the animals were kept in ai r-conditioned rooms under the
following conditions:
- air temperature: 20 – 23 ºC;
- relative ai r humidity: 50 – 68%
- artificial fluorescent lighting; lighting cycle: 12 hours light/12 hours dark
- facility air exchange: about 16 times/hour [SOP/T/9].
The animals were individually housed in plastic cages. The dimensions of the cages were 58 x 37 x 21 cm (length x width x height ). The cages were covered with wire bar lids. UV-sterilized wood shavings were used as bedding.
The animals were given ad libitum access to the LSK standard granulated fodder and drinking tap water with ascorbic acid (a 0.6% solution). Water withascorbic acid was given to the animals during the quarantine period and the experiment. Ascorbic acid was not provided during skin observations taking place after stage III of the main study (challenge – topical application).
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Pilot study:
I stage - 0,5%, 15, 2%
2%, 4%, 6%
II stage - 30% and 50%
405 and 50%
Main test: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Pilot study:
I stage - 0,5%, 15, 2%
2%, 4%, 6%
II stage - 30% and 50%
405 and 50%
Main test: 50%
- No. of animals per dose:
- Pilot study:
I stage - 0,5%, 15, 2% - 1 animal
2%, 4%, 6% - 1 animal
II stage - 30% and 50% - 1 animal
405 and 50% - 1 animal
Main test: 50% - 20 animals - Details on study design:
- The experiment commenced with a pilot study which allowed for the determination of the test item concentrations to be used in the main study. These were as follows: 4% causing mild skin changes at stage I (induction - intradermal injections), 50% causing no skin changes at stage II (induction – topical application), and 50% causing no skin changes at stage III (challenge – topical application). Because the test item was a solid, the maximum concentration of the test item applied to the skin could be 50%. There were 20 animals in the treated group and 10 animals in the control group used in the main study. The main study was comprised of three parts: a two-stage induction phase and a challenge phase. At stage I of the main study, the treated animals were given intradermal injections containing a 4% aqueous solution of the test item with Freund’s Complete Adjuvant (FCA). At stage II of the main study, a 50% aqueous solution of the test item was applied to the skin in the sites of the int radermal injections. Since the 50% aqueous solution didnot cause skin irritation, on the day before stage II of the main study 10% sodium lauryl sulfate in vaseline was applied in the sites of the intradermal injections in order to create a local skin irritation.
During the induction period, the control group animals were subjected to sham treatment; it means that they were given a medium (aqua pro injectione) instead of the test item. In order to challenge sensitization, a 50% aqueous solution of the test item was applied to the right flanks of the treated andthe control animals. The medium was applied to the left flanks. Following the challenge, i.e. 24, 48, and 72 hours after the end of the exposure, the treated and the control animals were observed for skin changes. General clinical observations were performed during the main study. Detailed skin observations were conducted 24, 48, and 72 hours after the end of the exposure. Body weights of the animals were determined on day 0 and on the day of the experiment termination (before euthanasia).All animals survived the experiment. After the observation period, the animals were euthanized. - Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- Refrence test:
The following concentrations of the test item were used:
1% causing mild skin changes at stage I (induction - intradermal injections) of the main study,
30% causing mild skin changes at stage II (induction – topical application), and
10% causing no skinchanges at stage III (challenge – topical application).
During the readings, allergic skin reactions were stated in nineteen treated animals, i.e. 95% of all treated animals. In the control group animals, no pathological skin changes were stated.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reaction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema, skin dryness
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema, skin dryness.
Any other information on results incl. tables
During the experiment, the observed animals did not exhibit any general clinical signs. After the end of the experiment, body weight gain was stated in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- During the readings, allergic skin reactions were stated in seven treated animals, i.e. 35% of all treated animals. In the control group animals, no pathological skin changes were stated.
Taking the study results into consideration, the test item, i.e. Zn (II) HBED can be classified into the following categories:
- agents causing moderate sensitization – according to the Magnusson and Kligman classification,
- category 1, sub-category 1B – according to the Commission Regulation (EU) No. 286/2011 of March 10, 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling, and packaging of substances and mixtures.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.