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EC number: 255-965-2 | CAS number: 42844-93-9
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- according to OECD 406
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- the study was conducted in 1982
Test material
- Reference substance name:
- [1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel
- EC Number:
- 255-965-2
- EC Name:
- [1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel
- Cas Number:
- 42844-93-9
- Molecular formula:
- C29H18N4NiO3
- IUPAC Name:
- Nickel, [1,3-dihydro-5,6-bis[[[2-(hydroxy-kO)-1-naphthalenyl]methylene]amino-kN]-2H-benzimidazol-2-onato(2-)]-, (SP-4-2)-
- Test material form:
- solid: nanoform
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain specifics: Dunkin-Hartley albino guinea pig
- Source: Sueddeutsche Versuchstierfarm, Tuttlingen Germany
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: males 354 - 495 g; females 401 - 589 g
- Acclimation period: 1 week under test conditions
- Housing: individually in Macrolon cages type III with wire mesh tops and standardized granulated soft wood bedding
- Diet (e.g. ad libitum): pelleted standard KLIBA 23/342/1 guinea pig breeding/maintenance diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: physiological saline, propylene glycol, Freund's Adjuvant, white vaseline
- Route:
- intradermal
- Concentration / amount:
- INDUCTION EXPOSURE:
1st week: 0.1 % test substance in physiological saline plus propylene glycol (1:1) and the solvent negative control
0.1 mL were injected respectively
2nd and 3rd week: test substance dissolved in a mixture of physiological saline plus plus propylene glycol (1:1) plus Freund's Adjuvant
0.1 mL were injected respectively
CHALLENGE EXPOSURE:
intradermal: 0.1 % test substance in physiological saline plus propylene glycol (1:1)
0.1 mL were injected respectively
epicutaneous: 30 % test substance in soft white vaseline, equal amount per 2 x 2 cm patch applied - Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiological saline, propylene glycol, Freund's Adjuvant, white vaseline
- Route:
- intradermal
- Concentration / amount:
- INDUCTION EXPOSURE:
1st week: 0.1 % test substance in physiological saline plus propylene glycol (1:1) and the solvent negative control
0.1 mL were injected respectively
2nd and 3rd week: test substance dissolved in a mixture of physiological saline plus plus propylene glycol (1:1) plus Freund's Adjuvant
0.1 mL were injected respectively
CHALLENGE EXPOSURE:
intradermal: 0.1 % test substance in physiological saline plus propylene glycol (1:1)
0.1 mL were injected respectively
epicutaneous: 30 % test substance in soft white vaseline, equal amount per 2 x 2 cm patch applied
- No. of animals per dose:
- Vehicle control group vaseline pure: 24 animals
Treatment group: 24 animals - Details on study design:
- MAIN STUDY:
A. INDUCTION EXPOSURE
- No. of exposures: injections on days 1, 3, 5 in the 1st week, on days 8, 10, 12 and 15, 17, 19 in the 2nd and 3rd week
- Site: shaved flank for intradermal injections
- Concentrations: see above
B. CHALLENGE EXPOSURE
- No. of exposures: 1 intradermal injection, 1 epicutaneous exposure
- Day(s) of challenge: day 32 of study
- Site: untreated flank
- Concentrations: primary non irritant concentration 30 % epicutaneous, 0.1 % intradermal
- Evaluation (hr after challenge): 24 h after intradermal challange, 24 h after 24 h lasting epicutaneous challange treatment - Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
Results and discussion
- Positive control results:
- in a separate test the incidence of the guinea pig strain to allergic reactions was tested with the known allergen dinitrochlorobenzene. Significant positive results were obtained in all animals with this compound.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- no positive reactions observed
- Remarks on result:
- other: Reading: other: reading after first challange (intradermal). . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 24.0. Clinical observations: no positive reactions observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- no positive reactions observed
- Remarks on result:
- other: Reading: other: reading after first challange (intradermal). . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 24.0. Clinical observations: no positive reactions observed.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no positive reactions observed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: reading after second challange (24 h epicutaneous treatment). . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no positive reactions observed.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no positive reactions observed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: reading after second challange (24 h epicutaneous treatment). . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no positive reactions observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guinea pig maximisation test according to OECD 406, the test item did not cause any skin reactions in all 24 animals of the treatment group after challenge exposures. Based on the results of this study the test item has to be regarded as not sensitising.
- Executive summary:
Testing for sensitizing properties of the test item was performed in 12 male and 12 female guinea pigs according to OECD guideline 406. Intradermal induction was performed by 9 injections (3 injections weekly) within 3 weeks using a 0.1 % test item preparation. In the 1st week a 1:1 mixture of physiological saline with propylene glycol was applied as vehicle, In the 2nd and 3rd week Freund's Adjuvant was added to the vehicle mixture. After a rest period of 13 days challenge treatment was carried out with 0.1 % test item mixture (1 : 1 physiological saline and propylene glycol, intradermal injection) as well as with 30 % test item in white vaseline (epicutaneous, occlusive). The patches were removed after 24 h. Another 24 animals served as vehicle control group.
No skin reactions, mortalities or toxic effects could be observed. Therefore, the test item is considered to possess no skin sensitisiing potential to albino guinea pigs.
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