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EC number: 247-019-2 | CAS number: 25481-21-4
- 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
Endpoint summary
Administrative data
Description of key information
No dermal reactions were observed at 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine the allergenic potential of the test chemical in guinea pigs
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- no data available
- Route:
- other: intracutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- First day 0.1 ml, then 0.2 ml on alternate days
- Day(s)/duration:
- 10 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: intracutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5 male
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 10 days
- Test groups: 5
- Control group: no data available
- Site: no data
- Frequency of applications: First day 0.1 ml, then 0.2 ml on alternate days
- Duration: First day 0.1 ml, then 0.2 ml on alternate days
- Concentrations: First day 0.1 ml, then 0.2 ml on alternate days
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 2 weeks after last induction injection
- Exposure period: 24 hours
- Test groups: 5
- Control group: no data
- Site:
- Concentrations: 0.1 ml
- Evaluation (hr after challenge): 24 hours later - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
- Executive summary:
The allergenic potential of the test chemical was determined in guinea pigs. 5 male guinea pigs were injected intra cutaneously with a volume of 0.1 ml of the test chemical on day 1, then 9 volumes of 0.2 ml of the test chemical on alternate days.
2 weeks after last induction injection, the guinea pigs were challenged with 0.1 ml of the test chemical via intracutaneous injection. The sites were evaluated 24 hours later for signs of dermal sensitization.
No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the closely related chemicals, the weight of evidence approach was applied to assess the dermal sensitization potential of the nickel(II) EDTA complex.
Study 1 :
The allergenic potential of the test chemical was determined in guinea pigs. 5 male guinea pigs were injected intra-cutaneously with a volume of 0.1 ml of the test chemical on day 1, then 9 volumes of 0.2 ml of the test chemical on alternate days. 2 weeks after last induction injection, the guinea pigs were challenged with 0.1 ml of the test chemical via intracutaneous injection. The sites were evaluated 24 hours later for signs of dermal sensitization. No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
Study 2 :
The study was conducted to determine the dermal sensitivity of test chemical. Male Hartley guinea pigs (10/group) were used for the study.Diglycidyl ether of 2,2-di(p,p’-hydroxyphenyl)propane was used as the positive control. The test chemical was applied topically as 10% solutions in Dipropylene glycol methyl ether and Polysorbate80(9:1). 0.1 ml of the test solutions were applied topically to the depilated, clipped backs of the guinea pigs, four times in 10 days. At the third application, 0.2 ml of Freund's adjuvant was injected intradermally adjacent to the application site. The guinea pigs were topically challenged on clipped flanks 2 weeks after the fourth treatment. The treatment sites were examined for irritation and sensitization at 24 and 48 hours after challenge exposure. Skin sensitization was observed in the group treated with the test chemical. Hence, the test chemical was considered to be not sensitizing to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the closely related substances indicate that Nickel(II) EDTA complex is non sensitizer.
Hence by applying the weight of evidence approach using read across substance data, Nickel(II) EDTA complex can be considered to be not sensitizing to skin.
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