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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
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
1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Crl:WI Wistar rats (from SPF colony) were obtained from Charles River Laboratories, Research Models and Services, Germany GmbH (Sandhofer Weg 7,
D-97633 Sulzfeld, Germany).
After arrival, the animals’ health was certified by the Veterinarian.
Species and strain: Crl:WI Wistar rats
Hygienic level: SPF at arrival, standard housing conditions during the study
Number of animals: Sighting Exposure: 1 animal/sex
Main Study: 5 animals/sex
Sex: Male and female, females: non-pregnant and nulliparous
Age and body weight range of animals on the exposure day (Day 0) were:
Sighting Exposure: 8 weeks old, 314 g (males) and 217 g (females)
Main Study: 9 weeks old, 348-372 g (males) and 240-252 g (females
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- ca. 3.04 - ca. 3.59 µm
- Geometric standard deviation (GSD):
- ca. 2.42
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.02 - 5.06 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- guideline study
- Statistics:
- Data were collected using the software PROVANTIS v.10 or were recorded on data collection sheets taken from the relevant SOPs, then tabulated using PROVANTIS v.10, Microsoft Office Word and/or Excel, as appropriate.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- ca. 5.02 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- none
- Clinical signs:
- irregular respiration
- Remarks:
- laboured breathing (slight), fur staining by test item (red, on the cranium, face and whole body) and wet fur (generalized) were observed, but the breathing symptoms could be observed on Days 0-1 only.
- Body weight:
- no effects
- Gross pathology:
- no effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality occurred when exposed to a test atmosphere concentration of 5.02 mg/L as a maximum achievable concentration for 4 hours. The acute inhalation median lethal concentration (LC50) of PV Fast Orange 6RL in male and female Crl:WI rats was therefore considered to be above 5.02 mg/L
- Executive summary:
Crl:WI Wistar strain rats were exposed to test atmosphere of PV Fast Orange 6RL at the target concentration of 5 mg/mL. An atmosphere was generated from the test item as supplied.
A Sighting Exposure was performed first; the target concentration (5 mg/L) was tested on one animal each of both sexes (Group 0.1).
Based on the results of the Sighting Exposure (Group 0.1), the Main Study was performed at the target concentration (5 mg/L). Five male and five female rats were used in the Main Group (Group 1).
In the study, the animals were exposed to the test atmosphere for 4 hours using a nose-only exposure system. Aerosol concentration was measured gravimetrically
17 times during each 4-hour exposure. The particle size distribution of the test aerosol was determined 3 times. The day of exposure was designated as Day 0 followed by a 14-day observation period.Clinical observations were performed on all animals during exposure at hourly intervals, following removal from restraint, approximately 1 hour after exposure, and daily for 14 days thereafter. Body weight was measured on Days 0 (before the exposure), 1, 3, 7 and 14. Gross necropsy was performed on all animals on Day 14.
No control group was exposed in this study.
The quality of the test atmosphere fully complied with criteria documented in the respective guidelines: OECD 403, EPA OPPTS 870.1300 and Council Regulation (EC) No 440/2008.
The mean achieved atmosphere concentrations in the study were 5.06 and 5.02 mg/L in Group 0.1 and Group 1, respectively. The mass median aerodynamic diameters (MMAD) were 3.59 and 3.04 µm with geometric standard deviations (GSD) of 2.42 and 2.61 in Group 0.1 and Group 1, respectively.
Summary of the test atmosphere parameters
Group Number
Target Concentration
(mg/L)Mean Achieved Concentration
(mg/L)Standard Deviation of Achieved Concentration (mg/L)
MMAD (µm) / GSD
Sighting Exposure
0.1
5
5.06
0.17
3.59 / 2.42
Main Study
1
5
5.02
0.16
3.04 / 2.61
Mortality
No mortality occurred during the study.
Clinical observations
Sighting Exposure (Group 0.1 - 5.06 mg/L)
Laboured breathing (slight to moderate), abnormal breathing sounds, red fur staining (by test item, on the cranium, generalized) and wet fur (generalized) were observed. Fur staining was observed during the whole observation period but the breathing symptoms were observed on Day 0 only.
Main Group (Group 1 - 5.02 mg/L)
In the male animals, laboured breathing (slight), fur staining by test item (red, on the cranium, face and whole body) and wet fur (generalized) were observed, but the breathing symptoms could be observed on Days 0-1 only.
In the female animals, laboured breathing (slight), fur staining by test item (red, on the cranium, face and whole body) and wet fur (on the whole body) were observed, but the breathing symptoms could be observed on Days 0 only.
Wet fur and fur staining in the animals were considered to be related to the restraint and exposure procedures but not to be toxicologically significant.
Summary of acute inhalation toxicity
Group Number
Mean Achieved Concentration
(mg/L)Toxicological Result*
Onset and Duration of Toxicological Clinical Signs (Day)
Occurrence of Mortality
(Day)Sighting Exposure
0.1
5.06
0/ 2/ 2
0
-
Main Study
1
5.02
0/ 10/ 10
0-1
-
* 1st = number of dead animals, 2nd = number of animals with signs, 3rd = number of animals exposed
Body weight
Sighting Exposure (Group 0.1 – 5.05 mg/L)
In one male animal, slight body weight loss was noted on Days 0-1. The body weight gain was normal between Days 1-14.
Main Group (Group 1 – 5.02 mg/L)
Slight body weight loss was recorded on Days 0-1. The body weight gains were normal afterwards.
Necropsy
There was no evidence of any test item-related gross changes at necropsy in any animal.
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