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EC number: 237-769-9 | CAS number: 13981-86-7
- 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:
- 22 May 2019 to 17 July 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines
- Version / remarks:
- 2000 (including the most recent revisions)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig Maximization test was selected since the test material could not be formulated homogenously in the vehicles accepted for the Local Lymph Node Assay as preferred alternative.
Attempts were made to conduct a LLNA on the substance. The testing laboratory performed trial preparations in an attempt to find a suitable vehicle for use in the study. As the substance consists of relatively big chunks the laboratory first ground some of these chunks using a mechanic grinder. The achieved powder was tested in the standard vehicles for LLNA studies: Acetone/Olive oil (4:1 v/v), N,N-dimethylformamide, methylethylketone, propylene glycol, dimethylsulfoxide and 1 % Pluronic© L92 in Elix water. In all these vehicles 50 and 20 % concentrations were tried but the substance settled out at the bottom of the container for each formulation. As such a suitable vehicle could not be found and it was not possible to continue with the LLNA study.
Test material
- Reference substance name:
- Niobium hydride
- EC Number:
- 237-769-9
- EC Name:
- Niobium hydride
- Cas Number:
- 13981-86-7
- Molecular formula:
- HNb
- IUPAC Name:
- niobium(1+) hydride
- Test material form:
- solid
- Details on test material:
- Appearance: Silver grey solid
1
- Specific details on test material used for the study:
- PREPARATION OF TEST MATERIAL
Test material dosing formulations (w/w) were homogenised to visually acceptable levels at appropriate concentrations to meet dose level requirements.
The dosing formulations were kept at room temperature until dosing. The dosing formulations and vehicle were stirred until and during dosing.
No adjustment was made for specific gravity of the vehicle. No correction was made for the purity/composition of the test material.
Any residual volumes were discarded.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known: SPF-Quality
- Age at study initiation: Young adult animals (approximately 5 weeks old) were selected at the start of dosing.
- Weight at study initiation: 344 to 392 g at the start of dosing. Animals were assigned to the study according to body weights, with all animals within ± 20 % of the mean.
- Housing: On arrival and following assignment to the study, animals were group housed (up to 5 animals of the same sex and same dosing group together) in labelled cages (74 x 54 x 25 cm height) containing sterilised sawdust as bedding material equipped with water bottles. For psychological/environmental enrichment, animals were provided with shelters (90 x 5 x 125 mm).
- Diet: Complete maintenance diet for guinea pigs was provided ad libitum. In addition, hay was provided at least twice a week.
- Water: Municipal tap-water was freely available to each animal via water bottles.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 to 23 °C
- Humidity (relative): 42 to 71 %
- Air changes: Ten or greater air changes per hour with 100 % fresh air (no air recirculation) were maintained in the animal rooms
- Photoperiod: A 12-hour light/12-hour dark cycle
IN-LIFE DATES
The in-life phase of the study was completed on 12 July 2019
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Guinea pigs were intradermally injected with a 5 % concentration and epidermally exposed to a 50 % concentration
- Day(s)/duration:
- Intradermal injections were made on day 1 and epidermal exposure took place on day 8
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Challenge took place on day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Experimental group: 10 females
- Control group: 5 females - Details on study design:
- PRELIMINARY IRRITATION STUDY
A preliminary irritation study was conducted in order to select test material concentrations to be used in the main study. The selection of concentrations was based on the following criteria:
- The concentrations are well-tolerated systemically by the animals.
- For the induction exposures: the highest possible concentration that produced mild to moderate irritation (grades 2 - 3).
- For challenge exposure: the maximum non-irritant concentration.
Series of test material concentrations were tested. Practical feasibility of administration determined the highest starting-concentration for each route. The starting and subsequent concentrations were taken from the series: 100 (undiluted), 50, 20, 10, 5, 2 and 1 %.
The test system and procedures were identical to those used during the main study, unless otherwise specified. The four animals selected were between 4 and 9 weeks old. No body weights were determined.
> Intradermal injections
A series of four test material concentrations was tested, the highest concentration being the maximum concentration that could technically be injected. Two animals received two different concentrations in duplicate (0.1 mL/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
> Epidermal application
A series of four test material concentrations was tested, the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using patches (2 x 3 cm) mounted on medical tape which were held in place with micropore tape and subsequently elastic bandage.
The animals receiving intradermal injections were treated with the lowest concentrations and two other animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test material using water. The treated skin areas were assessed for irritation 24 and 48 hours after removal of the dressings.
MAIN STUDY
The concentrations and induction method were selected based on the results of the preliminary irritation study.
> Induction: Experimental animals
- Day 1: The scapular region was clipped and three pairs of intradermal injections (0.1 mL/site) were made in this area as follows:
A) A 1:1 w/w mixture of Freund’s Complete Adjuvant with water for injection.
B) The test material at a 5 % concentration.
C) A 1:1 w/w mixture of the test material, at twice the concentration used in (B) and Freund’s Complete Adjuvant.
- Day 3: The dermal reactions caused by the intradermal injections were assessed for irritation.
- Day 7: The scapular area between the injection sites was clipped and subsequently rubbed with 10 % sodium-dodecyl-sulfate in Vaseline using a spatula. This concentration of SDS provokes a mild inflammatory reaction.
- Day 8: The 10 % SDS treated area between the injection sites was treated with 0.5 mL of a 50 % test material concentration using a patch (2 x 3 cm) mounted on medical tape, which was held in place with micropore tape and subsequently elastic bandage.
The dressing was removed after 48 hours exposure, the skin cleaned of residual test material using water and the dermal reactions caused by the epidermal exposure were assessed for irritation.
> Induction - Control animals
The control animals were treated as described for the experimental animals except that, instead of the test material, the vehicle was administered.
> Challenge - All animals
- Day 21: One flank of each animal was clipped and treated by epidermal application of a 50 % test material concentration and the vehicle (0.1 mL each, using patch test plasters). The patches were held in place with micropore tape and subsequently elastic bandage.
The dressing was removed after 24 hours exposure and the skin cleaned of residual test material and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.
After termination, animals were sacrificed using isoflurane and an intracardial injection of Euthasol® 20 %.
> In-life Procedures, Observations, and Measurements
- Mortality/Moribundity Checks: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from their cage during observation, unless necessary for identification or confirmation of possible findings.
- Toxicity: Observations for toxicity were performed once daily throughout the study.
- Body Weights: Animals were weighed individually on Day 1 (pre-dose) and after the challenge.
- Irritation: Irritation observations were performed according to the following numerical scoring system:
Grading of Irritation Reactions (intradermal reactions will be scored for erythema only or, if necrosis is present, the diameter of necrosis):
Erythema and eschar formation:
No erythema: 0
Slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation:
No oedema: 0
Slight oedema (barely perceptible): 1
Well-defined oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Grading of Challenge Reactions:
No visible change: 0
Discrete or patchy erythema: 1
Moderate and confluent erythema: 2
Moderate erythema and swelling: 3
Intense erythema and swelling: 4
- Terminal Procedures: Necropsy for gross macroscopic examination was not performed. - Challenge controls:
- Two weeks after the epidermal application all animals were epidermally challenged with a 50 % test material concentration and the vehicle.
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
- Positive control results:
- Positive control concentrations selected for this study were:
- Intradermal induction: a 20 % solution in Corn oil.
- Epidermal induction: a 50 % solution in Corn oil.
- Challenge: a 50 % solution in Corn oil.
The skin reactions observed in all experimental animals in response to the 20 % concentration in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results lead to a sensitisation rate of 100 % to the 50 % concentration.
From these results, it was concluded that the female guinea pig of the Dunkin Hartley strain is an appropriate animal model for the performance of studies designed to evaluate the sensitising potential of a test material in a Maximization type of test.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % concentration
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % concentration
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % concentration
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % concentration
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
Any other information on results incl. tables
Preliminary Irritation Study
Based on the results, the test material concentrations selected for the main study were a 5 % concentration for the intradermal induction and a 50 % concentration for the epidermal induction exposure.
No signs of irritation to the highest test material concentration epidermally tested were observed. Therefore, the test site of all animals of the main study were treated with 10 % SDS approximately 24 hours before the epidermal induction, to provoke a mild inflammatory reaction.
A 50 % test material concentration was selected for the challenge phase.
Main study
> Induction Phase: The reactions noted in the experimental and control animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment.
> Challenge Phase: No skin reactions were evident after the challenge exposure in the experimental and control animals.
> Toxicity / Mortality: No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
> Body Weights: Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Table 1: Induction Readings for Control Animals
Animal Number |
Intradermal injections (readings Day 3) |
Epidermal exposure (readings Day 10) |
||||||
1:1 Mixture of FCA and water for injection |
Vehicle |
1:1 Mixture of FCA and vehicle |
Vehicle |
|||||
Erythema |
Signs of necrosis (Ø mm) |
Erythema |
Signs of necrosis (Ø mm) |
Erythema |
Signs of necrosis (Ø mm) |
Erythema |
Oedema |
|
21 |
2 |
|
0 |
|
1 |
|
0 |
0 |
22 |
|
3 |
0 |
|
|
2 |
0 |
0 |
23 |
2 |
|
1 |
|
1 |
|
0 |
0 |
24 |
|
2 |
1 |
|
2 |
|
0 |
0 |
25 |
|
2 |
1 |
|
|
2 |
0 |
0 |
Table 2: Induction Readings for Experimental Animals
Animal Number |
Intradermal injections (readings Day 3) |
Epidermal exposure (readings Day 10) |
||||||
1:1 Mixture of FCA and water for injection |
5 % Test Material Concentration |
1:1 Mixture of FCA and a 10 % Concentration |
50 % Test Material Concentration |
|||||
Erythema |
Signs of necrosis (Ø mm) |
Erythema |
Signs of necrosis (Ø mm) |
Erythema |
Signs of necrosis (Ø mm) |
Erythema |
Oedema |
|
26 |
|
2 |
1 |
|
1 |
|
0t |
0 |
27 |
|
1 |
1 |
|
2 |
|
0t |
0 |
28 |
|
1 |
1 |
|
|
1 |
0t |
0 |
29 |
2 |
|
2 |
|
2 |
|
0t |
0 |
30 |
2 |
|
1 |
|
2 |
|
0t |
0 |
31 |
1 |
|
1 |
|
2 |
|
0t |
0 |
32 |
|
2 |
2 |
|
|
2 |
0t |
0 |
33 |
|
1 |
1 |
|
1 |
|
0t |
0 |
34 |
2 |
|
1 |
|
|
1 |
0t |
0 |
35 |
|
1 |
1 |
|
|
1 |
0t |
0 |
t: Grey staining of the skin, caused by staining properties of the test material
Table 3: Challenge Readings
Animal number |
Day 23 |
Day 24 |
Comments |
||
Test material concentration 50 % |
Vehicle |
Test material concentration 50 % |
Vehicle |
||
Control |
|||||
21 |
0 |
0 |
0 |
0 |
Not sensitised |
22 |
0 |
0 |
0 |
0 |
Not sensitised |
23 |
0 |
0 |
0 |
0 |
Not sensitised |
24 |
0 |
0 |
0 |
0 |
Not sensitised |
25 |
0 |
0 |
0 |
0 |
Not sensitised |
Experimental |
|||||
26 |
0 |
0 |
0 |
0 |
Not sensitised |
27 |
0 |
0 |
0 |
0 |
Not sensitised |
28 |
0 |
0 |
0 |
0 |
Not sensitised |
29 |
0 |
0 |
0 |
0 |
Not sensitised |
30 |
0 |
0 |
0 |
0 |
Not sensitised |
31 |
0 |
0 |
0 |
0 |
Not sensitised |
32 |
0 |
0 |
0 |
0 |
Not sensitised |
33 |
0 |
0 |
0 |
0 |
Not sensitised |
34 |
0 |
0 |
0 |
0 |
Not sensitised |
35 |
0 |
0 |
0 |
0 |
Not sensitised |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was determined not to be a sensitiser in the guinea pig maximisation test.
- Executive summary:
The purpose of this study was to evaluate whether the test material induces contact hypersensitivity in guinea pigs after intradermal and epidermal exposure in accordance with the standardised guidelines OECD 406, EU Method B.6, US EPA OPPTS 870.2600 and JMAFF Guidelines (2000). The study was conducted under GLP conditions.
Test material concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten female Dunkin Hartley guinea pigs were intradermally injected with a 5 % concentration and epidermally exposed to a 50 % concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10 % SDS. Two weeks after the epidermal application all animals were epidermally challenged with a 50 % test material concentration and the vehicle.
There was no evidence that the test material had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50 % test material concentration in the challenge phase. This result indicates a sensitisation rate of 0 per cent.
Under the conditions of this study, the test material was determined not to be a sensitiser in the guinea pig maximisation test.
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