Nickel difluoride

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 26,2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not GLP - not enough details on test material

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Internale Guideline from Nipera

Deviations:

not specified

Principles of method if other than guideline:

1) SIMULATED GASTRIC FLUID
Each extraction was performed using 0.1 gram of sample in 50 ml of Simulated Gastric Fluid (pH≤1.5). Samples were weighed into acid washed 250 ml amber Erlenmeyer flasks. Gastric Fluid was added to pH was checked for each solution and adjusted if necessary with 2N HCl.The flasks were covered with parafilm and aluminium foil.The flasks were paklced in a preheated 37°C reciprocal shaker bath.The samples were allowed toshake for the required exctraction times.Once complete, the solutions were removed from the bath.The pH was checked and solution were filtered trough a 0.45 µm filter. The filtrated were collected in 8 oz. disposable plastic bottle and kept in a 35°c incubator until analyzed by EPA method #200.8 (ICP/MS).

2)SIMULATED ALVEOLAR FLUID
Each extraction was performed using 0.1 gram of sample in 50 ml of Simulated Alveolar fluid (pH=7.4 ± 0.2). Sample were weighed into acid washed 250 ml amber Erlenmeyer flasks. Simulated alveolar fluid was added to the flasks and they were then swirled to mix compound and fluid.The ph was checked for each solution and adjusted if necessary with 2N Hcl or 1N NaOH. To keep the exctaction pH at 7.4,5% CO2 in Nitrogen was bubbled and alloed to shake for the required extraction times.Once complete, the solutions were removed from the bath. The pH was checked and solutions were filtered trough a 0.45 µm filter. The filtrates were collected in 8 g disposable plastic bottles and kept in a 35°C incubator until analyzed.

3)Artificial Perspiration
Each extraction was performed using 0.1 gram of sample in 50 ml of Simulated Alveolar fluid (pH=6.5 ± 0.1). Sample were weighed into acid washed 250 ml amber Erlenmeyer flasks. Perspiration was added to the flasks and they were then swirled to mix compound and fluid.The opening of the flasks were covered with parafilm and aluminum foil.The flask were then placed in a preheated 37°C water bath. No shaking was performedOnce the extraction was complete, the solution were removed from bath. The pH was checked and solutions were filtered trough a 0.45 µm filter. The filtrates were collected in 8 oz. disposable plastic bottles and kept in a 35°C incubator until analyzed.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Nickel fluoride (32.18% Nickel)

IUPAC Name:

Nickel fluoride (32.18% Nickel)

Details on test material:

- Name of test material (as cited in study report):nickel fluoride N111B-PTL (32.18% Nickel)
As Nickel is 32.18% of the powder, it is assumed that the starting material is NiF2*4H2O

Radiolabelling:

no

Results and discussion

Any other information on results incl. tables

Simulated Gastric fluid
Extraction time	ug Nickel/ g Sample	% Nickel/ g Sample	% Nickel Release/ Nickel content
2 hours	262.77	26.3	81.7
	267.090 (dup)	26.7	83
5 hours	264.875	26.5	82.3
	270.300 (dup)	27	84
24 hours	261.53	26.1	81.3
	271.390 (dup)	27.1	84.3
72 hours	273.86	27.4	85.1
	282.115 (dup)	28.2	87.7

Simulated Alveolar fluid
Extraction time	ug Nickel/ g Sample	% Nickel/ g Sample	% Nickel Release/ Nickel content
2 hours	116.6	11.7	36.2
	117.100 (dup)	11.7	36.4
5 hours	115.31	11.5	35.8
	131.110 (dup)	13.1	40.7
24 hours	132.015	13.2	41
	129.950 (dup)	13	40.4
72 hours	134.76	13.5	41.9
	136.185(dup)	13.6	42.3

Artificial Perspiration
Extraction time	ug Nickel/ g Sample	% Nickel/ g Sample	% Nickel Release/ Nickel content
2 hours	305.97	30.6	95.1
2 hours	316.535 (dup)	31.7	98.4
5 hours	304.695	30.5	94.7
5 hours	313.545 (dup)	31.4	97.4
24 hours	312.62	31.2	97.2
24 hours	311.220 (dup)	31.1	96.7
72 hours	320.895	32.1	99.7
72 hours	318.27	31.8	98.9