Molybdenum nickel tetraoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 May - 23 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU-Method B.46 (in vitro skin irritation: reconstructed human epidermis model test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD guideline for the testing of chemicals. Draft proposal for a new guideline. In vitro skin irritation: human skin model test, December, 2007

Deviations:

yes

Remarks:

Interleukin-1 alpha was not determined

Principles of method if other than guideline:

The skin irritancy potenial of nickel hydrogencitrate was tested by using the human skin model EPISKIN and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt.

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Molybdenum nickel tetraoxide

EC Number:

238-034-5

EC Name:

Molybdenum nickel tetraoxide

Cas Number:

14177-55-0

Molecular formula:

MoO3*nNiO (with n in a range of 0.6 - 1)

IUPAC Name:

Reaction mass of molybdenum oxide and nickel oxide

Constituent 2

Reference substance name:

238-034-0

IUPAC Name:

238-034-0

Details on test material:

- Name of test material (as cited in study report): Molybdenum nickel tetraoxide
- Molecular formula: NiMoO4
- Physical state / appearance: light yellow powder
- Analytical purity: >99%
- Lot/batch No.: GRA20100315
- Expiration date of the lot/batch: Feb 2012
- Storage conditions: Room temperature 20 +/- 5°C

Test animals

Species:

other: in vitro test: human skin

Strain:

other: in vitro test: human skin

Test system

Type of coverage:

other: in vitro test: human skin model test

Preparation of test site:

other: in vitro test: human skin model test

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Tissue 1: 26.6 mg; Tissue 2: 25.7 mg; Tissue 3: 24.6 mg
and wetted with 25 µL DPBS (Dulbecco's Phophate Buffered Saline) buffer

Duration of treatment / exposure:

not applicable: see "any other information on materials and methods"

Observation period:

not applicable: see "any other information on materials and methods"

Number of animals:

not applicable: see "any other information on materials and methods"

Details on study design:

not applicable: see "any other information on materials and methods"

Results and discussion

In vivo

Irritant / corrosive response data:

Under the experimental conditions, the test item was not irritating to skin.

Any other information on results incl. tables

Table 1: Absorption Values negative control, test item and positive control (Optical Density at 570 nm)

Designation	Measurement	Negative Control	Molybdenum nickel tetraoxide	Positive Control
Tissue 1	1	1.579	1.813	0.210
	2	1.788	1.817	0.218
Tissue 2	1	1.769	1.970	0.184
	2	1.596	1.972	0.187
Tissue 3	1	1.724	2.026	0.222
	2	1.203	1.773	0.234

Table 2: Mean absorption Values (subtracting the blank)

Designation	Negative Control	Molybdenum nickel tetraoxide	Positive Control
Mean – blank (Tissue 1)	1.614	1.745	0.144
Tissue 2	1.613	1.901	0.116
Tissue 3	1.394	1.830	0.158
Mean of three Tissues	1.540	1.825	0.139
Relative Standard Deviation of the three tissues	8.2%	4.3%	15.4%

Table 3: % Formazan Production

Designation	Molybdenum nickel tetraoxide	Positive Control
% Formazan production (Tissue 1)	113.3%	9.4%
% Formazan production (Tissue 2)	123.4%	7.5%
% Formazan production (Tissue 3)	118.8%	10.3%
% Formazan production Mean	118.5%	9.0%

Table 4: Validity

Criterion	Demanded	Found
OD of negative control	between 1.0 and 2.5	1.540
% Formazan production of positive control	<20% of negative control	9.0%
Variation within replicates (RSD)	<18%	8.2% (negative control) 15.4% (positive control) 4.3% (test item)

For the test item 118.5% Formazan production (mean of three tissues) were calculated in comparison to the negative control.

This value is well above the threshold for irritancy of 50%.

For the positive control 9.0% Formazan production (mean of three tissues) were calculated in comparison to the negative control.

Values for negative control and for positive control were within the range of historical data of the test facility. The test item Molybdenum nickel tetraoxide is considered not irritant using this in vitro test with a skin model. Therefore, prediction in- vivo is "not irritant" following the proposals of the guideline.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information