Tris(pentane-2,4-dionato-O,O')vanadium

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

October 1991 - January 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented publication which meets basic scientific principles.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

October 1991 - January 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented publication which meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

For establishing dilutions of vanadium pentoxide for a occupational skin sensitisation study, 100 of the subjects were patch tested with vanadium pentoxide at the concentrations 1, 2 and 10 %.

GLP compliance:

no

Specific details on test material used for the study:

The test material was obtained directly from chemical industries supplying ceramic producers.

Species:

other: human

Details on test animals or test system and environmental conditions:

For establishing dilutions of vanadium pentoxide 100 of the subjects undergoing standard patch testing were patch tested with vanadium pentoxide at the concentrations 1, 2 and 10 %. Patch tests were applied with Finn Chambers (Epitest. Finland) on Scanpor tape (Norgesplaster, Norway) to the healthy skin of the back.

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: petroletum

Controls:

no

Amount / concentration applied:

1, 2 and 10 %

Duration of treatment / exposure:

not specified

Observation period:

not specified

Number of animals:

100 human volunteers

Irritation parameter:

erythema score

Basis:

other: human 1-100

Time point:

other: not specified

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Remarks:

No skin reactions were observed. The time points of observation were not specified.

Irritation parameter:

edema score

Basis:

other: human 1-100

Time point:

other: not specified

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Remarks:

No skin reactions were observed. The time points of observation were not specified.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

No skin reactions to patch tests performed with vanadium pentoxide at different concentrations (1, 2 and 10%) were observed in 100 subjects.

Interpretation of results:

GHS criteria not met

Conclusions:

No skin reactions to patch tests performed with vanadium pentoxide at different concentrations (1, 2 and 10%) were observed in 100 subjects. The results give indication that no skin irritative potential can be attributed to vanadium pentoxide.

Executive summary:

In this study 100 humans were patch tested with vanadium pentoxide at the concentrations 1, 2 and 10 %. No skin reactions were observed. The results give indication that no skin irritative potential can be attributed to vanadium pentoxide.

Data source

Reference

Reference Type:

publication

Title:

Contact dermatitis and contact sensitization among enamellers and decorators in the ceramics industry

Author:

Motolese, A., Truzzi, M, Giannini, A., Seidenari, S.

Year:

1993

Bibliographic source:

Contact Dermatitis 1993: 28: 59-62

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

126 enamellers and 64 decorators from 5 factories underwent dermatological and allergological examination using occupational test series in order to evaluate the prevalence of dermatitis and contact sensitisation, and to identify the most important sensitising substances

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

patch test in human serves as weight-of-evidence

Test material

Test material information

Constituent 1

Reference substance name:

Divanadium pentaoxide

EC Number:

215-239-8

EC Name:

Divanadium pentaoxide

Cas Number:

1314-62-1

Molecular formula:

O5V2

IUPAC Name:

dioxovanadiooxy(dioxo)vanadium

Specific details on test material used for the study:

The test material was obtained directly from chemical industries supplying ceramic producers.

In vivo test system

Test animals

Species:

other: human

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, semiocclusive

Vehicle:

petrolatum

Concentration / amount:

10 %

Challenge

Route:

epicutaneous, semiocclusive

Vehicle:

petrolatum

Concentration / amount:

10 %

Details on study design:

For establishing dilutions of vanadium pentoxide 100 of the subjects undergoing standard patch testing were patch tested with vanadium pentoxide at the concentrations 1, 2 and 10 %.

Positive control substance(s):

no

Remarks:

allergens from different groups of chemical substances

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10 %

No. with + reactions:

1

Total no. in group:

190

Clinical observations:

the sensitised persons represent 0.005 %

Results 2

Group:

positive control

Remarks on result:

not measured/tested

Results 3

Group:

negative control

Remarks on result:

not measured/tested

Any other information on results incl. tables

No skin reactions to patch tests performed with vanadium pentoxide at different concentrations (1, 2 and 10%) were observed in 100 subjects undergoing standard patch testing. Dermatitis was present in 22 workers (11.57 %). whereas 44 subjects (23.15 %) claimed to have had skin lesions in the past. In all subjects, the hands were or had been affected, and in 5 patients the forearms were also involved. 48 workers (corresponding to 25.26 % of the study population) were either mono- (42 subjects) or poly-sensitised (6 subjects), with a total of 55 positive patch tests. Table 2 shows the list of allergens which brought about positive responses. 28 subjects (14.73 % of the total) were positive to nickel sulphate; of these, 17 were women. Furthermore, there were 17 positive reactions to substances specific to the ceramics industry: 7 to red iron oxide; 2 to antimony trioxide, manganese dioxide and maleic anhydride; 1 to red copper oxide, cadmium chloride, vanadium pentoxide and sodium tripolyphosphate.

Table 2. No. sensitisations to substances used in the ceramics Industry in enamellers and decorators

Hapten	Total 190 (100 %)	Enamellers 126 (100 %)	Decorators 64 (100 %)
nickel sulphate	28 (14.7 %)	8 (6.3 %)	20 (31.2 %)
red iron oxide	7	6	1
cobalt chloride	5	2	3
antimonv irioxide	2	1	1
mercapto mix	2	1	1
manganese dioxide	2	1	1
maleic anhydride	2	1	1
potassium diehromaie	1	0	1
red copper oxide	1	1	0
cadmium chloride	1	1	0
carba mix	1	1	0
PPD mix	1	1	0
vanadium pentoxide	1	1	0
sodium tripolyphosphate	1	1	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, 1 out of 190 workers (0.005 % of the test subjects) was positive in patch test to vanadium pentoxide (10 % in petrolatum).

Executive summary:

126 enamellers and 64 decorators from 5 factories underwent dermatological and allergological examination using occupational test series in order to evaluate the prevalence of dermatitis and contact sensitisation, and to identify the most important sensitising substances. 44 workers (corresponding to 25.26 % of the study population) were sensitised, with a total of 55 positive patch tests. Dermatitis was present in 22 workers, whereas 44 subjects claimed to have had skin lesions in the past. 17 positivities to specific substances were observed: 7 to red iron oxide; 2 to antimony trioxide, manganese dioxide and maleic anhydride; and 1 to red copper oxide, cadmium chloride, vanadium pentoxide and sodium tripolyphosphate.

No skin reactions to patch tests performed with vanadium pentoxide at different concentrations (1, 2 and 10 %) were observed in 100 subjects undergoing standard patch testing.

1 out of 190 workers (0.005 % of the test subjects) was positive in patch test to vanadium pentoxide (10 % in petrolatum).