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Skin sensitisation

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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

Constituent 1
Chemical structure
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)

Resultsopen allclose all
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 %
Group:
positive control
Remarks on result:
not measured/tested
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).