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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-10-1
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted to internationally recognised test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Vanadyl pyrophosphate
EC Number:
406-260-5
EC Name:
Vanadyl pyrophosphate
Cas Number:
58834-75-6
Molecular formula:
V2P2O9
IUPAC Name:
divanadium(4+) (phosphonatooxy)phosphonate dioxidandiide
Details on test material:
- Name of test material (as cited in study report): BTN/A
- Chemical name: Vanadyl pyrophosphate
- Chemical formula: (VO)2P207
- Relative molar mass: 307.8
- Physical state Fine, dark-brown powder
- Lot/batch No.:0003
- Purity: Vanadium - 30.1%, phosphorous 21.0% by weight
- Storage condition of test material: Cool, dry, well ventilated room

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Olac Ltd, Bicester, England
- Age at study initiation: Not stated
- Weight at study initiation: 336 - 436 g
- Housing: Up to 5 animals/cage; stainless steel grid-bottomed cages
- Diet (e.g. ad libitum): FD1 guinea pig diet from SDS Ltd, Witham , Essex, ad libitum
- Water (e.g. ad libitum): Municipal tap water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1990-04-10 To: 1990-05-18

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction - injection: 0.5% w/v
Induction - Epicutaneous: 50% w/v
Challenge - Epicutaneous: 10 and 50% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction - injection: 0.5% w/v
Induction - Epicutaneous: 50% w/v
Challenge - Epicutaneous: 10 and 50% w/v
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Details on study design:
Selection of main study treatment regimes.
The concentrations chosen for use in induction and challenge were based on preliminary screens.

Constitution of main study groups
The test and control groups each consisted of twenty animals, evenly divided by sex. The control animals were treated identically to the test group during the induction and challenge procedures, except that during induction the test material was replaced by vehicle

Induction procedures
The induction procedures were primary induction by intradermal injection on Day 1 and secondary induction by occluded topical application on Day 8. Dermal responses to primary and secondary induction were assessed approximately 24 hours and 48 hours after injection or removal of the occlusive dressings.
Primary induction
Three pairs of injections (0.1 mL) were made deep into the dermis, such that on either side of the dorsal median line there were three injection sites in a row parallel to the spinal column. All injection sites lay near the periphery of a dermal test site 4 cm x 2 cm long, overlying the scapulae. The anterior and middle sites were positioned close together and distant from the posterior sites.
Secondary induction
On Day 8 the dermal areas treated on Day 1 were treated by topical application of 0.6 mL 50% w/v BTN/A in paraffin oil in test animals while controls received 0.6 ml of paraffin oil. Each dose was absorbed onto a 4 x 2.5 cm absorbent patch (Whatman No. 3 filter paper) which was applied to the skin and covered by an occlusive dressing (Blenderm, 3-M Co. and Elastoplast, Smith and Nephew Ltd) for 48 houres.

Challenge procedure
Both flanks of all animals were clipped to expose areas (5 x 5 cm) on either side of the trunk. On Day 22, the left site was treated by topical application of 0.03 mL paraffin oil while the right side received 0.03 mL 50% /v BTN/A in paraffin oil to one site and 10% w/v BTN/A in paraffin oil to a second site. The doses were absorbed onto 1 cm diameter absorbent patches and covered by an occlusive dressing for 24 hours.
The challenge sites were examined approximately 24 and 48 hours after removal of the occlusive dressings. The presence or absence of erythema or swelling of the treated skin was assessed without knowledge of the number or group identity of the animal under examination. The degree of reaction was scored on a five point scale:
o No response
+/- Barely perceptible erythema
I Slight erythema
2 Moderate erythema
3 Severe erythema

Bodyweight
The bodyweight of each animal was recorded at weekly intervals to detect treatment-related depression of growth or individual cases of ill-health.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A total of eleven of the twenty test animals challenged with 50% w/v BTN/A in paraffin oil displayed a significant response (slight erythema or more marked reaction). No significant reaction was observed in similarly challenged controls nor amongst test or control animals challenged with 10% w/v BTN/A in paraffin oil or paraffin oil alone. It is therefore concluded that, under the conditions of this study, repeated administration of BTN/A caused delayed contact hypersensitivity in guinea-pigs.
Executive summary:

Delayed dermal sensitisation has been investigated using the Maximisation test of Magnusson and Kligman and following OECD/EU test methods. 55% of animals challenged with the substance at a concentration of 50% w/v displayed a significant response. No such reaction was observed in similarly challenged controls. No significant response was observed amongst test or control animals challenged with the substance at a concentration of 10% w/v. It was concluded that the substance causes delayed contact hypersensitivity in guinea-pigs.