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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessed after consultation with the relevant Authority. Data migrated from NONS files provided by Authority contain insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Remarks:
PHARMACO-LSR LTD. EYE, SUFFOLK IP23 7PX
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:
O9P2V2
IUPAC Name:
divanadium(4+) (phosphonatooxy)phosphonate dioxidandiide
Details on test material:
- Name of test material (as cited in study report): BTN/A
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Primary induction (intradermal): 0.5% w/v in paraffin oil and 0.5% w/v in Freunds Complete Adjuvant
b) Secondary induction (topical): 50% w/v in paraffin oil

Concentration of test material and vehicle used for each challenge:
Primary challenge: 10% in paraffin oil
Secondary challenge: 50% in paraffin oil (separate sites on the right flank of each guinea pig). Challenge on day 22.
Challengeopen allclose all
Route:
other: topical
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Primary induction (intradermal): 0.5% w/v in paraffin oil and 0.5% w/v in Freunds Complete Adjuvant
b) Secondary induction (topical): 50% w/v in paraffin oil

Concentration of test material and vehicle used for each challenge:
Primary challenge: 10% in paraffin oil
Secondary challenge: 50% in paraffin oil (separate sites on the right flank of each guinea pig). Challenge on day 22.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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:
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:
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.
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:
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:
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:
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.

Any other information on results incl. tables

Signs of irritation during induction:

Barely perceptible to moderate erythema with occasional eschar formation or exfoliation.

Evidence of sensitisation of each challenge concentration:

Test group 11/20 at 50% concentration (total response 0/20 at 10% concentration 24-48 hours).

control group 0/20

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
DSD: sensitizing R43
CLP: sensitizing category 1