Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When the study was conducted, no validated LLNA method was available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Bismuth vanadium tetraoxide
EC Number:
237-898-0
EC Name:
Bismuth vanadium tetraoxide
Cas Number:
14059-33-7
Molecular formula:
Bi O4 V
IUPAC Name:
bismuth vanadium tetraoxide
Details on test material:
- Name of test material (as cited in study report): Mix 1:1 Irgacolor Yellow 14247/Sicopal Yellow L 1100
- Physical state: solid
- Analytical purity: 67.3%
- Lot/batch No.: Irgacolor Yellow 14247: batch No. 262380; Sicopal Yellow L 1100: batch No. 300092

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
5%
Day(s)/duration:
1 week
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50 %
Day(s)/duration:
48 hours
Adequacy of induction:
highest technically applicable concentration used
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50 %
Day(s)/duration:
24 hours
No. of animals per dose:
5 per sex for the test group and 5 of one sex for controls. Additional animals were needed because the first test was inconclusive to give a total of 20 test and 10 control animals.

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
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Body weights were unaffected by the treatment. Under the experimental conditons empoyed, none of the animals of the test group were sensitized 24 and 48 hours after removing the dressings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is regarded as non-sensitizing to albino guinea pigs under the conditions of the study.