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Toxicological information

Skin sensitisation

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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:
other: Study is done similar to OECD guideline 406.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Contact sensitivity to quinidine sulfate from occupational exposure.
Author:
Wahlberg, J.E. and Boman, A.
Year:
1981
Bibliographic source:
Contact Dermatitis 7(1):27-31

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Guinea pig maximisation test as described by Magnusson Kligman (1969, 1970) was used, under the same conditions as reported earlier (Wahlberg and Boman, 1978)
Principles of method if other than guideline:
Guinea pig maximisation test as described by Magnusson Kligman (1969, 1970) was used. At intradermal induction 0.25 % of the drug in distilled water was used. At epicutaneous induction 20 % of the drug in petrolatum was used with previous SLS treatment. Challenge is by topical application. Provided there is no irritation. Challenge testing was performed on day 21 with 1, 5, and 10 % of the drugs in petrolatum. The chambers were left on the animals for 24 h. The challenge site is evaluated 24 hours and 48 hours after removal of the patch. The statistical method was chi-squared analysis.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Reference to existing study (guinea pig maximization test). Additional animal testing is not considered necessary.

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): quinidine sulphate

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: water and petrolatum
Concentration / amount:
intradermal induction: 0.25 % of the drugs in distilled water, epicutaneous induction: 25 % of the drugs in petrolatumChallenge testing was performed on day 21 with 1, 5 and 10 % of the drugs in petrolatum.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: water and petrolatum
Concentration / amount:
intradermal induction: 0.25 % of the drugs in distilled water, epicutaneous induction: 25 % of the drugs in petrolatumChallenge testing was performed on day 21 with 1, 5 and 10 % of the drugs in petrolatum.
No. of animals per dose:
20
Details on study design:
MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 1- Test groups: 20- Control group: 19- Concentrations: 0.25 % intradermal induction, 25 % epicutaneous inductionB. CHALLENGE EXPOSURE- No. of exposures: 1- Test groups: 20- Control group: 19- Day(s) of challenge: on day 21- Concentrations: 10 %, 5 % and 1 % of the drugs in petrolatum- Exposure period: 24h - other: readings were taken 24 h and 48h after removal of the test chambers
Challenge controls:
19 control animals which get 1 %, 5 % and 10 % of the drugs in petrolatum
Positive control substance(s):
no

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:
19
Clinical observations:
no data
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: 19.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
no data
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: 19.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
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. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 %
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
Total no. in group:
19
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
no data
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: 19.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
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. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 %
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Quinidine is a potent contact allergen.
Executive summary:

The contact sensitivity to quinidine sulphate was experimentally determined in guinea pigs. Quinidine sulphate was found to be a grade V allergen according to Magnusson et al., 1969. 100% of the animals reacted to 10 % or 5 % of quinidine sulphate and 40 % of the animals reacted to 1 % of quinidine sulphate after 48 h. 95 % of the animals reacted to 10 % quinidine sulphate and 90 % of the animals reacted to 5 % quinidine sulphate after 24 h. 30 % of the animals reacted to 1 % quinidine sulphate after 24 h. The control animals showed no reaction after 24 h and 48 h. Quinidine is obviously a potent contact allergen and has to be classified.