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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: Conducted according to OECD TG 406 and conducted under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Quinoline, 1,2-dihydro-2,2,4- trimethyl-, homopolymer; identity and stability/homogeneity certified.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: SPF-bred guinea pigs of the strain Hsd Poc:DH
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5%
Topical induction: 50%
Challenge: 12%
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5%
Topical induction: 50%
Challenge: 12%
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
12%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
after induction white wheals and encrustation was observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: after induction white wheals and encrustation was observed.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
12%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

A Guinea Pig Maximization Test (GPMT) according to OECD TG 406 was performed on female guinea pigs. The study was conducted with the following test item concentrations: Intradermal induction: 5% Topical induction: 50% Challenge: 12%. The challenge led to no skin effects in the animals of the treatment group or of the control group. In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits no skin-sensitization potential.