Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Piperonyl butoxide
IUPAC Name:
Piperonyl butoxide
Details on test material:
Piperonyl butoxide (PBO)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: sesame oil
Concentration / amount:
Intracutaneous induction: 10%
topical induction: undiluted
Topical challenge: 50%
Challengeopen allclose all
Route:
other: dermal
Vehicle:
other: sesame oil
Concentration / amount:
Intracutaneous induction: 10%
topical induction: undiluted
Topical challenge: 50%
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period:
- Test groups:10 females
- Control group:5 females
- Site:
- Frequency of applications:
- Duration:
- Concentrations:

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:1
- Exposure period:24 h
- Test groups:10 females
- Control group:15 females
- Site:
- Concentrations: 50%
- Evaluation (hr after challenge): 24h

OTHER:
Positive control substance(s):
yes
Remarks:
parallel test with benzocaine

Study design: in vivo (LLNA)

Statistics:
not required

Results and discussion

Positive control results:
Animals of this strain treated with benzocaine in 40% ethanolic 0.9% NaCI solution exhibited a sensitising reaction in all animals in form of a discrete or patchy erythema (grade 1) or a moderate and confluent erythema (grade 2).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
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: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
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: 5.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not a skin sensitiser.
Executive summary:

In a dermal sensitization study PBO in sesame oil was tested in a group of young Dunkin-Hartley guinea pigs using the method of Magnusson and Kligman. Benzocaine in a parallel served as positive control material. No signs of systemic toxicity were noted.

No skin sensitization was induced by the test material. In this study, Piperonyl butoxide was not a dermal sensitiser.