Registration Dossier
Registration Dossier
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EC number: 200-076-7 | CAS number: 51-03-6
Skin sensitisation
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:
- 2 007
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
- Reference substance name:
- Piperonyl butoxide
- IUPAC Name:
- Piperonyl butoxide
- Details on test material:
- Piperonyl butoxide (PBO)
Constituent 1
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.
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