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Diss Factsheets

Administrative data

Description of key information

Non-sensitising in a Buehler assay in guinea pigs

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
This study was according to the OECD 406 Buehler protocol
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Predates OECD 429, LLNA
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
28 young adult Hartley Guinea Pigs were used in the study. 14 males and 14 females were used.
Animals were purchased from a registered commercial breeding laboratory (Elm Hill Breeding Labs, Chelmsford, MA)
All animals weighed between 250-400 grams before the test study
All animals were between 21-43 days old
Animals were housed in stainless steel cages
Test rooms were held at 68±F with an average humidity of 30-70%
A 12 hour light/dark cycle was used within the lab room, and 10-13 air changes per hour occured

All test animals received food and water ad libitum
Animals were supplied with a diet of guinea pig ration and municiple tap water
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
10%, 25%, 50%, and 100% at 0.4 mL
Day(s)/duration:
6 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
50% concentration, 0.4 mL
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
4
Details on study design:
The Buehler closed patch technique was used to test guinea pigs for signs of skin sensitisation.
Positive control substance(s):
yes
Remarks:
DNCB
Positive control results:
DNCB
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
4
Total no. in group:
4
Remarks on result:
positive indication of skin sensitisation

In a preliminary irritation screening study and during the induction phase of main study, signs of erythema or edema were observed in animals at concentrations of 100%. The irritation was transient and disappeared within 48 h. No erythema or edema were observed when animals were challenged with 50% concentrations. The test substance was not considered a skin sensitizer.

Interpretation of results:
GHS criteria not met
Conclusions:
4-Phenylpropylpyridine was not considered a skin sensitizer in guinea pigs in a Buehler procedure for dermal sensitisation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A Buehler sensitisation study was undertaken in guinea pigs with 4-PPP, at induction concentrations up to 100% and challenge concentration of 50%. No dermal sensitisation was observed. The substance does not meet the criteria for dermal sensitisation of Regulation EC No. 1272/2008. It is not classified.