4-(3-phenylpropyl)pyridine

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

Study period:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Yellowish Brown Liquid

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

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

Challenge

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

Results and discussion

Positive control results:

DNCB

In vivo (non-LLNA)

Results

Results 1

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

Results 2

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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.