4-(3-phenylpropyl)pyridine

Skin irritation / corrosion

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Administrative data

Endpoint:

skin irritation: in vivo

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:

other: US OSHA: 16 CFR 1500.41

Principles of method if other than guideline:

Protocol according to U.S. FHSA: occlusive exposure of intact and abraded skin for 4 hours.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Yellowish Brown Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals for this test were subjected to no other experimentation prior to the study. Animals selected were obtained from a larger pool of other animals and were examined to ensure that their skin was free from irritation, trauma, and disease.
They were sourced from Eastern Rabbit Breeding Laboratories, Taunton, MA, USA. They weighed 2-3 kg at the start of the study and were 10-12 weeks of age.
Animals were housed individually using suspended stainless steel cages. Hardwood chips were used for non-contact bedding under the cages.
Animal rooms were maintained at 68±3 deg. F, with Humidity maintained at 30-70%. A 12 hour light/dark cycle was used

All animals were supplied with a commerical rabbit ration and municiple tap water ad libitum.
Upon receipt, all animals were housed in quarantine for a period of 4 days under the same conditions as the actual test.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The test material applied was introduced under a guaze pad two layers thick, measuring 2.5cm x 2.5cm, which were held together by an impervious (occlusive) bandage.

Duration of treatment / exposure:

Skin was exposed to the test material for a 4 hour period

Observation period:

After test material was removed, the test sites were monitered for signs of irritation at 24 and 72 hours.

Number of animals:

3 males and 3 females.

Details on study design:

Test and control sites of each rabbit were clipped of all hair around the trunk.
One application site of each animal was abraded by making minor incisions through the stratum corneum, but not sufficient enough to disturb the derma.The second application site was intact skin.
The animals were treated by introducing the test substance to the skin using a gauze pad 2.5 cm x 2.5 cm, and was held together by an impervious bandage.
The test material was held to the skin for a period of four hours before it was removed and cleaned of any excess material.
Each animal served as its own control (untreated site).
At the end of the study (72 h after application), the animals were weighed and euthanised with a barbiturate (Euthanasia-5, Verterinary Labortories Inc., Topeka, KS).

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

8

Reversibility:

not specified

Remarks on result:

no indication of irritation

Any other information on results incl. tables

None of the test sites of any animal at any time during the study showed signs of erythema or edema, whether the skin was abraded or intact.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was found to be non-irritating to the skin of New Zealand Rabbits after occlusive exposure of intact and abraded skin to 4-phenylpropylpyridine for 4 hours.