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Description of key information

Non-irritating in in vivo testing

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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.

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).
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

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.

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: 29 CFR 1910-1200 and 16 CFR 1500.41
Principles of method if other than guideline:
The test was conducted based on US OSHA, 29 CFR, 1910.1200 and 16 CFR 1500.41
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six healthy, young adult, 3 male and 3 female rabbits were used in the study.
Animals were purchased from a registered commercial breeding laboratory (Eastern Rabbit Breeding Laboratory, Taunton, MA)
Animals weighed between 2.0-3.0 kg
Animals were individually housed in seperate suspended cages.
Rooms were maintained at 68 degrees F.
12 hour dark/light periods were provided.
Animals were supplied with commercial rabbit ration and tap water ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.1 mL was administered to each animal
Duration of treatment / exposure:
Animals were checked for signs of irritation 24 hours after the substance was applied to the eye, and the eye was rinsed of any leftover test material.
Observation period (in vivo):
Observation occured 24 hours after application of substance
Duration of post- treatment incubation (in vitro):
After observation at 24 hours, the eyes were checked again at 48 and 72 hours.
Number of animals or in vitro replicates:
6 total animals were used in the study
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
6
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation

One of the six rabbits was shown to have a positive conjunctival erythema result. The test substance is considered non-irritating to the eyes.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was tested in an eye irritation assay in rabbits and found to be non-irritating.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Testing with rabbits using standard protocols for skin irritation and skin corrosion resulted in findings that 4-PPP is not an irritant. It was also found not be an eye irritant in rabbits. This contrasts with observations from the irritation screening of the dermal sensitisation study in guinea pigs that undiluted 4-PPP resulted in mild skin irritation. The irritation testing results in a standard species carry greater weight; hence the substance is evaluated as non-irritating to the skin and eye.

Justification for classification or non-classification

The substance is not irritating to the eye or skin. It does not meet the criteria for classification according to Regulation EC No. 1272/2008.