3,5-diethyl-1,2-dihydro-1-phenyl-2-propylpyridine

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:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Principles of method if other than guideline:

This study was conducted at Product Safety Labs in compliance with Good Laboratory Practices as defined in 40 CFR 792; U.S. EPA Good Laboratory Practice Standards; Toxic Substances Control Act (TSCA) and in accordance with Health Effects Testing Guidelines, Subpart E: Primary Dermal Irritation, 40 CFR 798.4470

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Purity 90%, Dark Yellow Liquid, Lot 31018BC

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Number of Animals: 6 (3 males and 3 females), adult rabbits
Initial bodyweights: 1.9-2.1 kg
Received from Davidson's Mill Farm, South Brunswick, NJ

The animals were single housed in suspended stainless steel caging with mesh floors which conform to size recommendations
Litter paper was placed beneath the cage and was changed at least three times per week
Room temperature was kept between 67-75 deg F
12 hour light/dark cycle

Rabbits were given pelleted purina rabbit chow and filtered tap water ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of the test substance

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours, and 7, 10, and 14 days after patch removal

Number of animals:

6

Details on study design:

One the day before application, a group of animals was prepared by clipping the dorsal area and the trunk. After shaving and just prior to application, the animals were weighed, examined for health and the skin checked for any abnormalities. Five tenths of a millileter of the test substance was applied to one 6 cm x 6 cm intact dose site on each animal and covered with a 2 1/4 x 4'' adhesive-backed gauze patch. The patch and entire trunk of each animal were then wrapped with semiocclusive 3' micropore tape to avoid dislocation of the patch. Elizabethan collars were placed on each rabbit and they were returned to their designated cage.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

48 h

Score:

2.5

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Remarks on result:

probability of moderate irritation

Any other information on results incl. tables

Based on the scoring system used, the test material is classified as moderately irritating to the skin when applied as received.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on the scoring system used, the test material is classified as moderately irritating to the skin when applied as received.