Phenylephrine hydrochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pseudoephedrine hydrochloride

EC Number:

206-462-1

EC Name:

Pseudoephedrine hydrochloride

Cas Number:

345-78-8

IUPAC Name:

2-(methylamino)-1-phenylpropan-1-ol hydrochloride

Details on test material:

- Name of the test substance : (+)-pseudoephedrin-hydroclorid
- Test substance No.: 85 / 415

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main FRG
- Housing: Individually in stainless steel cages with wire mesh walk floors (floor area: 40 cm x 51 cm). No bedding in the cages; sawdust in the waste trays.
- Weight at study initiation: Males: 3.03 kg, Females: 3.24 kg
- Diet: Kliba 341, 4 mm, Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (About 130g per animal per day)
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

0.5 gram

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 males and 1 female)

Details on study design:

Two male and 1 female rabbit were clipped at least 15 hours before treatment. The upper third of the back or flanks were used (approximately 2.5 x 2.5 cm). The test patch is covered with an layer of about 0.5 mm of the 80% (w/w) aqueous suspension. Test patches are secured in position with a porous dressing of four layers of absorbent gauze and a layer of porous bandage. After the exposure period of 4 hours the skin was washed with lutrol and lutrol/water (1:1). Readings were performed 30-60 minutes after patch removal and 24, 48, and 72 hours after application. Clinical signs of necrosis were confirmed by gross pathological examination after incision of the skin.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 + 48 + 72 hours after application

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 + 48 + 72 hours after application

Score:

0

Max. score:

4

Irritant / corrosive response data:

After the removal of the patch, well defined erythema and slight edema (both beyond the area of exposure) was observed in one male rabbit. In the other rabbits slight erythema was observed and also slight edema was observed in the female rabbit at this time point. All effects were fully reversible as no effects were seen in the rabbits at the other time points.