Pseudoephedrine hydrochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

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other: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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

no

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

Molecular formula:

C10H15NO.ClH

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): (+)-Pseudoephedrine hydrochlorid

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, Germany
- Weight at study initiation (mean): 3.03 kg (Males), 3.24 kg (female)
- Housing: single housing in stainless steel cages wire mesh walk floors. No bedding in the cages
- Diet: Kliba-Labordiaet 341, 4mm; Fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, (about 130 g per day)
- Water: about 250 mL per day
- Acclimation period: at least 8 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: untreated skin of the animal

Amount / concentration applied:

Concentration: 80 %
Amount: about 0.5 g

Duration of treatment / exposure:

4 hour(s)

Observation period:

72 h

Number of animals:

2 males, 1 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
- Type of wrap if used: test patches are secured in position with a porous dressing (four layers of absorbent gauze +porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight to well-defined erythema after 4 h in all animals, but reversible within 24 h. Very slight edema in 2/3 animals after 4 h, but reversible within 24 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Based on the conditions of the performed skin irritation/corrosion test the substance is considered to be not irritating.

Executive summary:

In a skin irritation/corrosion test according to OECD guideline 404, 2 male and 1 female vienna white rabbit were dermally exposed to the test substance for 4 hours under semi-occlusive conditions. Symptoms such as erythema (very slight to well-defined; all animals) and edema (very slight; two animals) were observed 4 hours after removal of the test substance. The mean value for erythema and for edema was 0 at the other time points (24, 48, 72 h). Based on the conditions of the performed skin irritation/corrosion test the substance is considered to be not irritating.