Phenylephrine hydrochloride

Eye irritation

Administrative data

Endpoint:

eye 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other: Non-GLP, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues 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: 3.43 kg, Females: 3.49 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

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye

Amount / concentration applied:

0.1 mL (about 37 mg of the comminuted test substance )

Duration of treatment / exposure:

once

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

2 males, 1 female

Details on study design:

The test substance was applied to the conjuctival sac of the right eyelid. The substance was not washed out. Readings were performed 1, 24, 48, and 72 hours after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 + 48 + 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 + 48 + 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 + 48 + 72 hours

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 + 48 + 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

One hour after exposure well-defined conjunctival redness was observed in all test animals. In addition, in all treated animals slight chemosis was observed. Twenty-four hours after application of the test substance, in one male rabbit well-defined conjunctival redness and slight chemosis was observed and in the other male rabbit, slight conjunctival redness was observed. Also pupil contraction was observed in these two animals. No effects were observed at later time points and in the female rabbit at the 24 hours time-point after application of the test substance.