Pseudoephedrine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study (no GLP).

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)

Deviations:

no

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

IUPAC Name:

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

Details on test material:

Name: (+)-Pseudoephedrine hydrochloride
Purity: 99-100.5%
Appearance: white chrystals

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, Germany
- Weight at study initiation (mean): 3.43 kg (Males), 3.49 kg (female)
- Housing: single housing in stainless steel wire mesh cages
- Diet: Kliba-Labordiaet 341, 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

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye

Amount / concentration applied:

Concentration: 37 mg
Amount applied (Bulk volume): 0.1 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

2 males, 1 female

Details on study design:

Readings: 1h, 24 h, 48 h, 72 h
Comment: not rinsed
Scoring system: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Conjunctivae redness (well-defined) and chemosis (slight) observed in all 3 animals after 1h. After 24 h: 2 cases of conjunctivae redness (slight and well-defined) and of contracted pupil, one case of chemosis (slight) and one case of opacity-degree of density of the cornea (slight). After 48h: no more symptomes. Means for corneal opacity: 0.1, means for conjunctivae redness: 0.3, means for chemosis: 0.1. (details see "Any other information")

Any other information on results incl. tables

Table 1: Eye irritation scores of treated animals without rinsing at 24 h, 48 h, and 72 h.

		24 h			48 h			72 h
	Rabbit No.	0751	0850	0780	0751	0850	0780	0751	0850	0780
Cornea	Opacity	1	0	0	0	0	0	0	0	0
	Area	1	0	0	0	0	0	0	0	0
Iris	Iris	0	0	0	0	0	0	0	0	0
Conjunctivae	Redness	2	1	0	0	0	0	0	0	0
	Chemosis	1	0	0	0	0	0	0	0	0
	Discharge	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information