Registration Dossier

Diss Factsheets

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: Guideline study (no GLP). Test substance concentration 80%.

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)
Deviations:
no
GLP compliance:
no

Test material

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

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 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

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the fur
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: very slight to well-defined erythema after 4 h in all animals, but reversible within 24 h.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: very slight edema in 2/3 animals after 4 h, but reversible within 24 h.
Irritant / corrosive response data:
Symptomes such as erythema (very slight to well-defined; all animals) and edema (very slight; two animals) only occurred after 4 h. Mean value for erythema and for edema was 0.0 (24, 48, 72 h).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information