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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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other: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
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.