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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other: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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:
(R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride
EC Number:
205-153-9
EC Name:
(R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride
Cas Number:
134-71-4
Molecular formula:
C10 H15 N O .Cl H
IUPAC Name:
(1-hydroxy-1-phenylpropan-2-yl)(methyl)azanium chloride
Details on test material:
- Name of the test substance used in the study report: DL-Ephedrin-HCl

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D6050 Offenbach/Main, FRG
- Weight at study initiation: mean 3.21 kg
- Housing: 1 animal per cage, stainless steel cage with wire mesh walk floors, floor area: 40 cm x 51 cm, no bedding in cages, sawdust in the waste trays.
- Diet: 130 g per animal per day, Kliba 341, 4 MM, Firma Klingentalmuehle AG, CCH-4303 Kaiseraugst, Switzerland
- Water: 250 mL per day, tap water
- Acclimation period: at least 8 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: the test patch is covered with an about 0.5 mm layer of the suspension (thus about 0.5 g)
- Concentration: 80 % aqueous formulation (w/w)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm fo upper third of the back or flanks
- 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: lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the substance is considered to be not irritating or corrosive to the skin.
Executive summary:

The potential to cause acute dermal irritation or corrosion was assessed, in a OECD 404 guideline study, by a single topical application of an amount of 0.5 mL of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with a semiocclusive dressing. After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours after removal. No effects were observed. It was concluded that the test substance was not irritating to the skin.