Registration Dossier
Registration Dossier
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EC number: 205-154-4 | CAS number: 134-72-5
Skin irritation / corrosion
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- other: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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:
- 1 986
- 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
- Reference substance name:
- Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate
- EC Number:
- 205-154-4
- EC Name:
- Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate
- Cas Number:
- 134-72-5
- Molecular formula:
- C10H15NO.1/2H2O4S
- IUPAC Name:
- bis([(1R,2S)-1-hydroxy-1-phenylpropan-2-yl](methyl)azanium) sulfate
- Details on test material:
- Name of the test substance used in the study report: (-)-Ephedrin-Sulfat
Constituent 1
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, FRG
- Weight at study initiation: mean 3.21 kg
- Housing: 1 animal per cage, stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm; no bedding in cages, saw-dust in waste trays
- Diet: Kliba 341, 4 MM, Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g 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
- 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:
- VEHICLE
- Vehicle: 80% aqueous formulation (w/w).
- Justification choice of vehicle: Because of the natural moisture of the skin, distilled water is used to prepare the suspensions so that the test can be carried out under as physiological conditions as possible.
TEST MATERIAL
- The test patches (2.5 x 2.5 cm) were covered with an about 0.5 mm layer of the suspension (thus, about 0.5 g of thes uspension is applied). - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- - Clipping of the fur: at least 15 hours before application
- Application site: upper third of the back or flanks
- Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Readings: 30 - 60 minutes after removal of the test patches and 24, 48 and 72 h after beginning of application.
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. The intact skin of three Vienna White rabbits was exposed by a single topical application of an amount of 0.5 g of the test substance for 4 hours 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.
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