Registration Dossier
Registration Dossier
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EC number: 202-018-6 | CAS number: 90-82-4
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: Guideline study (no GLP). Test substance concentration 80%.
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)
- Deviations:
- no
- GLP compliance:
- no
Test material
- 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
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, 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
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