Registration Dossier
Registration Dossier
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EC number: 242-978-3 | CAS number: 19344-29-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[(2-hydroxyethyl)amino]propanol
- EC Number:
- 242-978-3
- EC Name:
- 3-[(2-hydroxyethyl)amino]propanol
- Cas Number:
- 19344-29-7
- Molecular formula:
- C5H13NO2
- IUPAC Name:
- 3-[(2-hydroxyethyl)amino]propan-1-ol
- Details on test material:
- - Name of the test substance used in the study report: 3-(2-Hydroxyethylamino)-1-propanol
- Physical state: liquid, viscous, achromatic
- Storage condition of test material: Room temperature
- Analytical purity: 99.3 g/100 g
- Lot/batch No.: Abl. Nr. 61-1853
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: mean body weight males 2.87 kg, body weight female 3.06 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2. No bedding in the cages, sawdust in the waste tray.
- Diet: Kliba-laboratory diet, 341 Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Drinking water (about 250 mL tap water/animal/day)
- Acclimation period: At least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes: fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: The test substance was applied in a single dose to the intact untreated skin. The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 mL of the unchanged liquid test substance. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm, upper third of the back or flancks.
- Type of wrap if used: The test patches were secured in position with a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
SCORING SYSTEM:
According to OECD GUIDELINE 404 and EEC L 383A, B.4.
Readings: 1 h , 24 h, 48 h and 72 h after removal of the test patches
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No edema formation was observed in the 72 hour observation period. In all animals well defined erythema was observed 1 hour after the removal of the test substance. This was fully reversible within 72 hours in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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