Registration Dossier
Registration Dossier
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EC number: 922-676-4 | CAS number: 286426-31-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol
- Cas Number:
- 286426-31-1
- Molecular formula:
- C17 H20 O2
- IUPAC Name:
- 3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: solid
- Analytical purity: 99.7 %
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg or
Harlan Winkelmann GmbH; D-33178 Borchen
- Housing: Individually housed in ABS- plastic rabbit cages, floor 4200 cm²
- Diet : Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free-TPF
- Water : Free access to tap water ( drinking water, municipal residue control, microbiol.controlled periodically
- Acclimation period: Adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12:12 , light 6:30 - 18:30
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 g - Duration of treatment / exposure:
- 4-hour period
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed by using water
- Time after start of exposure: 4 hour
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 284,283,281
- Time point:
- other: 1,24,48,72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 284,283,281
- Time point:
- other: 1,24,48,72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Irritation parameter Basis Time point Score
erythema score animal: 284 1 h 0
erythema score animal: 284 24 h 0
erythema score animal: 284 48 h 0
erythema score animal: 284 72 h 0
erythema score animal: 283 1 h 0
erythema score animal: 283 24 h 0
erythema score animal: 283 48 h 0
erythema score animal: 283 72 h 0
erythema score animal: 281 1 h 0
erythema score animal: 281 24 h 0
erythema score animal: 281 48 h 0
erythema score animal: 281 72 h 0
edema score animal: 284 1 h 0
edema score animal: 284 24 h 0
edema score animal: 284 48 h 0
edema score animal: 284 72 h 0
edema score animal: 283 1 h 0
edema score animal: 283 24 h 0
edema score animal: 283 48 h 0
edema score animal: 283 72 h 0
edema score animal: 281 1 h 0
edema score animal: 281 24 h 0
edema score animal: 281 48 h 0
edema score animal: 281 72 h 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item L-Benzyladrianol Base schowed no irritation/
corrosive effects. - Executive summary:
In this irritation study the test item L-Benzyladrianol Base was applied to one side of the closely clipped backs of 3 rabbites
(strain NZW) at a dose of 0.5 g per application site. The untreated other side served as control.
The application side was covered with a semi-occlusive bandage for a 4 hour-contact time.
Observations were recorded and compared to the control sites,1 h, 24 h, 48 h and 72 hours afetre removal of the dressing.
The test item L-Benzyladrianol Base schowed no irritant effects on the intact skin after a contact time of 4 hours.
No other clinicla sings of toxicity were found.
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