Registration Dossier
Registration Dossier
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EC number: 244-859-1 | CAS number: 22235-81-0
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- EC Number:
- 244-859-1
- EC Name:
- Endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- Cas Number:
- 22235-81-0
- Molecular formula:
- C19H27NO3
- IUPAC Name:
- Endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
3 female New Zealand White Rabbits derived from a controlled full barrier-maintained breeding system (spf).
Source: Harlan Winkelmann GmbGH, D-33178 Borchen
AMINAL HUSBANDRY
Semi-barrier in air-conditioned rooms with the following conditions:
- Temperature: 18 +/- 3 degC
- Relative Humidity: 55 +/- 10%
- Artificial light, lighting regime 12:12hrs, light 6.30-18.30
- Air change: at least 10x / hour
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Housed in ABS-plastic rabbit cages, floor 4200 sq. cm.
Adequate acclimatization period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: cotton seed oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 gram of test item to an area of approximately 6 sq.cm.
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- Preparation of the Animals
- Approximately 24 hrs. before the test, fur was removed from the dorsal area of the trunk by clipping,
Application
- The test item was applied in a single dose to a small area (approx. 6 sq.cm) of skin on one side of the dorsal area with a gauze patch, which was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item SCH 1000 / II-III Tropaester NV showed no irritant/corrosive effects.
In this irritation study the test item SCH 1000 / II-III Tropaester NV was applied to one site of the closely clipped backs of 3 rabbits (strain NZW) at a dose of 0.5 g per application site. The untreated other side served as control.
The application site 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 after removal of the dressing.
The test item SCH 1000/ II-III Tropaester NY showed no irritant effects on the intact skin after a contact time of 4 hours.
No other clinical signs of toxicity were found.
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