Registration Dossier
Registration Dossier
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EC number: 605-546-9 | CAS number: 169280-10-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 30 to september 25 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to international guidelines.
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 605-546-9
- Cas Number:
- 169280-10-8
- Molecular formula:
- C16 H20 O3
- IUPAC Name:
- 4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch: W0147
Sample: 181669 1 001
Date of arrival: August 23, 2001
Physical state: powder
Storage conditions: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino (strain not defined)
- Details on test animals or test system and environmental conditions:
- Breeding: Dr.Zimmermann Schweizer Hof, D-73453 Untergröningen/Aalen, Germany
Diet: Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffesen Kraftfutterwerk Kehl, ad libitum
Water: Community tap water from Karlsruhe: free access for the animals by daily changing of the watering-bottles.
Husbandry: Rabbits housed individually in wire grating cages (2450 cm², height 42 cm) without bedding.
Temperature: 20-23 °C
Relative humidity: 30-70%
Light-dark rythm: 12 : 12
Animals were acclimated to the test conditions for 5 days prior to the administration.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg per animal
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 6 d
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 6 days following exposure
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score was 0 throughout the 6-day observation period.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 6 days following exposure
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score was 0 throughout the 6-day observation period.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 6 days following exposure
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score was 0 throughout the 6-day observation period.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 6 days following exposure
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score was 0 throughout the 6-day observation period.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 6 days following exposure
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score was 0 throughout the 6-day observation period.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 6 days following exposure
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score was 0 throughout the 6-day observation period.
- Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test experimental conditions, the substance is considered to be not irritant for the skin in rabbits.
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