Registration Dossier
Registration Dossier
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EC number: 252-354-2 | CAS number: 35086-59-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.02. - 12.02.1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and is well documented, but did not stricly follow OECD 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,5-Diacetoxyacetophenon
- IUPAC Name:
- 3,5-Diacetoxyacetophenon
- Details on test material:
- 3,5-Diacetoxyacetophenon
Charge: 96
Analysenattest vom 10.01.1984
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach
- Age at study initiation: 22 - 28 Wochen
- Weight at study initiation: 2,0 - 2,4 kg
- Housing: Einzelhaltung in Drahtkäfigen
- Diet (e.g. ad libitum): Kaninchenzuchtfutter
- Water (e.g. ad libitum):ad libitu
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24° C + 2
- Humidity (%): 55% (50- 65 %),
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- other: okklusiv und semiokklusiv
- Preparation of test site:
- shaved
- Vehicle:
- other: 0,5 ml physiologische Kochsalzlösung
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 g Prüfsubstanz mit 0,5 ml physiologischer Kochsalzlösung - Duration of treatment / exposure:
- 4 Stunden
- Observation period:
- 1 Woche
- Number of animals:
- 3 males, 3 females
- Details on study design:
- Die Prüfsubstanz oder Kochsalzlösung wurde
mit quadratischen (3 x 3 cm) Mullstücken
appliziert und abgedeckt. Rechts wurden die
Mullstücke okklusiv (luftdicht) bzw. links
semiokklusiv (mit Pflaster) verschlossen
und mit einem Schutzverband abgedeckt. Nach
4 Stunden wurden die Mullstücke abgenommen
und die behandelten Hautstellen mit Wasser
abgewaschen und abgetrocknet.
Ablesungszeitpunkte: 1 Stunde, 24 Stunden, 72 Stunden und 1 Woche nach Abnahme der Mullstücke.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Die okklusive bzw. semiokklusive epikutane Applikation von
3,5-Diacetoxyacetophenon während einer Dauer von 4 Stunden
auf gesunder Kaninchenhaut rief bei den 6 untersuchten Tieren
keine Zeichen von primärer Hautreizung (Erythem oder Odem)
während einer Beobachtungsperiode von 1 Stunde bis 7 Tage
nach Applikationsende hervor .
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