Registration Dossier
Registration Dossier
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EC number: 204-288-0 | CAS number: 118-93-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-07-15 to 1997-07-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2'-hydroxyacetophenone
- EC Number:
- 204-288-0
- EC Name:
- 2'-hydroxyacetophenone
- Cas Number:
- 118-93-4
- Molecular formula:
- C8H8O2
- IUPAC Name:
- 1-(2-hydroxyphenyl)ethan-1-one
- Details on test material:
- Name of the test substance used in the study report: o-Hydroxyacetophenon
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna Ltd., Huntingdon, Cambridgeshire. England, UK
- Age at study initiation: 10 - 12 wks
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: individually in metal cages
- Diet: ad libitum, standard diet (SDS Stanrab /P) SQC Rabbit Diet)
- Water: ad libitum, tap water
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.5 - 21.5
- Humidity (%): 60 - 74
- Air changes (per hr): 19
- 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 served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorso lumbar region (6.25 mm²)
- Type of wrap if used: elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize et al. (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No dermal reaction to treatment was observed in any animal throughout the study period.
- Other effects:
- There were no signs of toxicity observed in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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