Registration Dossier
Registration Dossier
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EC number: 309-849-4 | CAS number: 101316-44-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with sufficient documentation; acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no scoring at 1 hr after instillation of test substance)
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the USA, Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Acetophenone
- EC Number:
- 202-708-7
- EC Name:
- Acetophenone
- Cas Number:
- 98-86-2
- Molecular formula:
- C8H8O
- IUPAC Name:
- 1-phenylethanone
- Details on test material:
- - Physical state: colourless liquid
- Storage condition of test material: at 20 °C and day light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: J. Scheele, Büderich/Westfalen, 4760 Werl, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1 °C
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- no washout of test substance
- Observation period (in vivo):
- 24, 48, 72 hrs, 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize (see Table 1)
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no effects at any time point
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acetophenone had no irrtitating effect on rabbit eyes.
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