Registration Dossier
Registration Dossier
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EC number: 204-288-0 | CAS number: 118-93-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-07-21 to 1997-07-26
- 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 81-4 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna Ltd., Huntingdon, Cambridgeshire. England, UK
- Age at study initiation: 11 - 13 wks
- Weight at study initiation: 2.5 - 3.0 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): 15.5 - 21.5
- Humidity (%): 50 - 74
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- Single exposure. Eyes of the animals were not washed.
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: according to Draize et al (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed. A diffuse, crimson colouration of die conjunctivae with slight swelling and above normal discharge to discharge with moistening of the lids and hairs just adjacent to the lids was observed in all animals. These reactions had resolved in all instances by one or two days after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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