Registration Dossier
Registration Dossier
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EC number: 402-670-3 | CAS number: 106797-53-9 DAROCUR (R) 2959; DAROCUR 2959
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD 405, Directive 84/449/EEC, B.5 and compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-hydroxy-4'-hydroxyethoxy-2-methylpropiophenone
- EC Number:
- 402-670-3
- EC Name:
- 2-hydroxy-4'-hydroxyethoxy-2-methylpropiophenone
- Cas Number:
- 106797-53-9
- Molecular formula:
- C12H16O4
- IUPAC Name:
- 2-hydroxy-4'-hydroxyethoxy-2-methylpropiophenone
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 100 MG
- Duration of treatment / exposure:
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48, 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- not specified
Any other information on results incl. tables
conjunctivae score (redness): Max. duration: h; Max. value at end of observation period: 0 (related to all animals);
chemosis score: Max duration: h; Max.value at end of observation period: 0 (related to all animals);
cornea score: Max.duration: h; Max.value at end of observation period: 0 (related to all animals);
iris score: Max. duration: h; Max. value at end of observation period: 0 (related to all animals).
All Draize scores were zero. No signs of systemic toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not classified as irritating to the eye.
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