Registration Dossier
Registration Dossier
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EC number: 402-670-3 | CAS number: 106797-53-9 DAROCUR (R) 2959; DAROCUR 2959
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404, Directive 84/449/EEC, B4 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Moistened with aqua pro injectione
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible within 3 days.
Any other information on results incl. tables
erythema score: Max. duration: 3 d; Max. value at end of observation period: 0 (related to all animals);
edema score: Max. duration: 0 d; Max.value at end of observation period: 0 (realted to all animals).
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 skin.
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