Registration Dossier
Registration Dossier
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EC number: 204-814-9 | CAS number: 126-96-5
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: A guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Sodium diacetate
- Lot/batch No.:1000022891
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (after patch removal)
- Number of animals:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: Only slight erythrema was observed in one animal
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sodium diacetate is not irritating for skin.
- Executive summary:
In the study of skinn irritation (according to OECD 404 guideline) was demonstrated that Sodium diacetate is not irritating for skin.
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