Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 404 (1981); EEC Directive 84/449 (1984) Annex V-Method B4, EPA No.798 4470 (1990), MAFF No.4200 (1985)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 413-110-2
- EC Name:
- -
- Cas Number:
- 135861-56-2
- Molecular formula:
- C24H30O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: Sterile codex liquid paraffin
- Amount / concentration applied:
46 mg- Duration of treatment / exposure:
- 4h
- Observation period:
- Presumed to be 72 hrs
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- within 3 days
- Remarks on result:
- other: Maximum duration 48h; Maximum value at end of observation period 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- within 3 days
- Remarks on result:
- other: Maximum duration 0 days; Maximum value at end of observation period 0.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is slightly irritating to the skin and is not classified according to EU CLP criteria.
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