Registration Dossier
Registration Dossier
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EC number: 700-676-3 | CAS number: 135452-42-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to EU Method B.46 resp. OECD 439 Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): CAS No. 135452-43-6
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
- IUPAC Name:
- 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
- Reference substance name:
- 135452-43-6
- Cas Number:
- 135452-43-6
- IUPAC Name:
- 135452-43-6
- Reference substance name:
- 1-Propanone, 1-[2,3-dihydro-1-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1,3,3-trimethyl-1H-inden-5-yl]-2-hydroxy-2-methyl-
- IUPAC Name:
- 1-Propanone, 1-[2,3-dihydro-1-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1,3,3-trimethyl-1H-inden-5-yl]-2-hydroxy-2-methyl-
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Constituent 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: relative absorbance value
- Value:
- 0.999
- Remarks on result:
- other:
- Remarks:
- Basis: other: % Formazan production (Tissue 1). Time point: 60 minutes. Remarks: relative absorbance value: 99.9%. . (migrated information)
- Irritation / corrosion parameter:
- other: other: relative absorbance value
- Value:
- 0.987
- Remarks on result:
- other:
- Remarks:
- Basis: other: % Formazan production (Tissue 2). Time point: 60 minutes. Remarks: relative absorbance value: 98.7%. . (migrated information)
- Irritation / corrosion parameter:
- other: other: relative absorbance value
- Value:
- 0.97
- Remarks on result:
- other:
- Remarks:
- Basis: other: % FOrmazan production (Tissue 2). Time point: 60 minutes. Remarks: relative absorbance value: 97.0%.. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative absorbance value
- Value:
- 0.985
- Remarks on result:
- other:
- Remarks:
- Basis: other: % Formazan production Mean. Time point: 60 Minutes. Remarks: relative absorbance value: 98.5%. . (migrated information)
Any other information on results incl. tables
After the treatment with the test item, the relative absorbance values were reduced to 98.5%. This value is well above the threshold for irritation potential (50%).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered as not irritant in the Human Skin Model Test.
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