Registration Dossier
Registration Dossier
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EC number: 202-255-5 | CAS number: 93-53-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from study report
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of the DPRA with a Three-Test Battery for In Vitro Evaluation of Skin Sensitization
- Author:
- W Stokes, T Burns, J Strickland, L Rinckel, D Allen NICEATM/NTP/HHS, RTP, NC, USA; ILS, Inc., RTP, NC, USA
- Year:
- 2 012
- Bibliographic source:
- NICEATM–ICCVAM SOT 2012 Poster
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
- GLP compliance:
- no
- Type of study:
- other: Direct protein reactivity assay (DPRA); Human cell line activation test (h-CLAT); KeratinoSens; Local lymph node assay
Test material
- Reference substance name:
- Hydratropaldehyde
- EC Number:
- 202-255-5
- EC Name:
- Hydratropaldehyde
- Cas Number:
- 93-53-8
- Molecular formula:
- C9H10O
- IUPAC Name:
- hydratropaldehyde
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material: Hydratropaldehyde
- Molecular formula: C9H10O
- Molecular weight: 134.17 g/mol
- Smiles notation: CC(C=O)C1=CC=CC=C1
- Substance type: Liquid
- Physical state: Organic
- Impurities (identity and concentrations): No data
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: No data available
- Vehicle:
- other: AOO = Acetone: olive oil (4:1 by volume)
- Concentration / amount:
- No data available
Challengeopen allclose all
- Route:
- other: No data available
- Vehicle:
- other: AOO = Acetone: olive oil (4:1 by volume)
- Concentration / amount:
- No data available
- No. of animals per dose:
- No data available
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vitro / in chemico
Results
- Parameter:
- other: Migrated information from in vitro study
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Clinical observations: sensitizing.
Any other information on results incl. tables
Not specified
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
- Executive summary:
- By using different
in vitro assays: DPRA, the human cell line activation test (h-CLAT), and
KeratinoSens use for skin sensitization testing. The murine local lymph
node assay was used as the reference test.
From the above table it was found that theHydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
According to the CLP regulations the chemical was classified in category skin sensitization 1.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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