Registration Dossier
Registration Dossier
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EC number: 483-990-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Remarks:
- APP category
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Category is coherent for more than 10 endpoints. Skin sensitiser category approach is notbly based on a clearly negative LLNA study on APP-6505
- Justification for type of information:
- Discussed in the document attached
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Version / remarks:
- Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and
grouping of chemicals - ECHA, May 2008.
- Principles of method if other than guideline:
- Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and
grouping of chemicals - ECHA, May 2008. - GLP compliance:
- no
- Type of study:
- other: LLNA and other data were used in the category approach
Test material
- Reference substance name:
- D-xylofuranose oligomeric dodecyl glycosides (degree of polymerisation = 1)
- Molecular formula:
- C15H30O5
- IUPAC Name:
- D-xylofuranose oligomeric dodecyl glycosides (degree of polymerisation = 1)
- Reference substance name:
- D-xylofuranose oligomeric dodecyl glycosides, degree of polymerisation 2
- Molecular formula:
- C20H38O9
- IUPAC Name:
- D-xylofuranose oligomeric dodecyl glycosides, degree of polymerisation 2
- Reference substance name:
- D-xylofuranose oligomeric tetradecyl glycosides (degree of polymerisation = 1)
- Molecular formula:
- C17H34O5
- IUPAC Name:
- D-xylofuranose oligomeric tetradecyl glycosides (degree of polymerisation = 1)
- Reference substance name:
- D-xylofuranose oligomeric tetradecyl glycosides, degree of polymerisation 2
- Molecular formula:
- C20H38O9
- IUPAC Name:
- D-xylofuranose oligomeric tetradecyl glycosides, degree of polymerisation 2
- Reference substance name:
- D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 1
- Molecular formula:
- C15H30O5
- IUPAC Name:
- D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 1
- Reference substance name:
- D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 2
- Molecular formula:
- C20H39O9
- IUPAC Name:
- D-glucopyranose oligomeric dodecyl glycosides, degree of polymerisation 2
- Reference substance name:
- D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 1
- Molecular formula:
- C15H30O5
- IUPAC Name:
- D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 1
- Reference substance name:
- D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 2
- Molecular formula:
- C20H38O9
- IUPAC Name:
- D-glucopyranose oligomeric tetradecyl glycosides, degree of polymerisation 2
- Reference substance name:
- Glucose
- EC Number:
- 200-075-1
- EC Name:
- Glucose
- Cas Number:
- 50-99-7
- Molecular formula:
- C6H12O6
- IUPAC Name:
- D-glucose
- Reference substance name:
- Xylose
- EC Number:
- 200-400-7
- EC Name:
- Xylose
- Cas Number:
- 58-86-6
- Molecular formula:
- C5H10O5
- IUPAC Name:
- Oxane-2,3,4,5-tetrol (D)
- Reference substance name:
- Tetradecanol
- EC Number:
- 204-000-3
- EC Name:
- Tetradecanol
- Cas Number:
- 112-72-1
- Molecular formula:
- C14H30O
- IUPAC Name:
- Tetradecan-1-ol
- Reference substance name:
- Dodecan-1-ol
- EC Number:
- 203-982-0
- EC Name:
- Dodecan-1-ol
- Cas Number:
- 112-53-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- Dodecan-1-ol
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.68
- Test group / Remarks:
- concentration 5%
- Key result
- Parameter:
- SI
- Value:
- 1.24
- Test group / Remarks:
- Concentration 10%
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Concentration 25%
Any other information on results incl. tables
The category approach is notably based on the substance that may potentially exhibit higher sensitisation
and that showed stimulation indices only around 1.0 in a LLNA test (reliabiity 1, GLP). The APP category
is clearly not skin sensitiser
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not sensitising
- Conclusions:
- Based on read-across within the APP category and other arguments (comparison with other alkyl polyglycosides, absence of reactivity with amino-acids and proteins), it can be concluded with confidence that APP-6726 is not a skin sensitiser (see category approach report).
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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