Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Remarks:
other: Based on category approach.
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

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
Remarks:
Not relevant for category approach.
Type of study:
other: LLNA and other data were used in the category approach.

Test material

Constituent 1
Reference substance name:
D-pentose, oligomeric, C14 and C18 alkyl glycosides
EC Number:
940-643-2
IUPAC Name:
D-pentose, oligomeric, C14 and C18 alkyl glycosides

Results and discussion

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:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
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-6781 is not a skin sensitiser (see category approach report).