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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:


Sensitising properties ofFatty acids, C16-18 (even numbered), aluminum saltswere assessed in a GLP-conducted local lymph node assay according to OECD 429 in female CBA/CaOlaHsD mice (5 animals/group) (Lütkenhaus, 2013c). Based on the results of a pre-screen test, animals were exposed to the test substance in concentrations of 6.25, 12.5 and 25% (w/v) in AOO. Neither mortality, clinical signs of toxicity, alterations in body weight or local effects at the application site were observed until the end of the study. Slight increases in lymph node weights lay within the standard deviation of control animals and are therefore not considered as indicative for a sensitization reaction. Further, no lymphoproliferative response was noted for the test substance: the observed stimulation index values were 1.2, 1.1 and 0.9 after topical application of 6.25, 12.5 and 25%, respectively. Topical application of the positive control substance phenylendiamine (1%) induced a significant lymphoproliferative response as shown by a stimulation index value of 7.3 thereby validating the study. Thus, Fatty acids, C16-18 (even numbered), aluminum salts are not considered as sensitising.

Migrated from Short description of key information:
Skin sensitisation (OECD 429): not sensitising

Justification for selection of skin sensitisation endpoint:
There is only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.