Registration Dossier

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:

A Local Lymph Node Assay was performed on the substance according to the OECD test guideline No. 429 and in compliance with GLP. A significant lymphoproliferation was noted in the positive control group, therefore the study was considered valid. The test material (1%-40%) did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay. None of the mice assigned to this study experienced visible irritation or other adverse toxic effects.

However, this study cannot be regarded as the key study for hazard assessment purpose since there was neither a screening study nor an adequate justification for the selection of the highest concentration tested. Indeed, the highest concentration tested should normally maximise exposure while avoiding systemic toxicity and/or excessive local skin irritation which was not achieved for this study.

Therefore a weight-of evidence approach using the LLNA result, the HRIPT result and two QSARs was considered more robust to conclude on the skin sensitisation potential of the substance.

In the HRIPT study, there was no evidence of skin sensitisation to the substance at 5% in diethyl phtalate/ethanol (75%/25%).

Both the OECD QSAR Toolbox and Toxtree did not show any alert for skin sensitisation with the substance.

Based on the whole data, it can be concluded that the substance is not a skin sensitiser.


Migrated from Short description of key information:
Skin sensitisation: Not sensitising, WoE (LLNA, HRIPT, QSARs)

Justification for selection of skin sensitisation endpoint:
No key study was selected since all studies were used within a weight-of-evidence approach.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No 1272/2008 including ATP3.

Self-classification:

Based on the available information, no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

No information is available regarding respiratory sensitisation.