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:

The skin sensitization potential of of a structurally similar sbustance, dibasic esters, was assessed in two in vivo assays. A mouse Local Lymph Node Assay (LLNA), of reliability 1 according to Klimisch cotation criteria, was selected as a key study based on its high reliability and as it is the reference method endorsed by REACH. Several concentration of dibasic esters blend were tested up to 100%, and no increase in the stimulation indices occurred, illustrating the absence of skin sensitization. This is confirmed by a Guinea-Pig Maximisation Test (GPMT), of reliability 2 according to Klimisch cotation criteria and therefore selected as a supporting study, where the concentrations of 10% and 100% were tested. No cutaneous reactions were observed following challenge, corroborating the absence of skin sensitization potential.


Migrated from Short description of key information:
No indication of skin sensitization potential in a Local Lymph Node Assay and a Guinea Pig Maximisation Test.

Respiratory sensitisation

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

The respiratory sensitization potential of dibasic esters was not formally assessed in a dedicated study, but there was no indication of specific immunotoxicity in rats exposed by inhalation for up to 90 days (see "7.5. Repeated dose toxicity" section for details).

 

Therefore dibasic ester blend is not considered to be a respiratory sensitizer.


Migrated from Short description of key information:
Not formally assessed but no indication of specific immunotoxicity in 90-day inhalation toxicity studies in rats.

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP), and given the absence of positive reactions in a LLNA and a GPMT, or signs of specific immunotoxicity in a rat 90 -day toxicity study by inhalation, dibasic ester blend is not classified as a skin or respiratory sensitizer.