Registration Dossier

Administrative data

Description of key information

Results are available from two modern, GLP-compliant, guideline studies that have assessed the skin and eye irritation potential of NExBTL renewable diesel in the rabbit. Knowledge of the chemistry of the substance and its low vapour pressure indicates it will not be irritating to the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The skin and eye irritation potential of undiluted NExBTL renewable diesel was determined in two guideline tests conducted using the rabbit (method B4 and method B5 of directive 2004/73/EC, respectively). Both studies were GLP-compliant and the information is reliable and fully adequate for evaluation. The test substance caused mild, fully reversible irritation in both studies, however the magnitude and duration of the responses obtained were insufficient to require classification. Observations made during a guideline acute dermal toxicity study (method B3 of directive 2004/73/EC) suggest that NExBTL renewable diesel may cause solvent-related defatting of the skin.


Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: slightly irritating

Justification for classification or non-classification

No classification required under Directive 67/548/EEC or Regulation EC 1272/2008 for skin or eye irritation (severity and duration scores below threshold for classification). However solvent-related defatting of skin indicates that R66 and the supplemental hazard statement EUH066 (Repeated exposure may cause skin dryness or cracking) should be applied according to Directive 67/548/EEC Regulation EC 1272/2008 or Regulation EC 1272/2008, respectively.

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