Registration Dossier

Administrative data

Description of key information

The substance is not skin and eye irritating

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

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

Additional information

Both studies for each endpoints on the substance and on the analogous substance fatty acid rape oil methyl esters showed a slight irritation after one hour completely reversible in a few hours; the substance is then considerred not irritant.

Justification for classification or non-classification

In general, esters of long-chain fatty acids are always negative with relation to irritation (from C18 onward), while esters of short-chain fatty acids are always (slightly) positive(up to C10). There are 2 relevant tests, for C16-C18and C18unsaturated me esters and fatty acids, rape oil, me esters , showing no irritation that support this conclusion. Eye irritation tests are negative too and it is unlikely that a substance would be less irritating to eyes than the skin.

However, as it is clear from literature that shorter chain fatty acid me esters can cause skin irritation, therefore this will need to be taken into account in the analysis. Directive 67/548/EEC (DSD) states for substances containing individual components then their classification should be taken into account when determining the classification of a substance. This does not mean automatically using the concentration limits set out in the DSD (for irritation it is 20%) but that would be a useful starting point. If any of the Biodiesel substances contained individual components causing irritation at a concentration>20% then this would be the starting point for any further analysis on irritation.

CONCLUSION

No classification for skin irritation is warranted under 67/548/EEC or Regulation 1272/2008.

No classification for eye irritation is warranted under 67/548/EEC or Regulation 1272/2008.