Registration Dossier
Registration Dossier
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EC number: 267-015-4 | CAS number: 67762-38-3 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid methyl ester and SDA Reporting Number: 11-010-00.
Endpoint summary
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)
Additional information
Both studies for each end points on the substance and on the analogous substance fatty acid rape oil methyl esters showed a slight irritation after one hours completely reversible in a few hours. The substance is then considered not irritant.
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
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.
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