Registration Dossier
Registration Dossier
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EC number: 614-590-8 | CAS number: 68552-19-2
Endpoint summary
Administrative data
Description of key information
Skin sensitisation (LLNA, GLP): not sensitising (RA CAS 147256-33-5 and CAS 68334-05-4)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Justification for read-across
There are no data on skin sensitisation available for Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2). Thus, read-across from appropriate substances are conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Information will be taken into account from the analogue substances Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) and Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.3.
A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
CAS 147256-33-5
The skin sensitisation potential of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) was determined by a local lymph node assay according to OECD Guideline 429 and in compliance with GLP (Harlan Laboratories, 2012). Groups of five mice were exposed daily, for three consecutive days, to 25, 50 and 100% of the test substance or to the vehicle alone, on the dorsum of both ears. Subsequently, mice were injected intravenously with [3H]-thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes. [3H]-thymidine stimulation indices after exposure to 25, 50, and 1000% with the test substance, were 1.68, 1.54 and 1.82, respectively. Thus, under the conditions of the test, the test substance revealed no skin sensitising properties.
CAS 68334-05-4
The skin sensitisation potential of Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) was determined by a local lymph node assay according to OECD Guideline 429 and in compliance with GLP (Notox B.V., 2010). Groups of five mice were exposed daily, for three consecutive days, to 25, 50 and 100% of the test substance or to the vehicle alone, on the dorsum of both ears. Subsequently, mice were injected intravenously with [3H]-thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes. [3H]-thymidine stimulation indices after exposure to 25, 50, and 100% with the test substance, were 1.6, 1.6 and 2.5, respectively. Thus, under the conditions of the test, the test substance revealed no skin sensitising properties.
In conclusion, based on the analogue approach, Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) is not considered to exhibit skin sensitising properties.
Justification for classification or non-classification
Based on the analogue approach, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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