Registration Dossier
Registration Dossier
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EC number: 298-078-6 | CAS number: 93777-46-9
Endpoint summary
Administrative data
Description of key information
Skin sensitation (OECD 406): not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for read-across
There are no measured/experimental data on skin sensitisation available for Decyl 2-Ethylhexanoate (CAS 93777-46-9). To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.3, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.
According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.
For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).
As no data are available on sensitisation, read-across to reliable data on the analogue substance Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) was conducted. Additionally, QSAR analysis were performed with the target substance to support the evaluation of the skin sensitizing properties.
CAS 135800-37-2
A Guinea pig maximisation test was performed with Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) according to OECD Guideline 406 (Steiling, 1991). 20 test and 10 control animals (Pirbright white guinea pigs) were induced intradermally with 0.5% test substance diluted in paraffin oil on both sides of the spine with and without Freud's complete adjuvant. 7 days later a 40% test substance dilution was used for the epidermal induction for 48 hours. Another 14 days later the animals were challenged by epidermal induction of the sheared flank skin with test substance diluted to 20% with paraffin oil. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of the test substance. Based on the results of the conducted study, Fatty acids, C8-16, 2-ethylhexyl esters are not considered to exhibit sensitising properties towards the skin.
CAS 93777-46-9
QSAR predictions based on the OECD QSAR Toolbox v3.4 were performed with the target substance (Dr. Knoell Consult, 2017). The predicted skin sensitisation potential based on protein binding potential was modelled in the OECD QSAR Toolbox v3.4. No alerts for protein binding were found according to Protein binding by OASIS v1.4, Protein binding by OECD and Protein binding alerts for skin sensitisation v1.4.
Based on these results, especially considering the results of the skin sensitising relevant profiler, OASIS v1.4 (endpoint specific), Decyl 2-Ethylhexanoate is not expected to exhibit skin sensitising properties.
Conclusion on skin sensitising properties
The available measured data for the read-across analogue substance Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) point to non-sensitising properties. QSAR predictions for Decyl 2-Ethylhexanoate (CAS 93777-46-9) revealed no alerts for protein binding indicative of skin sensitising properties. Thus, Decyl 2-Ethylhexanoate (CAS 93777-46-9) is not considered as skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
Based on the analogue read-across approach and supporting data based on QSAR analysis, 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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