Registration Dossier
Registration Dossier
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EC number: 267-184-4 | CAS number: 67801-64-3
Endpoint summary
Administrative data
Description of key information
General Weight of Evidence based on:
- Modified version of the Magnusson and Kligman methodology (Potokar, 1977, Rel.3) : no signs of skin sensitisation
- A human maximization test performed on volonteers (see section 7.10.4) was used as supporting study to strengthen the absence of skin sensitisation from 2-tert-butylcyclohexyl ethyl carbonate in mammalian.
- a weight of evidence approach for the predictions using the read-across analysis from OECD QSAR Toolbox v4.0, QSAR analyses from Danish QSAR Database and the structural alerts from Toxtree v2.6.13 and OECD QSAR Toolbox profilers.
It can be concluded that the registered substance and its predicted metabolites are non-sensitisers to the skin.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No key study was selected since a weight of evidence approach was followed for this endpoint.
In dermal sensitisation study (Potokar, 1977), the test compound was tested in 20 female guinea-pigs using a modified version of the Magnusson and Kligman method (20 treated animals + 10 controls) with deviations. Animals were challenged with 2 pairs of intradermal injections (0.1 mL) per animal 10 times with 2 -3 days intervals of test substance 10 % in olive oil and 2/ test substance 5 % mixed with FCA (1:1). For the challenge, the test compound was tested at 5 % in olive oil 14 days after induction.
Mild to severe redness and necrotic changes at the injection sites could be observed after induction.
4 out of 20 test animals showed a weak non persistent redness of the skin 48 h after challenge.
Under the test conditions, Ethyl-2-tert.-butylcyclohexyl-carbonate did not show any skin sensitising potential in guinea pigs. However, this non-GLP study was performed with deviations from Magnusson and Kligman methodology: no rationale for dose selection for induction, FCA was not mixed with water of physiological saline, no epicutaneous induction was performed, conditions of challenge are not detailed, higher non irritating dose may have been tested for challenge (as test substance was found non irritating at 5 %), historical or concurrent positive control data and certificate of analysis are not included.
A human maximization test performed on volonteers (see section 7.10.4) was used as supporting study to strengthen the absence of skin sensitisation from 2-tert-butylcyclohexyl ethyl carbonate in mammalian.
Finally, to complete the weight of evidence approach, relevant predictions such as those for the protein binding key event of the adverse output pathway (AOP) for skin sensitisation were considered. Among these predictions, the one from VEGA v1.1.4 was not reliable and therefore was not considered for the final conclusion. Based on a weight of evidence approach using the read-across analysis from OECD QSAR Toolbox v4.0, QSAR analyses from Danish QSAR Database and the structural alerts from Toxtree v2.6.13 and OECD QSAR Toolbox profilers, it can be concluded that Ethyl-2-tert.-butylcyclohexyl-carbonate and its predicted metabolites are non-sensitisers to the skin.
Based on a general weight-of-evidence approach taking into account the in vivo study, the human maximisation test and the relevant predictions from in silico methods for both the test substance and its metabolites, Ethyl-2-tert.-butylcyclohexyl-carbonate
is not considered to be a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No study is available. However based on the skin sentisation results, no respiratory sensitisation is expected.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Based on the available data no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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