Registration Dossier
Registration Dossier
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EC number: 233-117-2 | CAS number: 10039-33-5
Endpoint summary
Administrative data
Description of key information
skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitisation of the substance was evaluated by considering experimental data on Similar Substance 01. Furthermore, QSAR Toolbox 4.1 evaluations is also taken into account. Justification for Read Across is given in Section 13 of IUCLID.
A GLP study conducted to standardised guidelines OECD 429 and EU Method B.42, using the mouse Local Lymph Node Assay, was used to assess the skin sensitisation of the analogue substance. The test material was applied as a 5 %, 10 % or 25 % w/w preparation in propylene glycol. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study. The isotope concentration induced by the test material was less than three-fold at all test concentrations and therefore the test material is considered to be unlikely to be a skin sensitiser.
Structural alerts identified in the QSAR Toolbox 4.1 are related to the skin sensitisation potential prediction such as: protein binding potency, protein alerts for skin sensitisation and protein binding potency h-CLAT. These alerts are basically identified due to the presence of alpha, beta-carbonyl compounds with polarized double bonds and were not identified for Similar Substance 01. Due to the absence of experimental data on the substance itself and based on the aforementioned evaluation, the substance could be expected to have a sensitisation potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In-vivo LLNA study results and structural alerts identified are considered for the classification of the substance.
The (similar) substance was assessed for its allergic potential in the in-vivo LLNA study. According to CLP Regulation (EC) No. 1272/2008 a substance is classified in sub-category 1 A if the EC3 is≤ 2 % and in sub-category 1B if the EC3 is > 2. In the present study the EC3 value could not be determined as the Stimulation Index (S.I) in all the tested concentrations was below 3. Having a S.I. below 3 means that no significant effect and neither a sensitising potential can be identified.
On the contrary, structural alerts for skin sensitisation were identified for the substance; these alerts were not identified for the similar substance used in the in vivo LLNA study.
Taking in consideration the above and following a precautionary approach, the substance should be classified as a skin sensitiser -Category 1 (H317) according to the CLP Regulation.
No sub-classification can be made between Cat. 1A and 1B, as this is only possible when an in-vivo study for the substance is available.
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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