Registration Dossier
Registration Dossier
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EC number: 221-070-0 | CAS number: 2997-92-4
Endpoint summary
Administrative data
Description of key information
The substance has skin sensitisation properties as demonstrated in an in vivo test and reported in a case study for production workers.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Although a recent in vivo LLNA study is available indicating no skin sensitation properties, available human data on workers exposed to the substance as well as another in vivo study with guinea pigs indicate skin sensitation properties.
Justification for selection of skin sensitisation endpoint:
Two in vivo studies available. Additionally, one case report on sensitation in humans (production worker) is available.
The study by Thompson is selected due to the acceptable reliablity of the study and the observance of the precautionary principle.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The presented substance has indication for skin sensitisation. The substance is not an Isocyanate and there are no structural alerts as mentioned in the flow chart (REACH technical guidance document IR/CSA: scheme of R.7a, Fig 7.3-2). The available Mouse Local Lymph Node assay indicates no sensitisation potential. Therefore, in a weight of evidence approach, the present data indicate no respiratory potential.
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008 the substance is classified as skin sensitiser category 1. For this classification the substance has to be labelled with the signal word “Caution”.
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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