Registration Dossier
Registration Dossier
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EC number: 224-116-8 | CAS number: 4203-89-8
Endpoint summary
Administrative data
Description of key information
The endpoint is waived as the substance is corrosive to skin. Based on QSAR, the substance is self-classified as a Cat 1 sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
- Endpoint:
- skin sensitisation, other
- Remarks:
- QSAR
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- QSAR predictions were used for skin sensitization. The criteria listed in Annex XI of Regulation No. 1907/2006 are considered to be adequately fulfilled and therefore, the endpoint sufficiently covered and suitable for risk assessment.
- Principles of method if other than guideline:
- QSAR
- Justification for non-LLNA method:
- QSAR
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on QSAR predictive analysis, the substance is considered to be a skin sensitizer, Cat 1
- Executive summary:
Based on QSAR predictive analysis using four well known models (DEREK Nexus v.6.0.1; Biovia Discovery Studio 2018 (TOPKAT); VEGA-QSAR v.1.1.4; and OECD QSAR Toolbox, v. 4.2) the substance is considered to be a skin sensitizer, Cat 1.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Based on QSAR analysis of four well known models (DEREK Nexus v.6.0.1;Biovia Discovery Studio 2018 (TOPKAT);VEGA-QSAR v.1.1.4; andOECD QSAR Toolbox, v. 4.2), the substance is considered to be a skin sensitizer, Cat 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is self-classified as a skin sensitizer (Cat 1) based on the methacrylate functional group (QSAR)
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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