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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

Referenceopen allclose all

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.

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)