Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
(Q)SAR
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
This endpoint study record is a QSAR prediction. The prediction of the skin sensitisation potential of m-toluic acid is sufficient to fulfil the information requirements as further explained in the provided endpoint summary. The reliable documentation of the applied method (QMRF) and the prediction (QPRF) is attached under “Attached justification” in this endpoint summary.

Data source

Reference
Title:
Skin Sensitization model (CAESAR) - v. 2.1.6
Year:
2017
Bibliographic source:
VEGA in silico platform - version 1.1.4, www.vega-qsar.eu

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: REACH guidance on QSARs R.6, May 2008
Principles of method if other than guideline:
VEGA for estimating the skin sensitisation on mouse (local lymph node assay model). The model extends the original CAESAR model.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Cc1cccc(c1)C(=O)O

Results and discussion

In vivo (LLNA)

Results
Key result
Remarks on result:
no indication of skin sensitisation based on QSAR/QSPR prediction

Any other information on results incl. tables

Skin Sensitization model (CAESAR) - v. 2.1.6 predicted that m-toluic acid may not have skin sensitisation potential

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the model outcome “m-toluic acid” is considered as a non-sensitising substance in the sense of Regulation (EC) No 1907/2006. The substance under concern is within the applicability domain of the “VEGA - Skin Sensitisation model (CAESAR) – v.2.1.6”. Hence, the prediction is fully reliable to replace an in vivo skin sensitisation test to fulfill requirements for Regulation (EC) No 1907/2006 (REACH) Annex VII section 8.3.