Registration Dossier

Administrative data

Description of key information

Skin sensitisation: not sensitising (QSAR prediction)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
Specific details on test material used for the study:
Cc1cccc(c1)C(=O)O
Key result
Remarks on result:
no indication of skin sensitisation based on QSAR/QSPR prediction

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

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation:

Based on the model outcome “m-toluic acid” is be 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 fulfil requirements for Regulation (EC) No 1907/2006 (REACH) Annex VII section 8.3.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation: not sensitising (QSAR prediction)

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent amendments and corrections, m-toluic acid does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact. m-Toluic acid is not calssified for respiratory sensitisation because of lacking data.