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Endpoint summary

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
according to
Guideline:
other: estimated data
Principles of method if other than guideline:
QSAR prediction is done using QSAR toolbox version 2.3
GLP compliance:
not specified
Type of study:
Draize test
Species:
rabbit
Strain:
not specified
Sex:
male/female
Clinical observations:
Negative
Remarks on result:
other: Clinical observations: Negative.





The prediction was based on dataset comprised from the following descriptors: "Skin sensitisation"
Estimation method: Taking highest mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and "b" ) and ("c" and "d" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(N(C)C)ccc(C)cc1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Similarity boundary:Target: c1(N(C)C)ccc(C)cc1
Threshold=80%,
Dice(Atom pairs)

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.25

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.71

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the QSAR prediction done for N,N-dimethyl-p-toluidine for skin sensitization it was estimated that N,N-dimethyl-p-toluidine is not sensitizing to skin of rabbit.
Executive summary:

Based on the QSAR prediction done for N,N-dimethyl-p-toluidine for skin sensitization it was estimated that N,N-dimethyl-p-toluidine is not sensitizing to skin of rabbit.

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

Based on studies of target substance CAS NO 99-97-8 and read across reviewed for skin sensitization from reliable sources having Klimisch rating 2also from category based on organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox considering the weight of evidence approach.

 The summary of the results are presented below

Sr. No

End point

effect

Species

Remark

1

Skin sensitization

Not sensitizing

Rabbit

Predicted data of target chemical

 

2

Skin sensitization

Not sensitizing

guinea pig

Data is from publication for CAS NO 91-66-7

 

Based on results summarized in above table for the target chemical CAS NO 99-97-8 and read across, it can be concluded that the substance is not sensitizing to the skin of rabbit and guinea pig.Thus N,N-dimethyl-p-toluidine is considered to be not sensitizing to skin as per the CLP criteria

Migrated from Short description of key information:
The substance N,N-dimethyl-p-toluidine is not a skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Based on the QSAR prediction done for N,N-dimethyl-p-toluidine for skin sensitization it was estimated that N,N-dimethyl-p-toluidine is not sensitizing to skin of rabbit.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance N,N-dimethyl-p-toluidine is not sensitizing skin rabbit and guinea pig and hence not classified as sensitizing s per CLP criteria