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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Remarks:
(Q)SAR
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
SOFTWARE
QSAR DYES R&C
Report produced by version QSAR dyes R&C 2.0
Developed by Milano Chemometrics and QSAR Research Group, Dept. Earth and Environmental Sciences, University Milano-Bicocca, Italy.
Details about the tool are included into the attachment.

Data source

Reference
Reference Type:
other: (Q)SAR model
Title:
Unnamed
Year:
2016

Materials and methods

Principles of method if other than guideline:
QSAR Prediction. Details on the QSAR model used are reported in the attachment (i.e. (Q)SAR model reporting (QMRF)).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Dose descriptor:
other: (Q)SAR prediction
Remarks on result:
other: no concern for acute oral toxicity is identified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The substance is expected to have no concern for acute oral toxicity, on basis of the estimation.
Executive summary:

The acute oral toxicity of the substance was investigated using a specific QSAR model, developed to predict the acute oral toxicity for dyes. The existing QSAR models have strong limitations to predict ionic complex structures as the organic dyes are, and consequently they provide unreliable results. The QSAR modelling was developed in accordance with the OECD principles (details in the documentation attached).

Based on the estimation, the substance is expected to have no concern for acute oral toxicity. The estimation resulted to be in the applicability domain of the model.

Thus, the substance can be considered as not classified for acute oral toxicity.