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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
Spetember 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source
Justification for type of information:
Refer to the attachment.
Concerning developmental toxicity, 2,4,6 trimethylphenol falls in the applicability domain of two models included in Danish QSAR database (CASE Ultra and SciQSAR).
Details on Danish QSAR database are available from the weblink: http://qsar.food.dtu.dk/

Data source

Reference
Reference Type:
other: expert system report
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Guideline:
other: REACH Guidance on QSARs R.6

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Oc(c(cc(c1)C)C)c1C

Test animals

Species:
other: In silico prediction for teratogenic potential in humans

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
other: In silico prediction for teratogenic potential in humans from Danish QSAR database expert system.

Results (fetuses)

Effect levels (fetuses)

Remarks on result:
other: In silico prediction for teratogenic potential in humans from Danish QSAR database expert system.

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

From Danish QSAR database report, for this end-point 2,4,6 trimethylphenol falls in the applicability domain of the models CASE Ultra and SciQSAR. Qualitative results were obtained. Negative result concerning

teratogenic potential in human is provided by CASE Ultra. instead a positive result concerning developmental effects is provided by SciQSAR.

Applicant's summary and conclusion

Conclusions:
From Danish QSAR database report, for this end-point 2,4,6 trimethylphenol falls in the applicability domain of the models CASE Ultra and SciQSAR. Qualitative results were obtained.
Negative result concerning developmental effects is provided by CASE Ultra.
instead a positive result concerning developmental effects is provided by SciQSAR.