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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Ro 31 -9373/000 was tested in four strains of S. typhimurium (TA97, TA98, TA100 and TA102) in a standard plate incorporation and pre-inubation modification of the Ames test for mutagenic activity. The test material was disolved in DMSO and administered at concentrations ranging from 50 to 5000 ug/plate, in the presence or absence of metabolic activation in the form of rat liver induced S-9. Ro 31 -9373/000 was not toxic up to the maximal concentration tested in the standard plate incorporation assay but signs of toxicity were evident in the pre-incubation assay at 1666 ug/ml.

No increase in the his+ revertants was evident, PTH-decahydroamide was not found to be mutagenic under the conditions of this assay.

In a replicated assay to determine the effects of PTH-decahydroamide on the induction of chromosomal aberrations in cultured peripheral human lymphocytes, cultures were prepared with or without metabolic activation (rat liver S-9 mix) and tested using concentrations of up to 1000 ug/ml for 24 or 48 hour fixation periods. None of the concentrations evaluated gave a postive response under the test conditions. Vehicle and positive control cultures gave responses consistent with historical ranges and met the acceptance criteria for the assay. PTH-decahydroamide was not clastogenic under the conditions of this assay.

Short description of key information:
Negative responses are seen in an Ames test and a study of clastogencity in human pepripheral lymphocytes in vitro. Studies were performed in the presence and absence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Both in vitro studies - a clastogenicity investigation with human cultured peripheral lymphocytes and an Ames test using four strains of S.typhimurium - gave negative responses for mutagenicity. No classification is warranted for PTH-decahydroamide based on the available data.