Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 938-708-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro
The mutagenic potential of Desmodur RC/100 (TDI Trimer) was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Sutter and Köppe, 2011). Evidence of mutagenic activity was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. Based on this test, the test substance was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
Desmodur RC/100 (TDI Trimer) was tested in an in vitro gene mutation assay in V79 cells (HPRT) according to OECD TG 476 in concentrations up to and including 60 µg/ml, both without and with S9 mix (Hall, 2011). Without and with S9 mix Desmodur RC/100 induced no decreases in survival to treatment or in relative population growth. However, precipitation of the test substance in the culture medium was observed at 15 µg/ml and above. Without and with S9 mix there was no biologically relevant increase in mutant frequency above that of the solvent controls. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Desmodur RC/100 is considered to be non-mutagenic in this HPRT assay.
The clastogenic potential of Desmodur RC/100 (TDI Trimer) was evaluated in a chromosome aberration test on Chinese hamster V79 cells in the presence and absence of S9 mix according to OECD TG 473 (Nebelung, 2011). Without and with S9 mix cytotoxic effects were not observed up to 50 µg/ml after 4 and 18 hours treatment. Precipitation in the medium occurred at 50 µg/ml. None of the cultures treated with Desmodur RC/100 in the absence and in the presence of S9 mix showed biologically relevant or statistically significant increased numbers of aberrant metaphases. Based on this test, Desmodur RC/100 is considered not to be clastogenic for mammalian cells in vitro.
Justification for selection of genetic toxicity endpoint
Only one study available each for Ames test, HPRT test and chromosome aberration test
Short description of key information:
Salmonella/microsome test (Ames test; strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 ): negative (+/- S9 mix)
HPRT test (V79 cells): negative (+/- S9 mix)
Chromosome aberration test (Chinese hamster V79 cells): negative (+/- S9 mix)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the study results (negative in Ames test, HPRT test and chromosome aberration test) a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
