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: 250-437-8 | CAS number: 31024-56-3
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA 102: negative with and without metabolic activation (similar to OECD TG 471) Mammalian cytogenicity (CHO chromosome aberration assay, RA from CAS 157923-74-5: negative with and without metabolic activation (according to OECD TG 473) Mammalian Mutagenicity (HPRT Test, RA from CAS 36957-84-3): negative with and without metabolic activation (similar to OECD TG 476)
Table 1: Test results of experiment 1.
With or without S9-Mix
Test substance concentration
Mean number of revertant colonies per plate
(average of 3 plates ± Standard deviation)
Positive controls, –S9
Mean No. of colonies/plate (average of 3)
Positive controls, +S9
Table 2: Test results of experiment 2.
MMS = methyl methanesulfonate
EMS = ethyl methanesulfonate
9AA = 9-aminoacridine
2-A = 2-anthramine
T = cytotoxic
Data are available from a bacterial mutagenicity study on N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3). No further information is available for the registered substance, however, reliable data are available for the closely related substances, 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) and 2-(triethoxysilyl)propylamine (CAS 36957-84-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of N-[3 -(trimethoxysilyl)propyl]butylamine (CAS 31024 -56 -3). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Discussion of results:
In vitro genotoxicity
In the available key study (Hazleton France, 1989) N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3) was tested for bacterial mutagenicity similar to the OECD TG 471, and in compliance with GLP. No test-substance related increase in the number of revertants was observed when tested in two independent experiments with and without metabolic activation up to the top concentration of 5000 µg/plate in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 in the plate incorporation assay. Appropriate solvent and positive controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
No data are available for mutagenicity to a bacterial strain capable of detecting cross-linking or oxidising mutagens. In view of the lack of genetic toxicity demonstrated in studies on mammalian cells, and the absence of structural features that indicate that such mutagenicity is likely, testing in an appropriate 5th strain is not considered necessary. In addition, the only silicon-containing substance which has given a positive result in a bacterial strain capable of detecting cross-linking or oxidising mutagens contains an epoxy- side-chain (which is associated with cross-linking mutagenicity), and this substance was positive in Salmonella typhimurium strains TA 100, TA 1535 as well as in E.coli WP2uvrA.
In the available key study (RCC, 2001) 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) was tested for cytogenicity according to the OECD TG 473, and in compliance with GLP. The test substance did not induce structural chromosomal aberrations in the Chinese hamster lung fibroblasts (V79) cell line with and without metabolic activation up to limit concentrations. Appropriate solvent and positive controls were included into the test and gave expected results. It is concluded that 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) is negative for the induction of chromosome aberrations under the conditions of the test.
In the available key study (Bushy Run Research Center, 1985) 2-(triethoxysilyl)propylamine (CAS 36957-84-3) was tested for mammalian mutagenicity (HPRT Test) similar to the OECD TG 476, and in compliance with GLP. No increase in mutant frequency was observed at any concentration up to cytotoxicity with and without metabolic activation at 5 hours treatment. Expected results were obtained with positive, solvent, and negative controls. It is concluded that 2-(triethoxysilyl)propylamine (CAS 36957-84-3) is negative for the induction of mutations in Chinese hamster Ovary cells (CHO) under the conditions of the test.
In vivo genotoxicty
No data available.
The available in vitro genotoxicity data are reliable and suitable for classification. Based on this data, classification for mutagenicity according to Regulation (EC)1272/2008 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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again