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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-346-4 | CAS number: 57-68-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on different in vitro genetic toxicity studies Sulfadimidine is not genotoxic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Sulfadimidine did not induce chromosomal aberrations in bone-marrow cells of rats treated in vivo.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Some studies regarding the genetic toxicity of Sulfadimidine are reported in WHO, Toxicological evaluation of Certain Veterinary Drug Residues in Food (WHO Food additives Series 33), 1994 available on website http://www.inchem.org/documents/jecfa/jecmono/v33je07.htm and mentioned also in IARC Monographs, Vol.79, 2001, p.351
In vitro test
- AMES test negative: Sulfadimidine did not induce mutations in Salmonella typhimurium with and without metabolic activationTA100, TA1535, TA1537, TA98 (ref. Mortelmans et all,Environ. Mutagen.,8 (suppl.7):1-119, 1986 mentioned in WHO(1994) and in IARC,2001 indicated at the beginning of this summary)
- HGPRT gene mutation negative: Sulfadimidine did not induce gene mutation at the Hprt locus (at concentrations up to 7 μg/mL) in chinese hamster ovary cell (ref. Young, Mutagenicity test on sulfamethazine, sodium, lot number 860816, in the CHO/HGPRT forward mutation assay. HLA Study 10346-0-435. Test report of Hazleton Laboratories. Submitted to WHO by the Animal Health Institute, Alexandria, VA, USA mentioned in WHO(1994) indicated at the beginning of this summary)
- Unschedule DNA Synthesis in human fibroblasts negative: Sulfadimidine did not induce Unschedule DNA Synthesis in human fibroblasts in culture (ref. Allred et all, J. of Ecotox. and Environm. Health , 10:143-156, 1982 mentioned in WHO(1994) and in IARC,2001 indicated at the beginning of this summary)
- Chromosomal aberrations in Chinese hamster ovary cells negative: Sulfadimidine did not induce Chromosomal aberrations in Chinese hamster ovary cells in Chinese hamster ovary cells at up to 5000 μg/ml with and without metabolic activation (ref. NTP, In vitro cytogenetic tests from SITEK Research Laboratories. Unpublished study submitted to WHO by the National Institute of Environmental Health Sciences, Research Triangle Park,NC, USA. Performed for the US National Toxicology Program, undated mentioned in WHO(1994) indicated at the beginning of this summary)
Sulfadimidine induced sister chromatid exchange in Chinese hamster cells in the absence but not in the presence of an exogenous metabolic system in one experiment (ref. NTP, In vitro cytogenetic tests from SITEK Research Laboratories. Unpublished study submitted to WHO by the National Institute of Environmental Health Sciences, Research Triangle Park,NC, USA. Performed for the US National Toxicology Program, undated mentioned in WHO(1994) and in IARC, 2001 indicated at the beginning of this summary.
In vivo
An in vivo study on genetic toxicity of Sulfadimidine is available: the compound did not induce chromosomal aberrations in bone-marrow cells of rats treated in vivo (ref. Ivett, Chromosomal aberrations in vivo in mammalian bone marrow cells on CL 380. HLA Study no. 10346-0-451. Unpublished report of Hazleton Laboratories, America, Inc. Submitted to the WHO by the Animal Health Institute, Alexandria, VA, USA, 1988 mentioned WHO(1994) and in IARC, 2001 indicated at the beginning of this summary.
Conclusion: All genetic toxicity studies in vitro and in vivo of Sulfadimidine are negative (only sister chromatid exchange in Chinese hamster cells was positive but without metabolic activation). In IARC Monographs, Vol.79, 2001, p.354 Sulfadimidine is considered not to be genotoxic in vitro or in vivo so no classification regarding genetic toxicity is proposed for the substance according to the CLP Regulation (EC n. 1272/2008).
Justification for classification or non-classification
All genetic toxicity studies in vitro and in vivo of Sulfadimidine are negative (only sister chromatid exchange in Chinese hamster cells was positive but without metabolic activation). In IARC Monographs, Vol.79, 2001, p.354 Sulfadimidine is considered not to be genotoxic in vitro or in vivo so no classification regarding genetic toxicity is proposed for the substance according to the CLP Regulation (EC n. 1272/2008).
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.
