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EC number: 236-860-0 | CAS number: 13518-93-9
No studies are available with diphosphoric acid, compound with 1,3,5 -triazine-2,4,6 -triamine (1:2). However, reliable data are available for the structrual analogue substance 1,3,5 -triazine-2,4,6 -triamine (CAS 108 -78 -1).
OECD 414 (RL1, rat, oral, RA-CAS 108 -78 -1): NOAEL maternal = 4500 ppm (ca. 400 mg/kg bw/day); NOAEL developmental = 15000 ppm (ca. 1060 mg/kg bw/day)
There are no data available on developmental toxicity of diphosphoric acid, compound with 1,3,5 -triazine-2,4,6 -triamine (CAS 13518 -93 -9). In order to fulfil the standard information requirements set out in Annex VII, 8.3., in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
A reliable developmental toxicity study according to OECD 414 and GLP is available with the source substance 1,3,5-triazine-2,4,6-triamine (melamine, CAS 108-78-1) (BASF 1996). Melamine was tested for its prenatal toxicity in Wistar rats (BASF 1996). The test substance was administered as a constant homogeneous addition to the food to 23 – 24 pregnant female rats/group at concentrations of 1500, 4500 and 15,000 ppm (136; 400; 1060 mg/kg bw/day) on day 6 through day 16 post coitum. Under the conditions of this study, the administration of melamine to pregnant female rats during organogenesis elicited signs of maternal toxicity at 15,000 ppm. Maternal toxicity was substantiated by reduced food consumption, impairments in body weight/body weight gain, decreased corrected body weight gain and clinical symptoms like haematuria, indrawn flanks and piloerection. Nearly all signs of maternal toxicity proved to be fully reversible after cessation of the test substance administration. The carcass weight and the corrected body weight gain, however, showed still some impairment at terminal sacrifice. There were no substances related findings on the gestational parameters and no signs of developmental toxicity up to and including 15,000 ppm (ca. 1060 mg/kg bw/day, highest dose). Especially no indications of teratogenicity were found. Based on these results a NOAEL for maternal toxicity was set to 4500 ppm (400 mg/kg bw/day) and a NOAEL for developmental toxicity was set to 15,000 ppm (1060 mg/kg bw/day). Based on the above study results with the structural analogue substances melamine (CAS 108-78-1) sufficient evidence is given that the registered substance diphoshoric acid, compound with 1,3,5-triazine-2,4,6-triamine 1:2 (CAS 13518-93-9) is considered not to have developmental toxicity potential.
Reliable data from a structural analogue on reproductive toxicity indicates that the registered substance does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and the available data are therefore conclusive but not sufficient for classification.
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.
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