Registration Dossier
Registration Dossier
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EC number: 942-925-0 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Reaction Mass of Zinc, 5,5’-azobis-2,4,6 (1H,3H,5H)-pyrimidinetrione Complexes and Melamine (Azo Zinc Complex Pigment – Melamine compound) shall be registered according to Art 10 of Regulation EC No. 1907 / 2006 (REACH) for annual production of 10 – 100 tons (ANNEX VIII). However, the required toxicological data for information submitted for general registration purposes at this tonnage band are not complete. An accepted method to fill data gaps is by read–across technique. In this case the one-to one approach is chosen.. For this approach nickel, 5,5’-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes and melamine (Azo Nickel Complex Pigment –Melamine Compound, CAS No. 68511-62-6) is chosen.
In addition, there are no specific investigations available on information / assumptions on toxicokinetics. These data are derived from available studies in animals.
Key value for chemical safety assessment
Additional information
Justification for Read Across to fill the data gaps
Reaction Mass of Zinc, 5,5’-azobis-2,4,6 (1H,3H,5H)-pyrimidinetrione Complexes and Melamine (Azo Zinc Complex Pigment – Melamine compound) shall be registered according to Art 10 of Regulation EC No. 1907 / 2006 (REACH) for annual production of 10 – 100 tons (ANNEX VIII). However, the required toxicological data for information submitted for general registration purposes at this tonnage band are not complete. Studies required for this tonnage band are a genotoxicity test in mammalian cells and screening reproductive toxicity data.
According to ECHA Document: Guidance on information requirements and chemical safety assessment volume R 6: QSARs and grouping of chemicals (2008) section.2.3 p.89 and Practical Guide No. 6 (2012) an accepted method to fill data gaps is by read–across technique. Read across can be performed by different ways. In this case the one-to one approach is chosen.
For this approach nickel, 5,5’-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes and melamine (Azo Nickel Complex Pigment –Melamine Compound, CAS No. 68511-62-6) is chosen.
Reaction Mass of Zinc, 5,5’-azobis-2,4,6 (1H,3H,5H)-pyrimidinetrione Complexes and Melamine (Azo Zinc Complex Pigment – Melamine compound) shall be registered according to Art 10 of Regulation EC No. 1907 / 2006 (REACH) for annual production of 10 – 100 tons (ANNEX VIII). However, the required toxicological data for information submitted for general registration purposes at this tonnage band are not complete as shown in table 1. The most important gaps are the lack of a genotoxicity test in mammalian cells and the lack of fertility data required for this tonnage band. As surrogate compound Azo Nickel Complex Pigment Melamine Compound is proposed.
Comparing the physico-chemical data and the available toxicological data the similarity of both compounds was demonstrated. Both compounds are not bioavailable and, consequently, no toxicity is observed in any toxicological experiment up to the limit dose . Thus, Azo Nickel Complex Pigment Melamine Compound is the adequate compound to be used for read across with Azo Zinc Complex Pigment – Melamine compound and to introduce the studies (HPRT test and the Developmental toxicity study) of Azo Nickel Complex Pigment Melamine Compound as surrogates for the missing data of Azo Zinc Complex Pigment Melamine Compound.
In conclusion, based on these considerations, the requirements of Regulation EC No. 1907/2006 for an annual production volume of 10 - 100 tons of Azo Zinc Complex Pigment – Melamine compound are fulfilled.
Statement on Toxicokinetics
There are no experimental toxicokinetic data with Reaction Mass of Zinc, 5,5’-azobis-2,4,6 (1H,3H,5H)-pyrimidinetrione Complexes and Melamine (Azo Zinc Complex Pigment – Melamine Compound) available. The following remarks on toxicokinetics of Azo Zinc complex Pigment – Melamine compound are therefore based on the available studies which were compiled in the respective IUCLID database. These assumptions follow the procedure indicated in the “Guidance on information requirements and chemical safety assessment chapter R.7c” of the ECHA guidance document (version 2.0, November 2014).
Based on the available data from oral and dermal application absorption might be low. No information is available from absorption via respiratory tract. Following oral application the distribution is limited because no mortality , no clinical signs and no gross or histological lesions were noted. Due to the negative result in the available in-vitro genotoxicity studies it is assumed that at least no DNA reactive metabolites will be generated. There is no special study available but from the discolored feces during treatment it can be assumed that this is the preferred excretion route.
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.
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