Registration Dossier
Registration Dossier
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EC number: 943-893-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity (mutagenicity) in bacterial cells (OECD 471, GLP): negative in TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA with and without metabolic activation (RA CAS 68684-55-9)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Source: CAS 68684-55-9, 7.6.1
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the source substance (CAS 68684-55-9) did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Based on the analogue approach, same results are expected for the target substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no data available on the genetic toxicity in bacterial cells for Reaction mass of 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-{2-[hydroxy(phosphonooxy)-phosphinyl]oxyethyl]-thiazoliumchlorid and 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-(2-phosphonooxyethyl)- thiazoliumchlorid-Dihydrat (EC 943-893-0). Read-across from the source substance 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazoniol-5-yl]ethyl dihydrogen diphosphate tetrahydrate (CAS 68684-55-9) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.4. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Genetic toxicity in bacteria
CAS 68684-55-9
Mutagenicity of 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazoniol-5-yl]ethyl dihydrogen diphosphate tetrahydrate (CAS 68684-55-9) was tested in a bacterial reverse mutation assay performed according to OECD guideline 471 and under GLP conditions (reference 7.6.1-1). The assay was performed with a standard battery of Salmonella typhimurium tester strains including TA 1535, TA 1537, TA 98 and TA 100, and Escherichia coli WP2uvrA, with and without metabolic activation. The highest concentration of 5000 µg/plate was tested in all bacterial strains. The test substance did not exhibit mutagenic properties in the absence or presence of metabolic activation. Toxicity indicated by reduced number of revertants was not observed in any tester strains in the applied concentration range (from 3 to 5000 µg/plate using the plate incorporation method and from 33 to 5000 µg/plate using the pre-incubation method). The positive control substances induced a distinct increase in the number of revertants in all strains with and without metabolic activation thereby showing the validity of the assay. The solvent control was also shown to be valid.
Based on the results of the conducted study, 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazoniol-5-yl]ethyl dihydrogen diphosphate tetrahydrate (CAS 68684-55-9) is not considered to exhibit mutagenic properties in bacterial cells and thus the same is assumed for the target substance.
Furthermore, data on cytogenicity and mutagenicity in mammalian cells was available for the source substance, Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]- (CAS 10023-48-0), which were not included in the dossier, since according to the data requirements specified in Annex VII of Regulation (EC) No 1907/2006, data on cytogenicity and mutagenicity in mammalian cells is not required for the tonnage band 1 - 10 t/a. The available data with 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-thiazolium (CAS 10023-48-0) revealed no mutagenic and clastogenic properties in V79 cells and in cultured peripheral human lymphocytes, respectively (reference 7.6.1-2 and 7.6.1-3, registration dossier 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-thiazolium).
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Reaction mass of 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-{ 2-[hydroxy(phosphonooxy)-phosphinyl]oxyethyl]-thiazoliumchlorid and 3-[( 4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-(2-phosphonooxyethyl)- thiazoliumchlorid-Dihydrat (EC 943-893-0), data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Based on the available data on genetic toxicity, there is no indication that the source substance 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazoniol-5-yl]ethyl dihydrogen diphosphate tetrahydrate (CAS 68684-55-9) induces genetic toxicity in bacteria. Moreover, the available data with Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]- (CAS 10023-48-0) revealed no mutagenic and clastogenic properties in V79 cells and in cultured peripheral human lymphocytes, respectively. Based on the analogue approach, the same results were expected for the target substance. The available data do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and 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.
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