Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
An OECD TG 473 in vitro test has been conducted to determine the possible clastogenicity of dilithium tetraborate using cultured human lymphocytes. Both in the absence and presence of S9-mix, dilithium tetraborate did not induce any statistically significant and biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments.
In an OECD TG 471 in vitro study, dilithium tetraborate induced dose related increases in tester strain TA100 (Salmonella typhimurium) in the absence and presence of S9-mix in two independent experiments (2.0 and 2.3-fold), respectively. The results in TA100 are therefore considered equivocal.
An OECD TG 490 in vitro study, was conducted to evaluate the mutagenic potential of Dilithium tetraborate by testing its ability to induce forward mutations at the thymidine kinase (TK) locus in L5178Y mouse lymphoma cells, either in the absence or presence of a metabolic system (S9-mix). Negative in vitro results for mutagenicity in mammalian cells were obtained for dilithium tetraborate.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
Read-across to these results are proposed for Reaction products of boric acid and calcium dihydroxide and lithium hydroxide since at physiological pH, it will dissociate and release boric acid and lithium/calcium ions as a result of relevant transformation pathways. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes to the results.
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:
- The UVCB - Reaction products of boric acid and calcium dihydroxide and lithium hydroxide (EC # 701-453-3) has structural similarities to two already established categories: lithium salts of the oxyacids of boron (B); and calcium salts of the oxyacids of boron (B). Dilithium tetraborate (EC# 234-514-3) (source substance #1) and calcium metaborate (EC# 237-224-5) (source substance #2) will be used to predict the properties for the target substance.
At physiological pH, all category members dissociate and release boric acid and lithium/calcium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The bacterial lawn was slightly reduced
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The bacterial lawn was slightly reduced
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- 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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- 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
- 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
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- 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
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- 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:
- Remarks:
- Note: The number of revertant colonies was within the historical control data for all concentrations
- Conclusions:
- The test item induced dose related increases in tester strain TA100 in the absence and presence of S9-mix in two independent experiments (2.0 and 2.3-fold), respectively. The number of revertant colonies was within the historical control data range for all concentrations, with the exception of the highest concentration in the presence of S9-mix which was just above the historical control data range. The test result was equivocal in tester strain TA100 of the Salmonella typhimurium reverse mutation assay. However, the test item was not mutagenic in the other Salmonella typhimurium tester strains (TA1535, TA1537 or TA98) or the Escherichia coli reverse mutation assay using strain WP2uvrA.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
Read-across to these results are proposed for Reaction products of boric acid and calcium dihydroxide and lithium hydroxide since at physiological pH, it will dissociate and release boric acid and lithium/calcium ions as a result of relevant transformation pathways. The same mutagenic effects are therefore expected. - Executive summary:
An Ames test was conducted to determine the potential of dilithium tetraborate and/or its metabolites up to concentrations of 5000 µg/plate to induce reverse mutations at the histidine locus in several strains of Salmonella typhimurium (S. typhimurium; TA98, TA100, TA1535, and TA1537), and at the tryptophan locus of Escherichiacoli (E. coli) strain WP2uvrA in the presence or absence of an exogenous mammalian metabolic activation system (S9). The test result was equivocal in tester strain TA100 of the Salmonella typhimurium reverse mutation assay. However, the test item is not mutagenic in the other Salmonella typhimuriumtester strains (TA1535, TA1537 or TA98) or the Escherichia coli reverse mutation assay using strain WP2uvrA.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
Read-across to these results are proposed for for Reaction products of boric acid and calcium dihydroxide and lithium hydroxide since at physiological pH, it will dissociate and release boric acid and lithium/calcium ions as a result of relevant transformation pathways. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes to the results. As the results were equivocal, a testing proposal is submitted for dilithium tetraborate for further investigations of the mutagenic effect of these lithium borates.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The UVCB - Reaction products of boric acid and calcium dihydroxide and lithium hydroxide (EC # 701-453-3) has structural similarities to two already established categories: lithium salts of the oxyacids of boron (B); and calcium salts of the oxyacids of boron (B). Dilithium tetraborate (EC# 234-514-3) (source substance #1) and calcium metaborate (EC# 237-224-5) (source substance #2) will be used to predict the properties for the target substance.
At physiological pH, all category members dissociate and release boric acid and lithium/calcium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- lymphocytes: Humans
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- An in vitro test has been conducted to determine the possible clastogenicity of dilithium tetraborate. Both in the absence and presence of S9-mix Dilithium tetraborate did not induce any statistically significant and biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
Therefore similar results are expected for Reaction products of boric acid and calcium dihydroxide and lithium hydroxide. - Executive summary:
The UVCB - Reaction products of boric acid and calcium dihydroxide and lithium hydroxide (EC # 701-453-3) has structural similarities to two already established categories: lithium salts of the oxyacids of boron (B); and calcium salts of the oxyacids of boron (B). Dilithium tetraborate (EC# 234-514-3) (source substance #1) and calcium metaborate (EC# 237-224-5) (source substance #2) will be used to predict the properties for the target substance.
At physiological pH, all category members dissociate and release boric acid and lithium/calcium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
Negative in vitro results for clastogenicity (chromosome aberration) were obtained for dilithium tetraborate therefore similar negative results are expected for Reaction products of boric acid and calcium dihydroxide and lithium hydroxide. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in the genetic toxicity.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
On the basis of the equivocal results obtained in the bacterial reverse mutation assay (OECD TG 471) further testing is proposed. A classification is not currently proposed.
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.
