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REACH

Disodium 8-hydroxynaphthalene-1,6-disulphonate

EC number: 280-631-8 | CAS number: 83732-80-3

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3). The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without S9 metabolic activation system. Disodium 8-hydroxynaphthalene-1,6-disulfonate was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro. Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

Link to relevant study records

Reference

Endpoint:: in vitro gene mutation study in bacteria
Type of information:: (Q)SAR
Adequacy of study:: weight of evidence
Reliability:: 2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:: results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:: Data is from OECD QSAR Toolbox version 3.4 and the supporting QMRF report has been attached
Qualifier:: according to guideline
Guideline:: other: As mention below
Principles of method if other than guideline:: Prediction is done using OECD QSAR Toolbox version 3.4, 2017
GLP compliance:: not specified
Type of assay:: bacterial reverse mutation assay
Specific details on test material used for the study:: - Name of test material (IUPAC name): Disodium 8-hydroxynaphthalene-1,6-disulfonate
- Molecular formula: C10H6Na2O7S2
- Molecular weight: 348.2624 g/mol
- Smiles notation: c1cc2cc(cc(c2c(c1)S(=O)(=O)[O-])O)S(=O)(=O)[O-].[Na+].[Na+]
- InChl: 1S/C10H8O7S2.2Na/c11-8-5-7(18(12,13)14)4-6-2-1-3-9(10(6)8)19(15,16)17;;/h1-5,11H,(H,12,13,14)(H,15,16,17);;/q;2*+1/p-2
- Substance type: Organic
- Physical state: Solid
Target gene:: Histidine
Species / strain / cell type:: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Details on mammalian cell type (if applicable):: Not applicable
Additional strain / cell type characteristics:: not specified
Cytokinesis block (if used):: not specified
Metabolic activation:: with
Metabolic activation system:: S9 metabolic activation
Test concentrations with justification for top dose:: not specified
Vehicle / solvent:: not specified
Untreated negative controls:: not specified
Negative solvent / vehicle controls:: not specified
True negative controls:: not specified
Positive controls:: not specified
Details on test system and experimental conditions:: not specified
Rationale for test conditions:: not specified
Evaluation criteria:: Prediction is done considering a dose dependent increase in the number of revrtants/plate
Statistics:: not specified
Species / strain:: S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:: with
Genotoxicity:: negative
Cytotoxicity / choice of top concentrations:: not specified
Vehicle controls validity:: not specified
Untreated negative controls validity:: not specified
Positive controls validity:: not specified
Remarks on result:: other: No mutagenic effect were observed
Conclusions:: Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3)was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.
Executive summary:: Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3). The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with S9 metabolic activation system. Disodium 8-hydroxynaphthalene-1,6-disulfonate was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro. Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:: no study available

Additional information

Gene mutation in vitro;

Prediction model based estimation and data from read across chemical have been reviewed to determine the mutagenic nature of Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3). The studies are as mentioned below

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3). The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without S9 metabolic activation system. Disodium 8-hydroxynaphthalene-1,6-disulfonate was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro. Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, chromosomal aberration was predicted for Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3).The study assumed the use of Chinese hamster ovary (CHO) cell line with and without S9 metabolic activation system Disodium 8-hydroxynaphthalene-1,6-disulfonate was predicted to not induce chromosomal aberrations in Chinese hamster ovary (CHO) cell line in the presence and absence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro. Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Errol Zeiger et al.( Environmental and Molecular Mutagenesis,1992) to determine the mutagenic nature of Ponceau SX (C.I. Food Red 1); IUPAC name: disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate (4548-53-2). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. Genetic toxicity test was performed by Ponceau SX onS typhimurium(Strain TA100, TA98, TA97 and TA 1535).Initial testing was in strain without activation and with 30% rat and hamster S-9. If a positive response was obtained in one or both strains, only the positive test condition was repeated. Each chemical was initially tested in the preincubation test at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one that was toxic in the preliminary toxicity procedure.The test chemical (0.05 ml), overnight culture of Salmonella (0.10 ml at CWR and MIC, and 0.05 ml at SRI), and S-9 mix or buffer (0.50 ml), were incubated at 37◦C, without shaking, for 20 min.At least five doses of each chemical were tested in triplicate, and repeat experiments were performed at least one week following the initial trial.A maximum of 0.05 ml solvent was added to each plate.Different concentrations used are 0, 1, 3.10, 33, 100, 333, 1000, 3333, 10000, µg/plates.X A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response. No mutagenic effect were observed .From the experiment on Salmonella typhimurium Strain TA100, TA98, TA97 and TA 1535)it was concluded that the Ponceau SX(CAS No 4548-53-2) was genetically non-toxic chemical with and without activation.

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by R.B. Haveland-Smith et al.( Mutation Research, 1979) to determine the mutagenic nature of Red 2G; IUPAC Name;disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate (3734-67-6). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. In a mutagenicity test, the mutagenic effect of Red 2G was evaluated in Salmonella typhimurium strain TA1538 utilizing a Fluctuation test. The bacteria were exposed to the test compound at the concentration of 1 or 10 mg /ml in presence or absence of metabolic activation. At the end of the study, the tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the color. In this case, the presence of viable prototrophic revertants was verified by streaking loopfuls from each tube onto non-supplemented agar. As seen by the results, no mutagenic effects of Red 2G were found at 1 or 10 mg/ml in the absence or presence of metabolic activation. Hence, Red 2G is considered to be negative for mutagenic effects in Salmonella typhimurium strain TA1538 with and without metabolic activation.

Based on the data available for the target chemical and its read across substance and applying weight of evidence Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for the target chemical Disodium 8-hydroxynaphthalene-1,6-disulfonate (83732-80-3)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

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