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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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 Disulfo copper phthalocyanine amine salt. The study assumed the use of Salmonella typhimurium strain TA100 with S9 metabolic activation system. Disulfo copper phthalocyanine amine salt failed to induce mutation in Salmonella typhimurium strain TA100 with S9 metabolic activation system and hence is predicted to not classify for gene mutation 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 K2 prediction database and the supporting QMRF has been attached
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.4
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of the test material: Disulfo copper phthalocyanine amine salt
- Molecular formula: C32H14CuN8O6S2.2Na
- Molecular weight: 780.1706 g/mol
- Substance type: Organic
Target gene:
Histidine
Species / strain:
S. typhimurium TA 100
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with
Metabolic activation system:
S9 metabolic activation system
Test concentrations with justification for top dose:
No data
Vehicle:
No data
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and conditions:
No data
Rationale for test conditions:
No data
Evaluation criteria:
The plates were observed for a dose dependent increase in the number of revertants/plate
Statistics:
No data
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Additional information on results:
No data
Conclusions:
Disulfo copper phthalocyanine amine salt failed to induce mutation in Salmonella typhimurium strain TA100 in the presence of S9 metabolic activation system and hence dose not classify for gene mutaton 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 Disulfo copper phthalocyanine amine salt. The study assumed the use of Salmonella typhimurium strain TA100 with S9 metabolic activation system. Disulfo copper phthalocyanine amine salt failed to induce mutation in Salmonella typhimurium strain TA100 with S9 metabolic activation system and hence is predicted to not classify for gene mutation 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 two read across chemicals have been reviewed and summarized to determine the mutagenic nature of

Disulfo copper phthalocyanine amine salt:

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 Disulfo copper phthalocyanine amine salt. The study assumed the use of Salmonella typhimurium strain TA100 with S9 metabolic activation system and strain TA1535 without S9 metabolic activation system. Disulfo copper phthalocyanine amine salt failed to induce mutation in Salmonella typhimurium strain TA100 with S9 metabolic activation system and strain TA1535 without S9 metabolic activation system and hence is predicted to not classify for gene mutation in vitro.

Gene mutation study was conducted by Milvy et al (Journal of Toxicology and Environmental Health, 1978) to evaluate the mutagenic nature of structurally and functionally similar read across chemical Phthalocyanine blue (RA CAS no 147 -14 -8; IUPAC name: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper). The study was performed using the preincubation protocol using Salmonella typhimurium TA98, TA1538 and TA1535 both in the presence and absence of S9 metabolic activation system.10 µg of the dye partially or completely dissolved in 0.01 ml of dimethyl sulfoxide (DMSO) was added to 0.9 ml of the reagents in the liquid phase and incubated 30 min at 37°C with shaking before plating 0.1 ml onto minimal plates. Consurrent solvent and positive controls were included in the study. Phthalocyanine blue failed to induce mutation in Salmonella typhimurium TA98, TA1538 and TA1535 in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.

In the same study by Milvy et al (Journal of Toxicology and Environmental Health, 1978), Spot test was also conducted to evaluate the mutagenic nature of Phthalocyanine blue (RA CAS no 147 -14 -8; IUPAC name: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper). The study was performed using Salmonella typhimurium TA98, TA1538 and TA1535 both in the presence and absence of S9 metabolic activation system. Phthalocyanine blue failed to induce mutation in the Salmonella typhimurium TA98, TA1538 and TA1535 in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.

Based on the information observed for the test chemical and its various read across, it is summarized that Disulfo copper phthalocyanine amine salt

is not likely to exhibit genetic toxicity. Thus, the chemical is not classified as a genetic toxicant as per as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the weight of evidence data summarized, Disulfo copper phthalocyanine amine salt (CAS no 1328 -51 -4) is not likely to exhibit genetic toxicity. Thus, the chemical is not classified as a genetic toxicant.