[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

To assess the genetic toxicity in vitro of the substance with CAS 2218502-12-4 (Direct Black 168 NaLi salts), relevant in vitro studies conducted on the similar substance (read-across) with CAS 93281-13-1(Direct Black 168 NaLi) have been chosen.

The outcome of the studies with the source substance showed that it induced point mutations by frameshifts in the genome of strain TA1538; indication of a possible mutagenic response has also been recorded in strain TA1537. The substance did not induce structural chromosome aberrations in the V79 Chinese hamster cell line.

Based on the structural similarity, the same behaviour of the target substance could be expected. Both substances CAS 218502-12-4 (Direct Black 168 NaLi salt) and CAS 93281-13-1 (Direct Black 168 Na salt) have the same organic anionic structure. The differences are considered to be not able to impact the study outcome, thus the read-across can be considered as reliable and appropriate to evaluate the endpoint. Details on read-across approach are given in the section 13 of IUCLID file.

 

Link to relevant study records

Reference

Endpoint:

genetic toxicity in vitro, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

See the report for the analogue approach justification in section 13 "Other reports"

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

In conc. higher tan 1 microg/ml (without S9 mix) and 30 microg/ml (with S9 mix)

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with

Genotoxicity:

ambiguous

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

To assess the genetic toxicity in vivo of the substance with CAS 2218502-12-4 (Direct Black 168 NaLi salts), relevant in vivo studies conducted on the similar substance (read-across) with CAS 93281-13-1(Direct Black 168 NaLi) have been chosen.

The outcome of the studies with the source substance showed that it did not induce micronulei in the bone narrow cells of the mouse and dit not induce DNA-damage leading to repair synthesis in the hepatocytes of the treated rats.

Based on the structural similarity, the same behaviour of the target substance could be expected. Both substances CAS 218502-12-4 (Direct Black 168 NaLi salt) and CAS 93281-13-1 (Direct Black 168 Na salt) have the same organic anionic structure. The differences are considered to be not able to impact the study outcome, thus the read-across can be considered as reliable and appropriate to evaluate the endpoint. Details on read-across approach are given in the section 13 of IUCLID file.

 

Link to relevant study records

Reference

Endpoint:

genetic toxicity in vivo, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

See the report for the analogue approach justification in section 13 "Other reports"

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

slight toxic reactions

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Remarks on result:

other: unscheduled DNA synthesis

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

Following the criteria as described in Annex 1 of Regulation (EC) No. 1272/2008, and based on the available data, the substance is not classified for genetic toxicity