[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

Description of key information

To assess the repeated dose toxicity of the substance with CAS 2218502-12-4 (Direct Black 168 NaLi salts), an in vivo study conducted on the similar substance (read-across) with CAS 93281-13-1(Direct Black 168 NaLi) has been chosen. The observations of the study, conducted according to OECD 422 GLP compliant, support that the substance is not classified for toxicity following repeated dose oral route. Based on the study outcomes, the dose level of 350 mg/kg bw/day was considered as an appropriate No Observed Adverse Effect Level to be used for the Chemical Safety Assessment and DNEL derivation of the source substance.

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.

Based on exposure considerations and the available toxicological information, testing in a 28-days by oral route, has been considered sufficient and the dermal study on repeated dose does not need to be conducted.

The repeated dose inhalation study does not need to be conducted because the exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance.

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

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 in section 13 "Other reports"

Reason / purpose for cross-reference:

read-across source

Dose descriptor:

NOAEL

Effect level:

>= 350 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Remarks on result:

not determinable due to absence of adverse toxic effects

Critical effects observed:

no

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

350 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of repeated oral exposure study, the observed effects at the observed concentrations are considered not to support classification for specific target organ toxicity following repeated exposure, and the substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC).