disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate

Endpoint summary

Description of key information

In rats, LD50 > 2000 mg/kg bw after oral and dermal exposure to test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

As for the oral route, acute toxicity of the substance was tested on rats. The parameters observed at periodic intervals up to day 15 were mortality, clinical signs, body weights and macroscopic findings after necropsy at day 15.

The results are reported: no deaths occurred during the study period; no clinical signs of systemic toxicity were seen, the only sign noted was local alopecia in the right cheek of 3 males, but this was not considered as toxicologically relevant; no relevant changes in body weights were noted; at post mortem examination no significant changes were noted.

Acute toxicity upon dermal exposure was tested in rats. The parameters observed at periodic intervals up to day 15 were: mortality; body weights; clinical signs, focusing on general behaviour, respiration, eye, nose, motility, body posture, motor susceptibility, skin and other possible signs; macroscopic findings after necropsy at day 15.

The results are reported: no deaths occurred during the study period; no clinical signs of systemic toxicity were seen, the only sign noted was red discoloration of the skin in all treated animals (5 males and 5 females) at 2000 mg/kg bw dose; no relevant changes in body weights were noted; no organ abnormalities at post mortem examination.

The inhalation route was not tested due to the physical features of the substance, that suggest a minimal probability of systemic exposure by this route. In particular, the substance has a negligible vapour pressure, thus being unlikely available for inhalation as a vapour. Moreover, it has a mass median diameter between 63 - 250 µm, thus indicating that only a small fraction may be inhaled by nose and mouth; whereas, the respirable fraction of particles, i.e. diameter < 4 µm, is less than 4 %.

According to the CEN document, EN 481 ‘Workplace Atmospheres – size fraction definitions for measurement of airborne particles’ (CEN 1993), particles above 100 µm are not inhalable.

Under the test conditions, during the observation period, the substance did not induce systemic toxicity.

Justification for selection of acute toxicity – oral endpoint
The study is reliable and representative.

Justification for selection of acute toxicity – dermal endpoint
The study is reliable and representative.

Justification for classification or non-classification

The threshold of classification for oral and dermal acute toxicity according to the CLP Regulation (EC 1272/2008) is a LD50 value of 2000 mg/kg bw. By considering both the exposure routes, no deaths occurred up to the highest testes dose of 2000 mg/kg bw. Thus, no classification is required since the LD50 of the substance is above the classification range.