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

The substance resulted as non-toxic in a subacute (28 days) study in rats administered orally by gavage.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 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

Additional information

Subacute toxicity was tested in rats of both sexes orally by gavage at concentrations of 0, 50, 200 and 1000 mg/kg bw/day. At the end of the treatment period, a 14 -day treatment-free recovery period was given to half of the animals in the control and high dose group.

At all tested doses there were no substance related deaths or clinical signs of reaction to treatment and no effects on food consumption or body weight. Moreover, no abnormal findings were noted in ophtalmoscopic examinations and organ weights. The assessment of hematological, clinical biochemical and urinalysis data indicated a single change of note, namely an increase in ASAT and ALAT activity in female rats at the highest dose. However, this finding was reversible within the 14 -day recovery period and has no toxicological significance.

At macroscopical and microscopical examination, no morphologic alterations indicating a toxicity of the substance were found. However, at 1000 mg/kg bw/day various segments of the intestinal tract were discolored by test substance and one red-brown discoloration was noted in the lungs of one rat. At histopathologic examination, this was attributed to multifocal macrophage accumulations which contained dyestuff particles. This was also noted in another rat and was presumed to be due to accidental inhalation of the test article. All other microscopic findings recorded were within the range of background pathology encountered in rats of this age and strain and occurred at similar incidences and severity in both control and treated rats.

Under test conditions, during the observation period, the substance appeared as devoid of systemic toxicity.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study is reliable and representative.

Justification for classification or non-classification

The substance is not classified according to the CLP Regulation (EC 1272/2008). In a subacute (28 days) toxicity study in rats by oral exposure, a no-observed adverse effect level (NOAEL) of 1000 mg/kg bw/day was found, which is far above the threshold of classification of 300 mg/kg bw/day.