1,5-Naphthalenedisulfonic acid, 2-[2-[8-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:5)

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The read across studies have been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Additional information

Two developmental screening studies are available for structural analogues according to OECD guideline 421 or 422. No adverse effects were observed with the structural analogue containing the the chlorotriazine group up to the highest dose tested. The structural analogue with the fluorotriazine group caused minor inflammation in the stomach tissue at 1000 mg/kg bw/day, resulting in slighthly lower body weight gains in pregnant dams further leading to a possible secondary test substance-related slight effect on intrauterine, postnatal and total foetal mortality correlated with a slight effect on pups survival and weight at 1000 mg/kg bw/day. No structural adverse effects were observed in the surviving pups at up to and including 1000 mg/kg bw/day, under the conditions of this study. These secondary effects are typical for fluorine-compounds and were not noted in any chlorine-compounds. The NOAEL for Reactive Red 239 is therefore considered to be 1000 mg/kg bw/day regarding reproductive toxicity.

Short description of key information:
No adverse effects on reproduction were observed taking in regard the results with the structural analogues

Effects on developmental toxicity

Description of key information

No adverse effects on development of rats were observed in structural analogues

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The read across studies have been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Additional information

The structual analogue (SA02) was tested for developmental toxicity according to OECD TG 414 and GLP (Wistar rats, treatment d 5 – d 19, doses: 100, 300, 1000 mg/kg bw/day, oral gavage, pairing males: females = 1:2).

No test item related adverse findings were reported including bodyweight data, pregnancy rate, prenatal data litter data. The number of gross external abnormalities and skeletal abnormalities compared favourably between treatment groups and controls. Internal observation of the fetal viscera by free hand microdissection technique revealed a range of visceral abnormalities in all groups including control. There was statistically significant increase in heart hyperemia (without the aneurysmal changes) in MD and HD groups. This finding was observed with very less severity and showed lack of dose dependency. The terminally sacrificed animals belonging to the control and LD group revealed no findings, but there were lesions like spleen enlarged, lung with red spots and discolored kidney observed in MD or HD groups. These finding were observed in few individual animals and were not considered treatment related.

In conclusion, the repeated dose administration of the test substance to pregnant female Wistar rats at dosages of 100, 300 and 1000 mg/kg bw/day from Gestation Day 5 to 19 revealed no major toxicological findings in females and fetuses.

Based on the data generated from this study, the NOAEL for both maternal toxicity and fetal toxicity in Wistar rats was 1000 mg/kg bw/day.

Justification for classification or non-classification

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for reproductive effects is therefore required.