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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

300 mg/kg bw/day

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Reproductive toxicity was assessed in rats of both sexes orally by gavage at concentrations of 0, 100, 300 and 1000 mg/kg bw/day using distilled water as vehicle. The treatment was administered for up to 51 - 54 days in both males and females, covering pre-mating, mating, gestation period of pregnant females and lactation up to 13 - 15 days post delivery. Then necropsy was performed on parental animals.

At all tested doses, no substance related effects on males fertility were noted.

At 1000 mg/kg bw/day, post-implantation losses were more frequent than in (test or historical) controls. Despite the low difference, a test item influence could not be excluded.

Under the test conditions, the substance did not show effects on reproductive performance of male rats and NOAEL = 1000 mg/kg bw/day was established. Toxicity in terms of post-implantation losses was noted in female rats, with NOAEL = 300 mg/kg bw/day and LOAEL = 1000 mg/kg bw/day.

Short description of key information:
At high dosage (1000 mg/kg bw/day), the substance induces post-implantation losses higher than those encountered in both test control and historical control. Thus, NOAEL = 300 and LOAEL = 1000 mg/kg bw/day.

Justification for selection of Effect on fertility via oral route:
The study is reliable and representative.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Developmental toxicity was evaluated upon administration of test substance to male and female rats at doses of 100, 300 and 1000 mg/kg bw/day orally by gavage using distilled water as vehicle. The treatment was administered for up to 51 - 54 days in both males and females (pregnant or not), covering pre-mating, mating, gestation period and lactation up 13 -15 days post delivery. Then, necropsy was performed on stillborn/dead offspring, where gross pathological and histopathological examinations did no show any alteration at all doses.

In addition, at all tested doses, no substance related clinical signs were detected; no effects on survival indices, sex distribution and body weight were seen. Anogenital distance and nipple retention were similar in control and treated groups.

Justification for selection of Effect on developmental toxicity: via oral route:
The study is reliable and representative.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, adverse effects on developmental toxicity in the offspring and adverse effects on or via lactation.

Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans.

Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1.

Test substance did not show any evidence on reproductive toxicity in a screening test covering fertility, development and lactation. The only finding was an increase of post-implantation losses at high dose (1000 mg/kg bw/day) in rats. For this effect, a NOAEL was established at the mid dose of 300 mg/kg bw/day. On these bases, the substance is considered as non toxic for reproduction.