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Administrative data

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
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No teratogenic or developmental effects were noted in reproductive studies with structural analogues.

A modified one-generation study was carried out with structural analogue 02. This test substance contained a higher content (0.3%) of fluoride as impurity in the test substance resulting in fragility of the incisors and a very low food uptake in high-dose dams. Consequently, the survival rate in the high-dose group was rather low. However, daily oral administration of the test substance to rats during the premating, mating, gestation and lactation period at dose levels of 62.5 or 250 mg/kg body weight/day, where the absolute fluoride uptake was distinctly lower, did not affect food consumption, body weight development, male or female mating/reproductive performance, fertility, gestation length as well as development of their progeny. Daily oral administrations of 1000 mg/kg body weight were well tolerated in rats within the first 5 weeks of treatment, but thereafter, from week 6 onwards, caused mortality due to dental lesions with subsequent disability of food uptake and starvation (clinical picture of dental fluorosis). Consequently, due to the fact that no fluoride is contained in Reactive Red F66813, a NOAEL of 1000 mg/kg body weight is expected for the test substance for parental reproductive performance and their offspring.

In a developmental screening study with structural analogue 04, the only effects noted were unspecific toxic effects resulting in higher intrauterine, postnatal and total foetal mortality at 1000 mg/kg bw/day. In this study, for reproductive toxicity, the no observed effect level (NOEL) for parental/adult effects is considered to be 1000 mg/kg bw/day for the males and 250 mg/kg bw/day for the females, due to the higher intrauterine, postnatal and total foetal mortality at 1000 mg/kg bw/day, correlated with a NOEL of 250 mg/kg bw/day for F1 offspring, based on a possible test substance-related slight effect on pups survival and birth 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. The relation to test substance administration is questionable, however, as a worst case scenario, the NOEL was considered to be 250 mg/kg bw/day for calculation of DNELs.

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
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification necessary