Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

According to the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII, no data on reproductive toxicity are provided.

However, based on the RAC opinion, quinolin-8-ol is not considered to affect fertility or reproductive performance. Effects observed in a 2-generation study (including effects on the estrus cycle, changes in the weight of reproductive organs and decreased number of live pups) do not provide sufficient evidence to cause a strong suspicion of impaired fertility in the absence of marked parental toxicity. Furthermore, no concerns for fertility-related abnormalities were raised by the repeated dose toxicity studies.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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

According to the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII, no data on developmental toxicity are provided.

In a prenatal developmental study in New Zealand White rabbits performed according to OECD TG 414 quinolin-8-ol showed teratogenic effects and developmental toxicity. External malformation (omphalocele) was noted in the offspring at doses ≥ 15 mg/kg bw/day in the absence of maternal toxicity (as cited in RAC opinion). According to the RAC opinion, this effect is of highest concern that occurred also in fetuses at doses without maternal (CNS) toxicity. Based on these results, the registrant follows the proposed classification defined in the RAC opinion for Reproduction Category 1B, H360D according to Regulation (EC) No 1272/2008.

Justification for classification or non-classification

The registrant follows the proposed classification defined in the RAC opinion for Reproduction Category 1B, H360D according to Regulation (EC) No 1272/2008.