Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

In a developmental/reproduction screening study performed according to OECD 421, the potential adverse effect of SP-334 (2 -(2 -hexyl-decyloxy)-benzamide) on reproduction and developmental parameters in rats was assessed (Flaškárová, 2011).

12 Wistar rats/dose/sex were administered 0, 50, 200 and 1000 mg/kg bw/d; males for 28 days during the pre-mating and mating periods, and females for up to 56 days during the pre-mating, mating, and gestation period and during lactation until day 4.

There were 3 unscheduled cases of mortality in female dose groups; 2/12 in the 50 mg/kg bw/d group and 1/12 in the 1000 mg/kg bw/d group, respectively. The animals had inflammation of the endometrium, which is not considered to be test substance-related. The relative liver weight of males administered 1000 mg/kg bw/d was statistically significantly increased, compared to the male control group. This effect is considered to be an adaptation due to higher metabolism in the liver caused by intake of the test substance, rather than an adverse effect. No treatment-related findings were noted during gross necropsy and histopathological examination.

The NOAEL for systemic toxicity is considered to be 1000 mg/kg bw/d for male and female rats, as no effects were noted up to and including the highest dose level.

 

A statistically significant increase in gestation period (≥ 23 days) was noted in the 200 and 1000 mg/kg bw/d groups. However, the number was highest in the 200 mg/kg bw/d group (8/10 pregnant females) and the number in the 1000 mg/kg bw/d group was the same as for the control group (4/9 pregnant females). As the results are not dose-related and there are no other effects on reproductive parameters, this is not considered to be a effect with toxicological significance. There was no statistically significant difference in other reproductive parameters between the control group and treatment groups. The NOAEL for reproduction in males and females is considered to be 1000 mg/kg bw/d, as no effects were observed up to and including the highest dose level.

 

There were no substance-related effects on offspring viability. No clinical signs of toxicity were observed in the offspring and there were no effects on the body weight. No treatment-related effects were observed up to and including the highest dose level, therefore the NOAEL for developmental effects is considered to be 1000 mg/kg bw/d for male and female rats.


Short description of key information:
Developmental/reproduction toxicity screening test (OECD 421), rat, gavage:
NOAEL reproduction (P) ≥ 1000 mg/kg bw/d (males/females)
NOAEL systemic toxicity (P, F1) ≥ 1000 mg/kg bw/d (males/females)

Effects on developmental toxicity

Description of key information
Developmental/reproduction toxicity screening test (OECD 421), rat, gavage: 
NOAEL developmental (F1) ≥ 1000 mg/kg bw/d (males/females)
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

In a developmental/reproduction toxicity screening study performed according to OECD 421, the potential adverse effect of SP-334 (2 -(2 -hexyldecyloxy)-benzamide) on reproduction and developmental parameters in rats was assessed (Flaškárová, 2011).

There were no substance-related effects on offspring viability. No clinical signs of toxicity were observed in the offspring and there were no effects on the body weight. In conclusion, the NOAEL for developmental effects is considered to be 1000 mg/kg bw/d.

Justification for classification or non-classification

The available data on fertility, reproduction, development and effects via lactation do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.