Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Waiving.

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

Effects on developmental toxicity

Description of key information

Pregnant rats dosed during organogenesis: NOAEL = 15 mg/kg/day, corresponding to ca. 13 mg/kg a.i..

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
13 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Study well conducted and documented; details 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

Preliminary teratology study

Method

Groups of 6 sexually mature female rats administered by gavage 0, 5, 20, 80 mg/kg/day from day 6 to 15 of gestation. All females were sacrificed on day 20.

Results

No adverse effects were noted at a dose of 5 mg/kg/day; transient effects in terms of reduced weight gain and food intake were noted at 20 mg/kg/day (17 mg/kg a.i.); marked adverse effects were reported at 80 mg/kg/day (68 mg/kg a.i.), where 5/6 females were terminated before the end of the treatment. No indication of teratogenic effects was noted.

Main teratology study

Method

Groups of 21 sexually mature female rats administered by gavage 0, 1.5, 5, 15 mg/kg/day from day 6 to 15 of gestation. All females were sacrificed on day 20.

Results

No effects on general conditions of dams, body weight, food intake were noted. In addition, there were no adverse effects upon litter size, post-implantation survival or foetal and placental weights. Ossification of the foetal posterior cranial bones was slightly reduced, in a statistically significant way only at 15 mg/kg/day (13 mg/kg a.i.), but there were no adverse morphological changes considered to be treatment-related.

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 of reproductive toxicity in a test covering organogenesis. The only finding was a slightly reduced ossification of the foetal posterior cranial bones, but there were no adverse morphological changes that were considered to be treatment related. On these bases, the substance is considered as non toxic for reproduction.