(tetrapropenyl)succinic acid

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Under the conditions of the study, oral administration of the test material to male and female Han Wistar rats was well tolerated, with no effect of treatment upon reproductive parameters observed up to the highest dose level tested of 100 mg/kg/day.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

100 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

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

Under the conditions of the study, oral administration of the test material to male and female Han Wistar rats was well tolerated, with no effect of treatment upon developmental parameters observed up to the highest dose level tested of 100 mg/kg/day.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

100 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

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

The potential for the test material to cause reproductive/developmental effects, was investigated in a GLP study conducted in accordance to the standardised guideline OECD 421.

Three groups of ten male and ten female rats received the test material at doses of 16, 40 or 100 mg/kg/day by oral (gavage) administration at a dose volume of 5 mL/kg. Males were treated daily for 15 days before pairing, during the pairing period, and then up to necropsy after a minimum of four consecutive weeks. Females were treated daily for 15 days before pairing, throughout pairing and gestation, and until Day 6 of lactation. Females were allowed to litter and rear their offspring before they were killed on Day 7 of lactation. The F1 generation received no direct administration of the test item; any exposure was in utero or via the milk. A similarly constituted Control group received the vehicle, corn oil, at the same dose volume as the treated groups. During the study, clinical condition, body weight, food consumption, pre-coital interval, mating performance and fertility, gestation length, organ weight and macroscopic pathology and histopathology investigations of organs of the reproductive system were undertaken. The clinical condition, litter size, survival, sex ratio, body weight and macropathology for all offspring were also assessed. The oral (gavage) administration of the test material to Han Wistar (RccHan™;WIST) rats for at least 4 weeks at dose levels of 16, 40 or 100 mg/kg/day was well tolerated, with no deaths

and no effect of treatment upon the clinical condition of animals. There was no effect of treatment on body weight gain or food consumption at any of the dose levels investigated and pre-coital interval, mating performance and fertility and gestation length were unaffected. The number of offspring born, offspring sex ratio and offspring survival and growth to Day 7 of age were unaffected at dose levels up to 100 mg/kg/day and there were no clinical observations or macroscopic necropsy findings amongst offspring that were considered to relate to parental treatment. There were no treatment related macroscopic or microscopic findings, and no differences in organ weights, which were considered to be related to treatment.

It is concluded that oral administration of the test material to male and female Han Wistar (RccHan™;WIST) for at least 4 weeks at dose levels of 16, 40 or 100 mg/kg/day was well tolerated, with no effect of treatment upon reproductive or developmental parameters observed up to the highest dose level tested of 100 mg/kg/day.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to reproductive toxicity.