N,N-dimethyloctanamide

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

Studies used in this section were conducted with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyldodecanamide and N,N-dimethylhexanamide). It is assumed that, due to the fact that a high amount in the mixture was N,N-dimethyl-octanamid the rest of the mixture are homologues with a lower and higher molecular weight, the mixture has the similar toxicological behavior than pure N,N-dimethyl-octanamid.

No independent studies for toxicity to fertility are available.

However a 90 days repeated dose studies with a mixture of a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide in beagle dogs via gavage (40, 200 and 1000 mg/kg bw/d; Bayer 2000, J. Ruf) reported no relevant findings regarding the male or female fertility/developmental toxicity .

It is assumed that a reproductive screening study or two generation study does not need to be conducted as results from a developmental toxicity study and a subchronic toxicity study did not reveal any reason of concern for offspring and for parent animals with respect to developmental toxicity or fertility.

Key study assignment:

No key study is assigned for this endpoint.

Short description of key information:
No effects on fertility are expected.

Effects on developmental toxicity

Description of key information

- oral, rat, gavage, 6-15 post coitum, mixture of N,N-dimethyl-decanamide and N,N-dimethyl-octanamide, OECD 414: NOAEL (maternal) 50 mg/kg bw/d; NOAEL (fetal) 150 mg/kg bw/d; discreminating dose teratogenicity 450mg/kg bw  (no teratogenic potential). (RCC 1991, H. Becker) 

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

450 mg/kg bw/day

Species:

rat

Additional information

Studies used in this section were conducted with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyl-dodecanamide and N,N-dimethyl-hexanamide). It is assumed that due to the fact that a high amount in the mixture was N,N-dimethyl-octanamide and the rest of the mixture are homologues with a lower and higher molecular weight, the mixture has the identical toxicological behaviour than pure N,N-dimethyloctanamide.

Valid experimental data are available to assess the teratogenicity in rats with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyl-dodecanamide and N,N-dimethyl-hexanamid).

In a study according to OECD 414 (Bayer, RCC, 1991, H. Becker) the mixture was administered orally by gavage, once daily, to mated female Wistar rats at dosages of 50, 150 or 450 mg/kg body weight/day from day 6 through to day 15 post coitum in order to assess the effects on embryonic and fetal development. In the dams at 450 mg/kg body weight/day, severe clinical signs of reaction to treatment, reduced food consumption and reduced body weight gain were observed. Additionally, at this dose level slightly increased post-implantation loss, reduced mean fetal body weights, an increased incidence of fetuses with common abnormal skeletal findings and retardations in skeletal development were noted. At 150 mg/kg body weight/day, there was a slight reduction in food consumption during the dosing period. At this dose level no effects on the maternal reproduction parameters or on the fetal parameters were noted. External and visceral examination of the fetuses, did not reveal any treatment related effects up to and including the dose level of 450 mg/kg body weight/day. Based on these results the author concluded that, the no-observed adverse effect level (NOAEL) for the maternal organism was considered to be 50 mg/kg body weight/day and for the fetal organism 150 mg/kg body weight/day and that under the conditions described in this study,the test substancedid not reveal any teratogenic potential up to and including the highest dose level of 450 mg/kg body weight/day.

Assessment of teratogenicity:

The study shows toxic effect to maternal and fetal organism, whereas the maternal organism reacts earlier and the fetus is only affected in higher dosages but the study did not show any teratogenic effect up to and including the highest dosage tested. The NOAELs derived were only based on weight reduction/slight reduced food comsumption by the author and considered by the applicant as not suitable for risk assessment, even as there are better studies available.

Key study assignment:

As there is only one reliable and relevant study available, this study is used as key study.

Justification for selection of Effect on developmental toxicity: via oral route:
Most adequat reliable result, see discussion.

Justification for classification or non-classification

Due to citeria of legislation GHS (Regulation (EU) 1272/2008) for reproductive toxicans ("Suspected human reproductive toxicant Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information......") the substance is not be classified as reproductive toxican as there is no evidence from the current available data. Also according to DSD (67/548/EEC) the available test results led not to a classification as a substance with toxicity to reproduction.

Labelling for toxicity to reproduction:

GHS: no classification

DSD: no classification