Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

The data obtained form the reproduction/developmental toxicity screening with undecylenic acid is used for methyl 10 -undecenoate becauseit has beend demonstrated from the hydrolysis pH test that undecylenic acid is the major hydrolysis product of Methyl-10 -undecenoate under gastric pH conditions.

In the rat reproduction/developmental toxicity screening test performed according to OECD 421 guideline with UNDECYLENIC ACID at 50, 150 and 450 mg/kg/day, parental toxicity was being observed at the highest dose level of 450 mg / kg bw / day (two deaths, respiratory difficuties). No effects on reproductive performance nor developmental toxicity effects were noted up to this highest dose level.


Short description of key information:
Toxicity for reproduction : 1 test in rats according to the OECD 421 guideline (CIT 2009). The read-across from a reproduction/developmental toxicity screening test performed on the structural analogue undecylenic acid is being proposed.
There is no two-generation test. There are a screening reprotoxicity test according to OECD 421 guideline and a developmental toxicity test in rats according to OECD 414 guideline. No alerts were observed regarding fertility, mating, pregnancy or embryofetal development.

Effects on developmental toxicity

Description of key information
Developmental toxicity : 1 test with rats according to the OECD 414 guideline (CIT 2007).
The read-across from a rat prenatal development toxicity study on the structural analogue undecylenic acid is being proposed. It was demonstrated in a pH hydrolysis test that Methyl 10-undecenoate undergo rapid hydrolysis to undecylenic acid under gastric pH conditions. In vivo data obtained from undecylenic acid can therefore be used as read accross to evaluate Methyl10-undecenoate. 
Furthermore, a rabbit prenatal developmental study is being proposed for undecylenic acid and will be used for methyl undecylenate developmental evaluation.
Effect on developmental toxicity: via oral route
Dose descriptor:
LOAEL
450 mg/kg bw/day
Additional information

In the prenatal developmental study in rats performed according to OECD 414, undecylenic acid was administered by oral gavage at 50, 450 and 750 mg/kg/day,

Unexpectedly high mortality in the high dose group led to the decision to terminate the treatment of this group. All animals of the intermediate dose group exhibited hypersalivation, and a significantly reduced body weight gain compared to control. In the low dose group, no relevant effects were observed. Hypersalivation in half of the animals was not considered as a relevant sign of toxicity.

No effects or uncommon findings were observed in the fetuses of the animals (malformations observed in a single fetus of the low dose group was considered incidental).

Consequently, the NOAEL for maternal toxicity was set to 150 mg/kg bw/day, while the LOAEL for this parameter was 450 mg/kg bw/day based on body weight and clinical signs. No signs of teratogenicity/developmental toxicity were observed in the study, and the NOAEL ws set to the highest dose level, 450 mg/kg bw/day (750 mg/kg bw/day was discontinued before end of study). A LOAEL for teratogenicity was not observed.

Justification for classification or non-classification

In the reproduction developmental toxicity study (OED 421) and in the prenatal development toxicity study with the source chemical undecylenic acid, no effects on fertility or teratogenicity were observed. Therefore, no classification is warranted for methyl-10 -undecenoate as to its reprotoxic properties according to EU regulation (EC) No 1272/2008 (CLP) andto EU Directive 67/584/EEC.

Additional information