Registration Dossier

Administrative data

Description of key information

A Klimisch 1 rated key study was carried out in 1999. The test item was applied orally for 13 weeks according to OECD 408. The observed NOAEL was 60 mg/kg bw/day, the LOAEL was 180 mg/kg bw/day where the target organ was the heart in which a degenerative cardiomyopathy was seen. Reversibility was observed for this effect . No chronic studies in inhalative or dermal application route conducted.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
60 mg/kg bw/day

Additional information

Oral repeated :

The potential of the test substance, sodium salt of undecylenic acid, to induce toxicity under subchronic repeated oral treatment conditions was investigated in rats according to OECD guideline 408. Male and female Sprague-Dawley rats were treated with the test substance by oral gavage on a daily basis over a period of 90 days. In addition, a satellite group was included that was allowed to recover during a 4 week treatment-free period.

Animals were examined for mortality, clinical signs, food/water consumption, food efficiency and body weight gain throughout the study. At the end of the study, the animals were sacrificed and haematology/clinical chemistry was performed from blood and/or urine. Furthermore, animals were subjected to detailed macroscopic and microscopic pathological investigation.

Treatment with the test substance did not result in mortality, but in dose-dependent observation of clinical signs. The observed signs included ptyalism, loud breathing/respiratory difficulties and poor clinical condition. Body weight gain and food consumption were reduced in males of the high dose group, especially after dose increase starting day 50 of the study. Reduced glucose plasma levels and reduced triglyceride-levels were found in females of the high dose group, the first being reversible and the latter not reversible in the treatment-free period. Histopathology revealed cardiomyopathie in some animals of the highest dose group (myocardial degeneration/monocellular aggregation) which was reversible during treatment free period. Forestomach oedema/inflammatory cell infiltration was observed in the high dose group. There were no treatment related effects in the low and intermediate dose-groups.

Under the experimental conditions, the 13 week oral toxicity study derived NOAEL for the sodium salt of undecylenic acid was 60 mg/kg bw/d (LOAEL = 180 mg/kg bw/d).


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: heart

Justification for classification or non-classification

According to EU regulation (EC) No 1272/2008 (CLP), undecylenic acid is not classified for specific target organ toxicity-repeated exposure.

Justification: LOAEL oral = 180 mg/kg/day and therefore > to the cut off level of 100 mg/kg bw/d (rat, 90 days).

According to EU Directive 67/584/EEC, undecylenic acid is not classified for specific target organ toxicity-repeated exposure.

Justification : no serious damage was observed in this study.