Decyl oleate

Endpoint summary

Description of key information

Study on oral subacute repeated dose toxicity was available for (CAS No.):3687-46-5.
Key, Potokar, 1987, Cognis, 28d oral rat, RL2- 1000 mg/ kg bw/ day
There were no dermal or inhalation repeat dose toxicity studies available for any of the category members.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

A reliable repeated dose 28-day oral toxicity study was performed (CAS No. 3687 -46 -5) equivalent to OECD Guideline 407 (Potokar, 1987). Groups of 10 male and female Wistar rats received daily oral gavage doses of the test substance at concentrations of 0, 100, 500 and 1000 mg/kg/ bw/d in olive oil. Concurrent negative control animals received the vehicle alone. Clinical observations, body weight changes, haematology, clinical chemistry, organ weight measurements as well as gross and histopathologic examinations revealed no treatment-related abnormalities or adverse effects. Based on the study results, the 28 day oral NOAEL for male and female Wistar rats was found to be 1000 mg/kg bw/d.

A 28 day oral repeat dose study was conducted in male and female rats, using three doses (100, 500 and 1000 mg/kg bw day) of Decyl octadec-9-enoate (CAS No. 3687-46-5). No further information was given on exposure of the animals and further design until sacrifice of the animals. At the end of the study period, serum of the rats was collected and several clinico-chemical examinations were conducted. The results of the study were comparable to the control (Bartnik, 1983). However this study was disregarded as it was deemed insufficient for assessment due to missing information on methodology (no information on exposure and study design until sacrifice of the animal).

The read-across substance methyl dodecanoate (CAS# 111 -82 -0) was studied for oral toxicity in rats in an OECD 422 combined repeat dose and reproductive/developmental toxicity screening test (Key JECDB). Though the carbon chain length of the alcoholic component is shorter for methyl laurate (one carbon atom) than for the substances within the LCAE category (ten to eighteen carbon atoms), methyl laurate is considered to represent a suitable read across substance for the following reasons: As the toxic effects of primary aliphatic alcohols in general increase with decreasing carbon chain length, methanol is considered to represent the most critical metabolite of the alcoholic component which can result from hydrolysis of a fatty acid ester.

12 male and female Crj: CD (SD) rats per dose were administered doses of 0, 250, 500 and 1000 mg/kg/day methyl laurate by gavage. The animals were mated. The test material was administered to females from 14 days before mating until day 3 of lactation and to males for 45 days. Terminal kill was on day 45 for males and on day 4 of lactation for females.

The test substance showed no general toxicological effects in either sex. There were no clinical observations attributable to the administration of test substance and there was no mortality in any of the groups. No effects were observed in terms of body weights, food consumption, haematology, blood chemistry, organ weight, necropsy or histopathological findings.

Therefore, under the experimental conditions of the study the NOAEL for methyl dodecanoate for repeated dose toxicity after oral administration is 1000 mg/kg bw/day in both sexes.

Based on the molecular weight ratio this refers to a equimolar NAEL for 9-Octadecenoic acid (9Z) -, decyl ester of 1972.19 mg/kg bw/d.

MW of 9-Octadecenoic acid (9Z) -, decyl ester: 422.74

MW of methyl laurate: 214.35

molar ratio factor = (422.74/214.35) = 1.97

Justification for classification or non-classification

According to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for repeated dose toxicity, no classification is required.