2-Propenoic acid, heptadecyl ester, branched

Endpoint summary

Description of key information

2 -propenoic acid, heptadecyl ester, branched was tested in an OECD TG 407 repeated-dose 28 -day toxicity study in wistar rats including a recovery period of 2 weeks administration by gavage. Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) for this test compund in male and female Wistar rats of both seces was 150 mg/kg bw/d.

In two OECD TG 422 combined repeated dose and reproductive/developmental toxicity screening test with the structural analogue 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5) and Behenylacrylate (Acrylate 22 45 %, mixture of CAS no.: 4813-57-4, 48076-38-6, 18299-85-9; C18-22) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day. The NOAEL was determined to 1000 mg/kg bw/day.
Based on these results the NOAEL value of 2-Propenoic acid, heptadecyl ester is also considered to be 1000 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

150 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

GLP and guideline compliant studies.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

2 -propenoic acid, heptadecyl ester branched:

Heptadecyl Acrylate (C17A) was administered by gavage to groups of 5 male and 5 female Wistar rats at dose levels of 0 (test group 0), 50 (test group 1), 150 (test group 2) and 750 mg/kg body weight/day (mg/kg bw/d; test group 3) over a period of 4 weeks (main groups). Additionally, 5 male and 5 female animals of high-dose and control groups were maintained for another 2 weeks without treatment in order to demonstrate reversibility of the possible effects (recovery groups).

Food consumption and body weight were determined weekly.All animalswere checked daily for any abnormal clinically signs before the administration as well as within 2 hours and within 5 hours after the administration (3 times a day). Abnormalities and changes were documented for each animal. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter.Beside this, a functional observational battery (FOB) as well as measurement of motor activity (MA) were carried out towards the end of the administration period. Clinico-chemical and hematological examinations as well as urinalyses were performed towards the end of the administration period. After the administration period all animals were sacrificed and assessed by gross pathology. Organ weights were determined followed by histopathological examinations. The examinations for the recovery animals were adopted according to findings that accurred in the 4 -weeks treatment period. Thus, FOP, MA, as well as sampling for examination of urine parameters were not carried out for animals of the recovery phase.

Findings in test group 750 mg/kg bw/d, no treatment-related, adverse effests wer observed at clinical examinations and clinical pathology.  Liver weight increase (absoIlute/relative) in males (+30.9%/35.2%) and females (+28%/30.7%). Minimal to slight diffuse hepatocellular hypertrophy in for males and slight diffuse hepatocellular hypertrophy in two females. In test group 150 mg/kg bw/d and 50 mg/kg bw/d, no treatment-related, adverse effects were observed. In the recovery group (750 mg/kg bw/d), no treatment-related, adverse effects were observed.

The administration of Heptadecyl Acrylate (C17A) by gavage to male and female Wistar rats for 4 weeks with 2 weeks recovery periodcaused test substance-related, adverse findings at a dose level of 750 mg/kg bw/d taking liver weight changes and diffuse hepatocellular hypertrophy into account. These changes were not observable any more after a 2-weeks recovery period. Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) for this test compound in male and female Wistar rats of both sexes was 150 mg/kg bw/d.

2-Propenoic acid, C12-14-alkyl esters (supporting)

In a well performed OECD TG 422 / GLP study, 10 male and 10 female Wistar rats received the test item 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5) (read across approach) by daily oral gavage administration for 14 days before mating, through mating, gestation and the beginning of the lactation period (until day 4 post-partum, p.p.). The dose-levels were 100, 300 and 1000 mg/kg bw/day. The study included check of clinical signs and mortality, body weight and food consumption, investigation of Functional Observation Battery; (FOB)) and motor activity, blood and urine analysis, macroscopic and microscopic examination, observation and examination of pups. Regarding clinical examinations, no signs of general systemic toxicity were observed in male or female parental animals of test groups 1-3 (100, 300 and 1000 mg/kg bw/day) during the entire study period. Regarding fertility and reproductive performance, no signs of toxicity were observed in male or female parental animals of all test groups (100, 300 and 1000 mg/kg bw/day) during the entire study. Regarding developmental toxicity, no biologically relevant signs of toxicity were observed in male or female pups of all test groups (100, 300 and 1000 mg/kg bw/day). Regarding clinical pathology, no treatment-related, adverse effects were observed up to a dose of the compound of 1000 mg/kg bw/d. Regarding pathology, the liver of male animals of test group 2 and 3 (300 and 1000 mg/kg bw/day, respectively) showed an increase in absolute (group 3 only) and relative weights which was regarded to be adaptive and non-adverse in the absence of histological findings. All other findings recorded were considered to be incidental in nature and not related to treatment.   Thus, under the conditions of this reproduction/developmental toxicity screening test the NOAEL (no observed adverse effect level) for reproductive performance and fertility was 1000 mg/kg bw/day. The NOAEL for developmental toxicity in the F1 progeny was found to be 1000 mg/kg bw/day. The NOAEL for general, systemic toxicity was 1000 mg/kg bw/day.

Behenyl acrylate (supporting)

In another OECD TG 422 / GLP study, 10 male and 10 female Wistar rats received the test item, Behenylacrylate (Acrylate 22 45 %, mixture of CAS no. 4813 -57 -4, 48076 -38 -6, 18299 -85 -9) (Read across approach), by daily oral (gavage) administration for 15 days before mating, through mating, gestation and the beginning of the lactation period (until day 4 post-partum, p.p.). The dose-levels were 100, 300 and 1000 mg/kg bw/day. The study included check of clinical signs and mortality, body weight and food consumption, investigation of Functional Observation Battery; (FOB)) and motor activity, blood and urine analysis, macroscopic and microscopic examination, observation and examination of pups. There were no substance-induced effects on the male and female reproductive performance, nor on the progeny of the parental rats at any dose-level. There were no treatment-related findings at histopathological examination. There was no effect of treatment on mating at any dose-level. The male and female fertility indices were unaffected by treatment. The duration of gestation was similar between the control and test item-treated groups. There was no effect of treatment on the mean number of liveborn pups or on pup death after birth. There were no external pup abnormalities in the control or test item-treated groups. There was no effect of treatment on mean pup body weight or body weight gain for males or females. The sex ratios were similar in the control and test item-treated groups. No relevant findings were observed in the pups sacrificed on PND4. Thus, under the conditions of this reproduction/developmental toxicity screening test the NOAEL (no observed adverse effect level) for reproductive performance and fertility was 1000 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 progeny was found to be 1000 mg/kg bw/day. The NOAEL for general, systemic toxicity was 1000 mg/kg bw/day.  

Justification for classification or non-classification

Based on the results of the repeated dose testing of read across substances, the test item was not classified and labelled for long-term toxicity according to Regulation (EC) No 1272/2008(CLP).