2-Propenoic acid, heptadecyl ester, branched

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

No studies on fertility/developmental toxicity of heptadecyl acrylate were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. Two combined repeated dose toxicity studies with reproduction/developmental toxicity screening test (OECD 422, GLP) are available for the structural analogues2 -propenoic acid, C12 -14 -alkyl ester and behenyl acrylate.

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) (Read across to Laurylacrylate 1214 and Behenylacrylate)

In a well performed OECD TG 422 / GLP study, 10 male and 10 female Wistar rats received the test item Laurylacrylate 1214 (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/day. 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.

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/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.

Short description of key information:
In two well-conducted OECD TG 422 combined repeated dose and reproductive/developmental toxicity screening tests with the structural related 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 of 2-Propenoic acid, heptadecyl ester is also considered to be 1000 mg/kg bw/day.

Justification for selection of Effect on fertility via oral route:
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) are the most similar read across substances compared to heptadecyl acrylate.

Effects on developmental toxicity

Description of key information

In two well-conducted OECD TG 422 combined repeated dose and reproductive/developmental toxicity screening tests 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 of 2-Propenoic acid, heptadecyl ester is also considered to be 1000 mg/kg bw/day.  

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

No studies on fertility/developmental toxicity of heptadecyl acrylate were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. Two combined repeated dose toxicity studies with reproduction/developmental toxicity screening test (OECD 422, GLP) are available for the structural analogues 2 -propenoic acid, C12 -14 -alkyl ester and behenyl acrylate.

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) (Read across to Laurylacrylate 1214 and Behenylacrylate)

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/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/d) 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/d) 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/d). 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/d. The NOAEL for developmental toxicity in the F1 progeny was found to be 1000 mg/kg bw/d. The NOAEL for general, systemic toxicity was 1000 mg/kg bw/d.

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/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/d. The NOAEL for general, systemic toxicity was 1000 mg/kg bw/d.

Justification for selection of Effect on developmental toxicity: via oral route:
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) are the most similar read across substances compared to heptadecyl acrylate.

Justification for classification or non-classification

Based on the results obtained from reproduction/developmental testing of read across substances, the test item was not classified and labelled for toxicity to reproduction/development according to Regulation (EC) No 1272/2008 (CLP).