Tetradecyl acrylate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

In a 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) 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, tetradecyl ester is also considered to be 1000 mg/kg bw/day.

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

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) (Read across)

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/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, nosigns 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.

Conclusion: Based on these results the NOAEL of 2 -Propenoic acid, tetradecyl ester is also considered to be 1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

In a 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) 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.

Furthermore, in an experimental inhalation study with ethylhexyl acrylate comparable to OECD guideline 414, no developmental toxicity occured up to the highest dose of 100 ppm.

Based on these results the NOAEL of 2-Propenoic acid, tetradecyl 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 adverse effect observed

Dose descriptor:

NOAEC

750 mg/m³

Study duration:

subacute

Species:

rat

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) (Read across)

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.

Regardingclinical examinations, nosigns 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.

Saillenfait et al., 1999, (Read across)

2-EHA was investigated during a study on the relative developmental toxicities of a set of various acrylates (acrylic acid, methyl acrylate, butyl acrylate, hydroxyethyl acrylate, hydroxypropyl acrylate) in Sprague-Dawley rats. For the investigation with 2-EHA groups of 23 to 25 dams were exposed (6 hours/day, whole-body) to atmospheres containing 2-ethylhexyl acrylate (99.7 % purity) at 0, 50, 75, and 100 ppm (approximately 0.38, 0.56, and 0.75 mg/L) during day 6 to day 20 of gestation. Maternal food consumption was measured for the intervals of g.d. 6-13 and of g.d. 13-21. Maternal body weights were recorded on g.d . 0, 6, 13, and 2l. Dams were sacrificed on day 21 of gestation and the uteri were removed and weighed. The number of implantation sites, resorptions, and dead and live fetuses were recorded. Uteri, which had no visible implantation sites, were stained with ammonium sulfite (10 %) for the detection of early resorptions. At sacrifice live fetuses were weighed, sexed, and examined for external anomalies including those of the oral cavity. Half of live fetuses from each litter were examined for either internal soft tissue or for skeletal changes.

There were no maternal deaths in any of the treatment groups. Dams from the 100-ppm groups showed an absolute weight gain of 24±16 g through the period of exposure, which was lower and statistically significantly different from that of the concurrent control group (42 ± 11 g). Also food intake of 24 ± 3 g food/dam/day through the period of exposure of the 100-ppm group was somewhat lower and statistically significantly different in comparison to that of the concurrent control group (27 ± 2 g food/dam/day). No adverse effects were observed on the mean number of implantation sites per litter and on the mean number of live fetuses per litter in any of the 2-EHA exposed groups. The incidences of non-live implants (3.7 - 6.4 %) and of resorption sites per litter (3.7 - 6.1 %) in the treated groups were lower than those of the concurrent control (both 10.1 %). This observation, however, is not considered to be of toxicological significance. Mean fetal body weights were slightly lower in the treated groups, however not statistically significantly different from that of the concurrent control fetuses. Sex ratio was unaffected. No significant differences were observed between the control and the 2-EHA-treated groups in the incidences of gross anomalies or of visceral or skeletal malformations or variations.

In summary, no embryotoxic, teratogenic or fetotoxic properties of 2-EHA had been revealed from this study for concentrations of up to and including 100 ppm. Due to technical limitations exposure to higher concentrations could not be tested. Based on slightly reduced food intake and lower maternal weight gain at the higher exposure level a NOAEC for maternal toxicity of 75 ppm (approximately 0.56 mg/L) was derived from this study. No embryo-/fetotoxic effects were revealed even at the highest tested concentration at which some signs of maternal toxicity had been observed. Therefore, a NOAEC for developmental toxicity of 100 ppm (approximately 0.75 mg/L) was derived from this study.

Based on these results the NOAEL of 2 -Propenoic acid, tetradecyl ester is also considered to be 1000 mg/kg bw/day.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available screening studies are reliable and suitable for classification purposes under Regulation 1272/2008. As no substance-related adverse findings were noted up to the highest test dose, the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.

During the four days covered in the screening study, no effects via lactation were observed.