Reaction mass of dodecyl acrylate and tridecyl acrylate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

No repeated toxicity study is available on the registered substance (reaction mass of C12 -C13 acrylate). However the data are available on an analogue substance (reaction mass of C12 -C14 acrylate). Indeed, Laurylacrylate (C12 -C14) didn’t show adverse toxicity in the screening reproduction study (OECD 422) in rats exposed by gavage at the highest tested dose (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

Quality of whole database:

The study is considered to be reliable with a klimisch score of 1 (reliable without restriction)

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 on analogue substance (OECD 422)

The objective of the OECD 422 study was to detect possible effects of the test substance on the integrity and performance of male and female reproductive systems including gonadal function, mating behavior, conception, gestation and parturition. Furthermore, it was intended to obtain information about the general toxicological profile including target organs and the no observed adverse effect level (NOAEL) after repeated oral administration. The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation and two weeks thereafter in females.

Lauryacrylate 1214 was administered orally via gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0, 100, 300 and 1000 mg/kg bw/d (respectovely test groups 0,1,2 and 3).

Regarding clinical examinations, no signs of general systemic toxicity were observed in male or female parental animals of test groups 1-3 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 during the entire study. Regarding developmental toxicity, no biologically relevant signs of toxicity were observed in male or female pups of all test groups. 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.The NOAEL (no observed adverse effect level) for general, systemic toxicity was 1000 mg/kg bw/d.

The NOAEL for reproductive performance and fertility was 1000 mg/kg bw/d for the F0 parental rats.

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

Effects on developmental toxicity

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results, no classification for the reaction mass of C12/C13 acrylate is required for reprotoxicity according to the Regulation EC n°1272/2008.