Registration Dossier

Administrative data

Description of key information

Read across studies
PETIA: rat, oral: NOAEL systemic = 75mg/kg (OECD 422, GLP, 2010)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

No data are available for Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid. Thus read across was performed to the structurally similar substance 2-Propenoic acid, reaction products with pentaerythritol (PETIA, CAS 1245638-61-2), which in comparison to Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid lacks the chain elements derived from 1-chloro-2,3 epoxipropane in between the pentaerythritol and acrylic acid groups. Consequently this lead to a lower molecular weight of app. 300g/mol compared to app 850g/mol for the oligomere. Both substances are liquids with a low vapour pressure << 0.01hPa and low water solubility of approximately 500-700mg/l. Because of the increased chain length, the log Pow for Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid is slightly higher than the value for PETIA (>3 compared to 1-3). Both substances are moderate skin sensitizers, but due to the higher amount of acrylic acid on a weight per weight basis, which is presumably quickly hydrolysed, PETIA shows an increased irritation potential, i.e., skin irritation, eye corrosion and low acute oral toxicity as a consequence of severe mucosal irritation / erosion. Thus using data from PETIA is a reasonable worst case approach to evaluate the toxicity of Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid.

Pentaerythritol triacrylate was tested in an OECD 422 combined repeated dose/reproduction and developmental toxicity screening study via oral route with CRL:CD(SD) rats at concentrations of 0, 25, 75 and 200 mg/kg. Test substance-related clinical findings were noted in a dose-related manner across all dosage levels and included salivation or evidence thereof, yellow and red material primarily around the mouth, and wiping of mouth in the bedding (females only). Incidences of rales were also noted in the 75 and 200 mg/kg bw/day group males and females sporadically during the treatment period. All of the aforementioned clinical findings were primarily noted at the time of dose administration and/or approximately 1 hour following dose administration, and were attributed to the irritative properties of the test substance, and therefore, were not considered adverse. The indicated test substance-related findings at 75 and 200 mg/kg bw/day relating to mortality/morbidity, adrenal gland weights, neutrophil counts, macroscopic and/or microscopic findings of the stomach, adrenal cortex and thymus were attributed to the irritative properties of the test substance and corresponding stress, rather than systemic toxicity. Based on test substance-related lower mean body weight gains during the overall study period for the 200 mg/kg bw/day males as well as a lower mean body weight on day 27, the NOAEL for systemic toxicity was considered to be 75 mg/kg bw/day.

Justification for classification or non-classification

No specific target organ toxicity was oberseved. The primary effect in the repeated dose study was local irritation. Thus Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid does not have to be classified according to 67/548/EEC or CLP/EU-GHS.