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Carcinogenicity

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Description of key information

Carcinogenicity, mice, dermal, 94 weeks (2 times/week/25µL 10% v/v aceton): not carcinogenic, (Cytec, Kettering Laboratory, 1987, outdated protocol)

Key value for chemical safety assessment

Additional information

No studies exist for Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate, but for the structurally similar substance Propylidynetrimethanol, ethoxylated, esters with acrylic acid (CAS28961 -43 -5), a lifetime study was conducted to assess its carcinogenic potential. Although the study was performed according to an outdated protocol and is thus not reliable without restriction, though well-documented, it supports the conclusion drawn from the genetic toxicity studies, that there is no concern for a carcinogenic potential.

Male C3H/HeJ mice (50/dose) were topically treated with 25 µL of 10 % v/v in acetone, twice weekly for 94 weeks. The dose and concentration of each material were selected after completion of a pilot study. Control animals received no treatment or 50 µL of acetone twice weekly. The positive control group received 50 µL of 0.025 % benzo(a)pyrene (BaP) in acetone twice weekly. No significant difference in body weight gains was observed between the test and control groups. Slight to moderate hyperkeratosis (in 12 mice); no treatment-related skin neoplasms (one lesion, diagnosed grossly as a skin tumor, was actually an abscess in the dermis; skin tumor in another mouse was a metastasis from lymphocytic lymphoma) were observed at the application sites. Examination of internal organs revealed no treatment related lesions.

Read across justification

Propylidynetrimethanol, ethoxylated, esters with acrylic acid (CAS28961 -43 -5) is structurally similar toOxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate (CAS118800 -30 -9). Both molecules show no acute toxicity after oral or dermal exposure and did not induce gene mutations in bacteria or mammalian cells. In a developmental toxicity study using the read across substancePropylidynetrimethanol, ethoxylated, esters with acrylic acidat 1000mg/kg b.w., poor general state and weight loss were observed in maternal animals, presumably as the result of local irritation of the gastrointestinal tract. Erosions in the stomach accompanied by weight loss within one week were also observed in a range finding test conducted with Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate using 600 and 1000mg/kg b.w.

The missing propoxy elements in CAS28961 -43 -5 shorten the chain between the propylidynetrimethanol and the acrylic acid groups, leading to a lower molecular weight of app. 433g/mol and lower logPow of 2.89. It is reasonable to assume, that this also leads to a higher reactivity (i.e., an eye irritating and skin sensitizing potential, which is not observed for CAS118800 -30 -9), since the not ethoxylated Trimethylolpropane triacrylate (moleculare weight 296mg/mol, logPow 0.67) shows a further increased sensitizing potential in addition to eye and skin irritation, while also not being acutely toxic or mutagenic. Thus using data from 28961 -43 -5 is a reasonable worst case approach to cover the endpoints required for Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate.

Justification for classification or non-classification

Oxirane, methyl-, polymer with oxirane, ether with 2 -ethyl-2 -(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate did not induce gene mutations in bacteriy or mammalian cells. A less reliable carcinogenicity study with the read across substance Propylidynetrimethanol, ethoxylated, esters with acrylic acid, caused no concern for a carcinogenic potential. Taken together, there is no reason to assume, that the test substance is carcinogenic. Thus, it is not classified according to EU criteria (67/548/EEC) or CLP/EU-GHS.