Registration Dossier

Administrative data

Description of key information

Carcinogenicity, mice, dermal, 94 weeks (2 times/week/25µL 10% v/v aceton): not carcinogenic, (Cytec, Kettering Laboratory, 1987, Barkley W.) but less reliable

Key value for chemical safety assessment

Carcinogenicity: via dermal route

Endpoint conclusion
Dose descriptor:
NOAEL
19.5 mg/kg bw/day

Additional information

There are no valid experimental data available to assess the carcinogenicity of ethoxylated trimethylolpropane triacrylate (TMPeoTA). Nevertheless a less reliable study is available delivering supportive information for weigh of evidence approaches.

Studies according to other protocols:

A lifetime study was conducted to assess the carcinogenic potential and chronic dermal toxicity of TMPeoTA in male C3H/HeJ mice (Cytec, Kettering Laboratory, 1987, Barkley W.).Therefore groups of 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. Positive control group received 50 µL twice weekly of 0.025 % benzo(a)pyrene (BaP) in acetone. The skin from all animals was examined histologically for non-neoplastic and neoplastic lesions. Histological examination of internal organs was performed on one half of the mice of each group.Survival (%) in mice treated with TMPeoTA was calculated to be 100, 98, 92, 62, 58, 32 and 24 at 13, 26, 39, 52, 65, 78 and 91 weeks, respectively. 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. Pathological examination revealed infectious diseases; age-related atrophy of testes and keratosis of the epithelium in the forestomach; epithelial papilloma in the urinary bladder (in 1 mouse), angioma in the spleen (in 1 mouse) and liver (in 2 mice) and hepatocellular carcinomas (in 2 mice).In conclusion, TMPeoTA was not carcinogenic in male C3H/HeJ mice.(Applicant calculation of application per day: 1000/30 (correction bw) * 25µL * 0.1 (concentration) 0.82 g/cm3(density correction 20µl TI + 180µL Aceton (ideal calculated))) * 2/7 (two time per week application without depot)=19.5 mg/kg bw/d).

Assessment of in vivo carcinogenicity:

A no concern for carcinogenic potential is derived from the genetic toxicity tests, and a less reliable but negative dermal carcinogenicity test with mice (Cytec, Kettering Laboratory, 1987, Barkley W.). shows no evidence for dermal carcinogenicity of TMPeoTA no increased carcinogenic potential is suspected.

In summary no evidence for carcinogenicity can be reported from animal tests.

Key study assignment:

As there is no adequate relevant and reliable study available no study is assigned as key study.

Justification for classification or non-classification

As there is no evidence from a human or animal study for carcinogenicity the test material does not fulfil the requirement according to GHS (Regulation (EU) 1272/2008) or DPD (67/548/EEC) to be labelled as carcinogen.

Labelling carcinogen:

GHS: no labelling

DSD: no labelling