Registration Dossier

Administrative data

Description of key information

No human data is available. Experimental carcinogenicity studies have not been performed with experimental animals.
Mesamoll was shown to be not genotoxic in vitro in a salmonella/microsome test similar to OECD TG 471 (Bayer AG, Herbold B., 1981), in in vitro chromosomal aberration studies similar to OECD TG 473 (Bayer AG, Nakagawa M., 2003) and in a HPRT assay similar to OECD TG 476 (Bayer AG, Brendler-Schwaab S., 1996).
No evidence of pre-neoplastic leasons was found in repeated dose studies. E.g. in a subchronic 3 month-feeding study in male and female rats no substance related histopatological effects were observed in the organs investigated: aorta, eyes with lids, cecum, duodenum, femur, brain, bladder, testicles, skin, heart, pituitary gland, larynx, head, ileum, jejunum, liver, lung, mesenterial lymph node, mandibular lymph node, stomach, lactiferous gland, spleen, femoral musculature, epididymis, nervus ischiadicus, nervus opticus, kidneys, esophagus, ovaries, oviduct, pancreas, prostata, rectum, cervical, thoracal and lumbal spinal cord, seminal vesicle, thyroid gland, salivary gland, sternum, thymus (if present), trachea, extraorbitary lacrimal gland, uterus, vagina, tongue (Bayer AG, Ramm W., Eiben R., 1987).
Mesamoll has no local irritation potential on mucous membranes in an eye irritation study in rabbits (Bayer AG, Löser E., Kimmerle G., 1975) and on the gastrointestinal tract in oral repeated dose studies (Bayer AG, RammW., Eiben R., 1987).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Conclusion: Overall it can be concluded that there is no evidence to anticipate a carcinogenic potential of Mesamoll based on the absence of a genotoxic potential in multiple in vitro assays similar to current guidelines and no observation of pre-neoplastic lesions in a comprehensive sub-chronic study (Bayer AG, Popp L., 2009).

Justification for classification or non-classification

Classification is not required.