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Toxicological information

Carcinogenicity

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Description of key information

key information is based on read-across from monochloroacetic acid. Toxicity of SMCA (the sodium salt of MCAA) is identical to that of MCAA. Under physiological conditions both substances are completely ionised and the relevant moiety is the monochloroacetate ion.
Four studies of restricted reliability are available. 2 NTP studies in rats and mice did not show any carcinogenicity, but could not provide a NOAEL for systemic effects (weight loss). The third study (DeAngelo 1997) aimed specifically at liver carcinogenicity, determined a no-effect level for systemic effects (weight loss). A 2-year dermal carcinogenicity study in mice with a single, high dose dis not show any increase in skin papilomas

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
3.5 mg/kg bw/day
Study duration:
chronic

Additional information

although all three oral studies cited above have their deficiencies, taken together they are adequate and sufficient to conclude that MCAA has no systemic carcinogenic activity. The dermal study did not show any neoplastic activity on the skin at a dose that was established to be the maximum tolerated does in terms of causing minimal cytotoxic effects in the skin. Taken together it can be concluded the MCAA is not carcinogenic. This conclusion is in line with the EU RAR for MCAA (2002)

Justification for classification or non-classification

No carcinogenicity was found in two 2 -year carcinogenicity studies in rats and one in mice, nor in a 2 -year dermal carcinogencity study in mice. MCAA does not need to be labeled for carcinogenicitiy.