Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Based on all available information on DMAMP, the data demonstrate that the test substance seems highly unlikely to be carcinogenic and is not classifiable as carcinogen. Further testing is not required under Regulation (EC) 1907/2006, Annex XI, section 1.2.

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

There are no animal data available on carcinogenicity or chronic toxicity of DMAMP. However, modelling of potential metabolites via the OECD QSAR toolbox v.2.0 (2010) did not predict relevant metabolites. Based on the chemical structure of DMAMP, no metabolism is expected. Therefore, it can be assumed that DMAMP will not show chemically reactive properties under in-vitro and in-vivo test conditions. Available studies via the oral and dermal route indicate that the biological properties of DMAMP are mainly governed by its intrinsic alkalinity.

DMAMP is not mutagenic or clastogenic in the available genetic toxicity studies and there is no evidence of neoplasia in repeated dose toxicity studies. Moreover, DMAMP bears no structural similarity to known carcinogens and has no functional groups associated with carcinogenicity. Therefore, it is concluded that DMAMP does not possess a carcinogenic potential.

Justification for classification or non-classification

Based on all available information on DMAMP, it is expected that DMAMP has no carcinogenic potential.The available data do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.