Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Based on all available data of the substances within the chemical category, the weight of evidence demonstrates that the substances in this chemical category seem highly unlikely to be carcinogenic and are not classifiable as carcinogens. Further testing is not required under Regulation (EC) 1907/2006, Annex XI, section 1.2.

Key value for chemical safety assessment

Additional information

There are no animal data available on carcinogenicity or chronic toxicity of 2-amino-1,3-propanediol (APD) or within the chemical category APD belongs to. The members forming the chemical category are APD, 2-amino-2-methyl-1,3-propanediol (AMPD) and 2-amino-2-ethyl-1,3-propanediol (AEPD). Due to the structural similarity between the members of the category and the similar toxicological properties, APD, AMPD and AEPD form a robust chemical category and read-across within the chemical category is justified.

The modelling of potential metabolites via the OECD QSAR toolbox v.2.0 (2010) did not predict relevant metabolites of the category members. Based on the chemical structure of the parental compounds, no metabolism is expected. Therefore, it can be assumed that aminopropandiols will not show reactive properties under in-vitro and in-vivo test conditions.

The category members are of low concern with regard to systemic toxicity. Available studies via the oral, dermal and intraperitoneal route indicate low acute and repeated dose toxicity. Inhalation is of no concern, because the low vapour pressure means that exposure is unlikely to occur.The results of the acute studies, as well as the repeated dose studies, demonstrate that the main cause of toxicity was the intrinsic alkalinity of the category members at the site of contact.The Cramer classification (related mainly to the oral route) also indicates a low toxicological concern for all the category members. No metabolism by cytochrome P450 enzymes in-vivo is expected; this is supported by predictions from QSAR modelling.

Furthermore, the category members were not mutagenic or clastogenic in the available genetic toxicity studies, bear no structural similarity to known carcinogens, have no functional groups associated with carcinogenicity and did not produce evidence of neoplasia in repeated dose toxicity studies. Therefore it is concluded that the category members do not have a carcinogenic potential.

Justification for classification or non-classification

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