Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Desmorapid 01 can be chemically described as ‘butanoic acid, 3-oxo-, methylester, reaction products with N,N-dimethyl-1,3-propanediamine and propylene glycol ether with trimethylol propane (3:1) (CAS-No. 646505-36-4)’ or (different description of the same substance) ‘poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate’ (CAS-No. 857285-61-1). The closely related CAS-No. 179733-18-7 describes the same substance and differs only in the manufacturing process where ethanol is distilled off while for the other two CAS-Nos. methanol is distilled off (see IUCLID section 1.1). Thus, toxicological data for all three CAS-Nos. are considered relevant for the substance to be registered and are taken into account for human health assessment.

The test substance (CAS-No. 646505-36-4) was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and TA 102, performed according to OECD TG 471. The test material was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.

The test substance (CAS-No. 646505-36-4) was investigated for a mutagenic potential in an in vitro gene mutation assay on V79 cells (HPRT) according to OECD TG 476 in concentrations of up to and including 180 µg/mL without S9 mix and 900 µg/ml with S9 mix. The highest concentrations induced acceptable levels of cytotoxicity. Cultures with higher concentrations were not continued due to exceedingly strong toxic effects. No relevant and reproducible increase of the mutation frequency was observed in the cultures with and without S9 mix. Based on these results the test substance is considered to be non-mutagenic in the V79/HPRT test.

The clastogenic and aneugenic potential of the test substance (CAS-No. 646505-36-4) was evaluated in an in vitro micronucleus test with Chinese hamster V79 cells according to OECD TG 487. Cytotoxic effects were assessed by relative increase in cell count (RICC) as well as the proliferation index (PI). The micronucleus test showed no increase in the frequencies of micronucleus containing V79 cells treated with the test item in the absence (4 hour or 24 hour treatment) or in the presence of S9 mix (4 hour treatment) up to cytotoxic concentrations. Therefore, the test item is considered to be non-clastogenic (no induction of structural chromsomal aberrations) and non-aneugenic (no induction of misdistribution of chromosomes) under the conditions of the in vitro micronucleus test.

Justification for selection of genetic toxicity endpoint
no study was selected, since all three in vitro studies were negative

Short description of key information:
Clearly negative in vitro studies - both with and without metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results of several mutagenicity tests no classification is required with regard to genetic toxicity.