Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Lactamoil 70% was tested for genotoxicity in three different in vitro test systems:

  1. the bacterial reverse mutation test (according to OECD guideline 471): The test was carried out in two versions, a standard plate test (experiment 1) and a preincubation assay (experiment 2). Both experiments were conducted with and without metabolic activation (S9 mix obtained from rats treated with phenobarbital and beta-naphthoflavone) in the following strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA. The test substance was applied in doses of 33 -10 000 ug/plate. The test substance did not lead to a relevant increase in the number of revertant colonies in any of the experiments.
  2. the gene mutation assay in chinese hamster V79 cells (HPRT test, according to OECD guideline 476): The test was conducted with and without metabolic activation according to the following scheme: Experiment 1: 4 hours treatment +/-S9; experiment 2: 4 hours treatment +S9, 24 hours -S9. The test substance was applied in doses ranging from 26.6 ug/ml to 850 ug/ml, except for 4 hours treatment -S9 in experiment 1 (53.1 -1700 ug/ml). The test substance did not induce a dose-dependent increase in mutation frequency.
  3. the chromosome aberration test in chinese hamster V79 cells (according to OECD guideline 473): The test was conducted with and without a recovery phase after treatment with the test substance (experiments 1 and 2, respectively), each with and without metabolic activation. The test substance was applied in doses ranging from 26.6 to 6800 ug/ml. No relevant increase in the number of cells carrying structural or numeric chromosme aberrations was observed

Together, the results of these tests indicate that Lactamoil 70% is not genotoxic in vitro.


Short description of key information:
Lactamoil 70% was tested in 3 different in vitro genotoxicity tests assessing different endpoints and showed no mutagenic or clastogenic activity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No indication of a genotoxic potential was observed. Thus, no classification is required.