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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Valid experimental data were available to assess the genetic toxicity in vitro and in vivo.


Gene mutation in bacteria:

Glycerol, ethoxylated, esters with acrylic acid was not mutagenic in a standard plate test and in a pre-incubation test with and without metabolic activation, tested at 0, 20, 100, 500, 2500 and 5000 µg/plate in both the SPT and the PIT in Salmonella typhimurium TA1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA; S9 fraction was from the liver of male Sprague-Dawley rats, treated with a single dose of 500 mg/kg bw Aroclor 1254 five days before sacrifice and mixed with a series of cofactors (comp. OECD 471; BASF AG 1989). Cytotoxicity was observed at >= 2500 µg/plate in both the SPT and PIT; depending on strain and test condition.



Gene mutation in mammalian cells:

Glycerol, ethoxylated, esters with acrylic acid was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro. Two independent experiments were carried out, both with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation).

Test concentrations were between 0.08 and 7.50 μg/mL without metabolic activation, and between 2.50 and 100 µg/mL with metabolic activation.

After an attachment period of 20 - 24 hours and a treatment period of 4 hours both with and without metabolic activation and 24 hours without metabolic activation, an expression phase of about 6 - 8 days and a selection period of about 1 week followed. The colonies of each test group were fixed with methanol, stained with Giemsa and counted.

The vehicle controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, ethyl methanesulfonate and methylcholanthrene, led to the expected increase in the frequencies of forward mutations.

In this study, in both experiments in the absence and the presence of metabolic activation the highest concentrations evaluated for gene mutations were clearly cytotoxic.

On the basis from the results of the present study, the test substance did not cause any relevant increase in the mutant frequencies both without S9 mix and after adding a metabolizing system in two experiments performed independently of each other.

Thus, under the experimental conditions of this study, the test substance Glycerin 3EOTA is not mutagenic in the HPRT locus assay under in vitro conditions in CHO cells in the absence and the presence of metabolic activation.

There is no chromosome aberration test in vitro with mammalian cells available.



In vivo:

In a mouse micronucleus assay in polychromatic erythrocytes Glycerol, ethoxylated, esters with acrylic acid led to a negative result after single oral administration of 500, 1000, 2000 mg/kg bw. Sampling times were 24 (all treatments) and 48 h (control and high dose) (BASF AG 2004, Val. 1). As a negative control, male mice were administered the vehicle, olive oil, by the same route, which gave frequencies of micronucleated polychromatic erythrocytes within the historical control range. Both of the positive control chemicals, i.e. cyclophosphamide for clastogenicity and vincristine for spindle poison effects, led to the expected increase in the rate of polychromatic erythrocytes containing small or large micronuclei. Animals which were administered the vehicle or the positive control substances cyclophosphamide or vincristine did not show any clinical signs of toxicity. The single oral administration of olive oil in a volume of 10 ml/kg body weight led to 1.3‰ polychromatic erythrocytes containing micronuclei after the 24-hour sacrifice interval or to 1.7‰ after the 48-hour sacrifice interval. After the single administration of the highest dose of 2000 mg/kg body weight, 1.9‰ polychromatic erythrocytes containing micronuclei were found after 24 hours and 1.7‰ after 48 hours. In the two lower dose groups, rates of micronuclei of about 1.6‰ (1000 mg/kg group) and 1.8‰ (500 mg/kg group) were detected after a sacrifice interval of 24 hours in each case. With 13.3‰ the positive control substance cyclophosphamide for clastogenicity led to the expected clear increase in the number of polychromatic erythrocytes containing mainly small micronuclei. With 40.4‰ the positive control vincristine for spindle poison effects also led to a clearly enhanced number of polychromatic erythrocytes containing micronuclei with the expected amount of large micronuclei, i.e. 8.4‰. The number of normochromatic erythrocytes containing micronuclei did not differ to any appreciable extent in the negative control or in the various dose groups at any of the sacrifice intervals. No inhibition of erythropoiesis induced by the treatment of mice with Glycerin3EOTA was detected. The ratio of polychromatic to normochromatic erythrocytes was always in the same range as that of the control values in all dose groups.

All test results obtained from Ames test, HPRT test and micronucleus test in vivo were negative and therefore the substance is considered to be non genotoxic.

Short description of key information:
Gene mutation in bacteria (Ames assay)
Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98; E. coli WP2 uvrA, with and without metabolic activation: negative (acc. OECD 471, BASF AG 2004, Val. 1)

Gene mutation in mammalian cells (HPRT assay)
CHO cells, with and without metabolic activation: negative (acc. OECD 476, BASF SE 2010, Val. 1)

Mouse, MNT in-vivo: negative (acc. OECD 474, BASF AG 2005)

Endpoint Conclusion:

Justification for classification or non-classification

The test substance was neither genotoxic in in vitro experiments using bacterial or mammalian cells, nor in an in vivo micronucleus assay in mice.

Therefore the test material does not fulfill the requirements to be classified regarding this endpoint.

Thus, based on the available data, no classification of the substance concerning genetic toxicity is warranted.

  • EU classification according to Annex VI of Directive 67/548/EEC: no classification required
  • GHS classification (REGULATION (EC) No 1272/2008 (CLP)):no classification required