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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Bacterial reverse mutation assay (Ames test)

The test substance was tested for its mutagenic potential based on the ability to induce back mutations in selected loci of several bacterial strains in the Ames test and in the Escherichia coli-reverse mutation assay according to OECD guidelines 471 and 472 in compliance with GLP (BASF AG, 1998).

- Strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA

- Dose range: 20 µg - 5000 µg/plate

- Test conditions: Standard plate test both with and without metabolic activation (Aroclor-induced rat liver S-9 mix)

- Solubility: A precipitation of the test substance was found from about 100 µg/plate onward.

- Toxicity: A slight decrease in the number of revertants was occasionally observed depending on the strain and test condition from about 500 µg - 2500 µg/plate onward.

- Mutagenicity: An increase in the number of his+ or trp+ revertants was not observed in the standard plate test either without S-9 mix or after the addition of a metabolizing system.

Conclusion: According to the results of this study, the test substance is not mutagenic in the Ames test and in the Escherichia coli-reverse mutation assay without or with metabolic activation.

In vitro mammalian cell gene mutation test (HPRT test)

A study was performed to investigate the potential of Polyglycerintribehenat to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster (BASF SE/Harlan, 2012). The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. The highest concentration applied in the pre-experiment was 1600 μg/mL limited by the solubility properties of the test item. The test item was dissolved in THF. The concentration range of the main experiments was limited by the occurrence of precipitation of the test item. The tested concentrations of the main experiments were in experiment I 12.5, 25.0, 50.0, 100.0, 200.0 µg/mL and in experiment II 6.3, 12.5, 25.0, 50.0, 100.0 µg/mL.

No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Appropriate reference mutagens (EMS and DMBA), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.

Conclusion: Under the experimental conditions of this study the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Polyglycerintribehenat is considered to be non-mutagenic in this HPRT assay.

In vitro micronucleus assay in V79 cells

The substance Polyglycerintribehenat was assessed for its potential to induce micronuclei in V79 cells in vitro (clastogenic or aneugenic activity; BASF SE, 2013). Four main experiments using either tetrahydrofurane (THF) or dimethyl sulfoxide (DMSO) as vehicle were carried out with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). The test substance was poorly soluble. The vehicle THF was selected as most suitable vehicle. Due to increased frequencies of micronucleated cells in the vehicle control groups the acceptance criteria were failed in the 1st Experiment in the absence of metabolic activation and in the 2nd Experiment in the absence and presence of metabolic activation. Therefore, both main experiments using the vehicle THF were judged invalid due to the genotoxic potency of the vehicle itself. Therefore, for the assessment of the genotoxic potential of the test substance Polyglycerintribehenat only the data of the 3rd and 4th Experiment using the vehicle DMSO were considered.

Based on the solubility properties of the test substance in DMSO the following doses were tested (the test groups printed in bold type were evaluated):

3rd Experiment:

4 hours exposure, 24 hours harvest time; without S9 mix: 0; 3.91; 7.81; 15.63; 31.25; 62.5; 125; 250 μg/mL

4 hours exposure, 24 hours harvest time, with S9 mix: 0; 3.91; 7.81; 15.63; 31.25; 62.5; 125; 250 μg/mL

4th Experiment:

24 hours exposure, 24 hours harvest time, without S9 mix: 0; 7.81; 15.63; 31.25; 62.5; 125; 250 μg/mL

4 hours exposure, 24 hours harvest time, with S9 mix: 0; 6.25; 12.5; 25; 50; 100 μg/mL

A sample of at least 1000 cells for each culture were analyzed for micronuclei, i.e. 2000 cells for each test group. The vehicle controls gave frequencies of micronucleated cells within our historical negative control data range for V79 cells. Both positive control substances, EMS and cyclophosphamide, led to the expected increase in the number of cells containing micronuclei.

In this study, no cytotoxicity indicated by reduced relative increase in cell count (RICC) or proliferation index (PI) was observed up to the highest applied test substance concentration. On the basis of the results of the present study, the test substance did not cause any biologically relevant increase in the number of cells containing micronuclei either without S9 mix or after adding a metabolizing system.

Conclusion: Under the experimental conditions described, Polyglycerintribehenat is considered not to have a chromosome-damaging (clastogenic) effect nor to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.

Justification for selection of genetic toxicity endpoint
No study was selected because all in vitro studies were negative.

Short description of key information:
The absence of a mutagenic potential was demonstrated for the registered substance in vitro in bacteria (Ames test) and in mammalian cells (HPRT assay). An in vitro micronucleus assay in V79 cells with the registered dye demonstrated that the test sustance has no potential to induce chromosome aberrations.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available results from genetic toxicity studies classification and labelling for genotoxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No. 1272/2008 (CLP) is not warranted.