Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames Test (OECD 471): With the bacterial mutagenicity test (Ames Test) according to OECD 471, a reproducible mutagenic activity of the test compound to any of the tester strains TA 98, TA 100, TA 102, TA 1535 or TA 1537 was not observed with and without metabolic activation neither with the plate incorporation nor with pre-incubation method. It is therefore concluded, that Benzoesäure-isononylester is not a bacterial mutagen.

CA in vitro (OECD 473): In a chromosomal aberrations test in vitro with CHL cells according to OECD 473, the test item did not induce any significant increases in the freguency of cells with aberrations in any of the exposure groups. The vehicle (solvent) control had frequencies of cells with aberrations within the range expected for the CHL cell line. All of the positive control materials induced highly significant increases in the frequency of cells with aberrations indicating the satisfactory performance of the test and of the activity of the metabolising system. The dose levels of the test material were shown to be toxic to CHL cells in vitro and optimal levels of toxicity were achieved in all of the exposure conditions. The test material was considered to be non-clastogenic to CHL cells in vitro.

Micronucleus test in vivo (OECD 474): The ability of BENZOIC ACID ISONONYLESTER to cause chromosomal damage in vivo was investigated in a micronucleus test in rats. Based on results obtained in a preliminary toxicity test, dose-levels selected were 500, 1000 and 2000 mg/kg bodyweight for male and female animals. The test item was administered orally to Sprague-Dawley SD rats once in the vehicle corn oil. Following treatment with Benzoic Acid Isononylester, no statistically significant increase in the incidence of micronucleated PCE's over the control value, was observed in any treatment group. Statistically significant increases in the incidence of micronucleated PCE's over the control values were observed following treatment with the positive control Mitomycin-C, indicating the correct functioning of the test system. Furthermore, a slight depression of bone marrow erythropoietic cell division, was observed at the high and intermediate dose-levels of treatment for female animals from the 24 hour sampling time. A slight depression of bone marrow erythropoietic cell division was also observed at the 48 hour sampling time for both male and female animals from the high dose-group. It is concluded that, under the reported experimental conditions, BENZOIC ACID ISONONYLESTER administered orally at the selected dose-levels to male and female rats, does not induce micronuclei in the polychromatic erythrocytes.


Short description of key information:
Ames Test (OECD 471): 50 - 5000 µg/plate Benzoesäure isononylester - negative
CA in vitro (OECD 473): not clastogenic up to 2000 µg/mL
Micronucleus test in vivo (OECD 474): not clastogenic/mutagenic in vivo
The ability of BENZOIC ACID ISONONYLESTER to cause chromosomal damage in vivo was investigated in a micronucleus test in rats. Based on results obtained in a preliminary toxicity test, dose-levels selected were 500, 1000 and 2000 mg/kg bodyweight for male and female animals. The test item was administered orally.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.2, 2007): no classification required