Registration Dossier
Registration Dossier
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EC number: 406-640-0 | CAS number: 136920-07-5 KEROFLUX ES 3241
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
in vitro
Gene mutation
In an Ames test according to OECD guideline No. 471 and GLP requirements, S. typhimurium tester strains TA97, TA100, TA1535 and TA1537 were used in both a Standard Plate Test and a Preincubation Test, both with and without metabolic activation (BASF AG 1991). The test substance was dissolved in tetrahydrofurane (THF). No mutagenic activity was found in concentrations ranging from 20 ug - 5000 µg/plate. Precipitation was observed in doses >= 2500 µg/plate. Positive and negative/ vehicle control results were valid.
Cytogenicity
An GLP conform in vitro mammalian chromosome aberration test was performed in accordance with the OECD guideline 473 with and without metabolic activation in V79 cells (BASF AG 1995). Test concentrations ranged from 0.8 - 20 ug/ml. The test substance is considered to be a chromosome-damaging (clastogenic) agent in V79 cells since the test substance caused a statistically significant and dose-dependent increase in the number of structurally aberrant metaphases incl. and excl. gaps after adding a metabolizing system in two experiments independent of each other. An increase in the frequency of cells containing numerical aberrations was not demonstrated. Positive and negative/ vehicle control results were valid.
in vivo
Cytogenicity
A micronucleus test was performed with NMRI mice according to OECD guideline 474 and GLP requirements (BASF AG 1991). The test substance was applied once per gavage in concentrations of 3000 mg/kg, 1500 mg/kg and 750 mg/kg body weight in a volume of 10 ml/kg body weight. 24 hrs after application, the test substance showed no chromosome-damaging (clastogenic) effect, and there were no indications of any impairment of chromosome distribution in the course of mitosis. Negative results were also provided after highdose treatment and sacrifice intervals of 16 and 48 hrs. Positive and negative control results were valid.
An unscheduled DNA synthesis (UDS) test according to OECD guideline 486 and GLP requirements was performed in Wistar rats (BASF AG 1997). The test substance was administered as single gavage administration of 1,000 mg/kg and 2,000 mg/kg body weight in a volume of 10 ml/kg body weight. Hepatocytes were harvested after 3 or 14 hrs. In each case the treatment did not lead to an increase in the mean number of net nuclear grain counts at any dose level or exposure time in rat hepatocytes. Positive and negative control results were valid.
Short description of key information:
in vitro
Ames (TA97, TA100, TA1535, TA1537): negativ w/ and w/out S9 (GLP, OECD471, BASF 1991)
Chrom. aberration: positiv w/S9, negativ w/out S9 (GLP, OECD 473, BASF 1995)
in vivo
MNT: negative (GLP, OECD 474, BASF 1991)
UDS: negative (GLP, OECD 486, BASF 1997)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Keroflux ES 3241 showed a chromosome-damaging (clastogenic) potential in V79 cells in a chromosome aberration test. This potential was not expressed in vivo, since two guideline conform cytogenicity assays produced negative results. A classification of the genotoxic potential of the test substance is therefore not warranted.
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