Registration Dossier
Registration Dossier
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EC number: 285-077-0 | CAS number: 85029-52-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
GLP experimental studies, according to OECD guidelines 471 (Ames Test), OECD 473 (In vitro mammalian chromosome aberration test in chinese hamster V79 cells) and OECD 474 (In vivo Mammalian Erythrocyte Micronucleus Test) scored as Klimisch 1, are selected as key studies. An additional study, based on OECD 471 (Ames Test) but scored as Klimisch 2 because not performed in a GLP laboratory, is selected as key study.
Ames Test
The Ames test, a mutagenic assay in procaryotic cells of Salmonella typhimurium, was carried out with the test substance Acacia Mearnsi in order to study the possible genetic effect on the strain TA97a, TA98, TA100, TA1535. The test was realized with and without metabolic activator. The test substance was tested in five concentrations: 0.001; 0.01; 0.1; 1.0 and 5.0 mg/plate. The positive controls produced the expected increases in the number of revertants. The negative control kept up the number of spontaneous revertants within the reversion rate for each strain. The test substance did not produce an increase in the number of revertants in the system with and without metabolic activator, at any of the studied concentrations when compared with the number of spontaneous revertants of control cultures treated with solvent.
Mammalian Chromosome Aberration:
In conclusion, it can be stated that during the described in vitro chromosome aberration test and under the experimental conditions reported(with and without metabolic activation), the test item Acacia Mearnsi, ext. reaction products with ammonium chloride and formaldehyde did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line.
Therefore, the test item Acacia Mearnsi, ext. reaction products with ammonium chloride and formaldehyde is considered to be non-clastogenic in this chromosome aberration test.
Micronucleus Test
A Micronucleus Assay on Mice was conducted to study potential harmful effects of the test substance Acacia Mearnsi on chromosomes and on the mitosis processes of cells. The test article was used at the doses of 25%, 50% and 75% (112,5, 75 and 37.5 mg/kg) of 0.4 to 0.5 mL/animal for 24 hours. The tested animals were maintained for 24 hours following the application and later sacrificed for the preapration of the slides. No increase in the proportion of micronuclei was observed in the etrythrocytes in the test group in comparison with the control group. The test article was considered non-mutagenic when applied by intraperitoneal route to mice.
Justification for selection of genetic toxicity endpoint
No study was selected since all in vitro studies were negative.
Short description of key information:
Ames Test 1: negative
Ames Test 2: negative
Mammalian Chromosome Aberration in chinese Hamster V79: negative
Mouse micronucleus Test in vivo: negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to the Ames test conducted under the test conditions with Acacia Mearnsi no genotoxicity effect was observed either with or without metabolic activation.
The study on in vitro chromosomal aberration and in vivo micronucleus allows to conclude on the non-classification of Acacia Mearnsi in accordance with Annex I Reg. EU 1272/2008.
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