Registration Dossier
Registration Dossier
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EC number: 403-610-9 | CAS number: 122795-41-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test: Negative (OECD TG 471, GLP)
In vivo Micronucleus assay: Negative (similar to OECD TG 474, GLP)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro:
Salmonella typhimuriums trains TA1535, TA1537, TA1538, TA98, TA100 and Escherichia coli strain WP2uvrA were tested according to OECD TG 471. The strains were treated with Neoproxen using the plate incorporation method both with and without the addition of a rat liver homogenate metabolizing system (S9). Neoproxen was toxic towards tester strains TA l00, TA 1535 and TA 98, in the presence and absence of metabolic activation, and TA 1537, in the presence of metabolic activation only. Therefore the test concentrations in three independent tests ranged from 31.25 to 5000 µg/plate. No substantial increases in revertant colony numbers of any of the six tester strains were observed following treatment with Neoproxen at any dose level, either in the presence or absence of metabolic activation (S-9 mix). The test material was considered to be non-mutagenic under the conditions of this test.
In vivo:
In a test according to OECD TG 474, Neoproxen was administered orally by gavage to mice at a dosage of 3519 mg/kg bodyweight. A preliminary toxicity test had been carried out to determine the toxicity. At all sampling times the treated mice showed no significant increase in the frequency of micronucleated polychromatic erythrocytes. There was no significant change in the ratio of polychromatic to normochromatic erythrocytes after treatment of the animals. It is concluded from the results obtained that Neoproxen shows no evidence of mutagenic potential in this in vivo test procedure.
Justification for classification or non-classification
Based on the results of the Ames test (OECD TG 471) and the in vivo micronucleus test (OECD 474), the substance does not need to be classified for genotoxicity according to EU CLP (EC 1272/2008 and its amendments).
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