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Key value for chemical safety assessment

Additional information

In vitro:

The substance Adamantyltrimethylammoniumhydroxid 20% was tested for mutagenicity in the Salmonella typhimurium/Escherichia coli reverse mutation assay both in the standard plate test and in the preincubation test with and without the addition of a metabolizing system

(S9 mix) obtained from rat liver using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA (BASF SE, 2008). The study was performed according to OECD guideline 471 in compliance with GLP.

The test substance did not lead to an increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in three experiments carried out independently of each other (standard plate test and preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above.

Thus, it is concluded that Adamantyltrimethylammoniumhydroxid 20% is not a mutagenic substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.

In vivo:

There are no data available concerning genetic toxicity in vivo.


Short description of key information:
In vitro: Ames test negative +/- metabolic activation (BASF SE, 2008)
In vivo: No data available

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 due to lacking data

GHS classification according toAnnex I 1272/2008 CLP (EU GHS):

No classification due to lacking data

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